A Phase 1/2 interventional study of Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody and Bevacizumab in Breast Neoplasms, sponsored by Hoffmann-La Roche. Completed at 22 sites in 3 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-10.
Sponsored by Hoffmann-La Roche · Phase 1/2, Interventional, and Treatment
This study is designed to evaluate the efficacy, safety, and pharmacokinetics of several immunotherapy-based combination treatments in participants with inoperable locally advanced or metastatic HR-positive, HER2-negative breast cancer who have progressed during or following treatment with a cyclin-dependent kinase (CDK) 4/6 inhibitor in the first- or second-line setting, such as palbociclib, ribociclib, or abemaciclib. The study will be performed in two stages. During Stage 1, participants will be randomized to fulvestrant (control) or an atezolizumab-containing doublet or triplet combination. Those who experience disease progression, loss of clinical benefit, or unacceptable toxicity may be eligible to receive a new triplet combination treatment in Stage 2 until loss of clinical benefit or unacceptable toxicity. New treatment arms may be added and/or existing treatment arms may be closed during the course of the study on the basis of ongoing clinical efficacy and safety as well as the current treatments available.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 144 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for Both Stages:
Inclusion Criteria for Stage 1:
Inclusion Criteria for Stage 2:
Exclusion Criteria for Both Stages:
Exclusion Criteria for Stage 1:
Exclusion Criteria for Stage 2:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive fulvestrant until unacceptable toxicity or disease progression according to RECIST v1.1.
Drug: Fulvestrant
Participants will receive doublet combination treatment with atezolizumab plus entinostat until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody · Drug: Entinostat
Participants will receive doublet combination treatment with atezolizumab plus fulvestrant until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody · Drug: Fulvestrant
Participants will receive doublet combination treatment with atezolizumab plus ipatasertib until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Prior to enrollment into this arm, the first 6 participants in the study will complete a safety run-in with atezolizumab plus ipatasertib.
Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody · Drug: Ipatasertib
Participants will receive triplet combination treatment with atezolizumab plus ipatasertib plus fulvestrant until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Prior to enrollment into this arm, the first 6 participants in the study will complete a safety run-in with atezolizumab plus ipatasertib.
Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody · Drug: Fulvestrant · Drug: Ipatasertib
Those who progress or experience unacceptable toxicity during treatment in Stage 1 may be eligible to enter Stage 2. Participants will receive triplet combination therapy with atezolizumab plus bevacizumab plus one of three endocrine therapies (fulvestrant, exemestane, or tamoxifen) selected by the physician. Treatment in Stage 2 will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody · Drug: Bevacizumab · Drug: Exemestane · Drug: Fulvestrant · Drug: Tamoxifen
For experimental combination arms that demonstrate clinical activity during the preliminary phase, the Sponsor may open enrollment into a separate mandatory on-treatment biopsy cohort for that combination.
Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody · Drug: Entinostat · Drug: Fulvestrant · Drug: Ipatasertib · Drug: Abemaciclib
Participants will receive triplet combination treatment with atezolizumab plus abemaciclib plus fulvestrant until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody · Drug: Fulvestrant · Drug: Abemaciclib
Atezolizumab will be given as 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle. This regimen will apply to all arms except when given with entinostat in Stage 1, or exemestane or tamoxifen in Stage 2, in which atezolizumab will be given as 1200 mg via IV infusion on Day 1 of each 21-day cycle.
Also known as: Tecentriq
Bevacizumab will be given as 10 milligrams per kilogram (mg/kg) via IV infusion on Days 1 and 15 of each 28-day cycle in the regimen containing fulvestrant. When given with exemestane or tamoxifen, bevacizumab will be given as 15 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Also known as: Avastin
Entinostat will be given as 5 mg orally once a week on Days 1, 8 and 15 of each 21-day cycle.
Exemestane will be given as 25 mg orally QD in each 21-day cycle.
Fulvestrant will be given as 500 mg intramuscularly on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle.
Ipatasertib will be given as 400 mg orally QD on Days 1-21 of each 28-day cycle.
Tamoxifen will be given as 20 mg orally QD in each 21-day cycle.
Abemaciclib will be given as 150mg twice daily during each 28-day cycle.
Stage 1: Percentage of Participants With Objective Response
Objective response rate (ORR) was defined as the percentage of participants with an objective response of complete response (CR) or partial response (PR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR was defined as the disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) that have a reduction in short axis to \< 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. Participants with missing or no response assessments were classified as non-responders. Percentages have been rounded off to the nearest whole number.
Time frame: Up to 50.4 months
Stage 1: Progression-free Survival (PFS)
PFS was defined as the time from randomization to the date of the first recorded occurrence of PD or death from any cause (whichever occurred first) in Stage 1, as determined by the investigator according to RECIST v1.1. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum in the study including baseline in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥ 5 mm. Participants who did not have documented PD or death, PFS was censored at the day of the last tumor assessment. The Kaplan-Meier method was used to estimate the median for PFS.
Time frame: From randomization to the first occurrence of PD or death (up to 51.9 months)
Stage 1: Clinical Benefit Rate (CBR)
CBR was defined as the percentage of participants with stable disease (SD) ≥ 24 weeks or with confirmed CR or PR, as determined by the investigator according to RECIST v1.1. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. CR was defined as the disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥ 5 mm. Percentages have been rounded off to the nearest whole number.
Time frame: Up to 51.9 months
Stage 1: Overall Survival (OS)
OS was defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. The Kaplan-Meier method was used to estimate the median for OS.
Time frame: From randomization to death (up to 62.2 months)
Stage 1: Percentage of Participants Event-free for OS at Month 18
OS was defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. The Kaplan-Meier approach was used to estimate the percentage of participants who were event-free for OS at Month 18. Percentages have been rounded off to the nearest whole number.
Time frame: At Month 18
Stage 1: Duration of Response (DOR)
DOR was defined as the time from the first occurrence of a documented objective response (CR or PR) to the first date of recorded PD or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum in study including baseline in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥ 5 mm. Participants who did not have documented PD or death, DOR was censored at the day of the last tumor assessment. The Kaplan-Meier method was used to estimate the median for DOR.
Time frame: From first occurrence of a documented OR to the first date of recorded PD or death (up to 50.4 months)
Stages 1 and 2: Number of Participants With Adverse Events (AEs)
An AE was any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE = serious adverse events; AESIs = adverse events of special interest.
Time frame: From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months)
Stage 1: Plasma Concentration of Entinostat
Time frame: Predose on Day 1 of Cycles 1 and 2; 2-4 hours postdose on Day 1 Cycle 1 (Cycle length = 21 days)
Stage 1: Plasma Concentration of Abemaciclib
Time frame: Predose on Day 1 of Cycles 1, 2 and 3, and on Day 15 Cycle 1; 4-8 hours postdose on Day 1 Cycle 1 (Cycle length = 28 days)
Stage 1: Plasma Concentration of Ipatasertib
Time frame: Predose and Postdose at 1 Hour, 2 Hour, 4 Hour, and 6 Hour on Day 15 Cycle 1; Post dose at 1-3 Hour on Day 15 Cycle 3 (Cycle length = 28 days)
Stage 1: Plasma Concentration of Fulvestrant
Time frame: Predose on Day 1 of Cycle 2 and Cycle 3 (Cycle length = 28 days)
Stage 2: Plasma Concentration of Fulvestrant
Nominal time restarted to 0 at Stage 2. PK data for Stage was analyzed and reported for the subgroups \[crossover arms (Stage 1 to Stage 2)\] only.
Time frame: Predose on Day 1 of Cycles 2 and 3 (Cycle length = 21 days)
Stage 2: Serum Concentration of Atezolizumab
Nominal time restarted to 0 at Stage 2; RO5541267 = atezolizumab. PK data for Stage was analyzed and reported for the subgroups \[crossover arms (Stage 1 to Stage 2)\] only.
Time frame: Predose on Day 1 of Cycles 1, 2, 3, 4, 8 and 12; 30 minutes (mins) postdose on Day 1 Cycle 1; postdose on Day 120 and Treatment Discontinuation Visit (Cycle length = 21 days)
Stage 2: Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Participants who received atezolizumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following atezolizumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants were considered to be treatment-emergent ADA-negative if they were ADA-negative or were missing data at baseline and all post-baseline samples were negative, or if they were ADA-positive at baseline but did not have any post-baseline samples with a titer that was at least 0.60 t.u. greater than the titer of the baseline sample (treatment unaffected). Participants with a positive post-baseline sample has been reported here.
Time frame: Post-baseline (up to approximately 134 days)
A total of 144 participants with inoperable locally advanced or metastatic hormone receptor-positive (HR+) human epidermal growth factor receptor 2 negative (HER2-) breast cancer took part in the study at 26 investigative sites across the United States of America and South Korea from 22 December 2017 to 26 September 2024. The study is considered "Completed" because all the pre-planned study activities and analyses have been performed.
| Milestone | Fulvestrant Control | Stage 1: Fulvestrant + Atezolizumab | Stage 1: Fulvestrant + Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Entinostat | Stage 1: Fulvestrant + Atezolizumab + Abemaciclib | Stage 2: Atezolizumab + Bevacizumab + Fulvestrant | Stage 2: Atezolizumab + Bevacizumab + Exemestane | Stage 2: Atezolizumab + Bevacizumab + Tamoxifen |
|---|---|---|---|---|---|---|---|---|---|
| Started | 25 | 31 | 27 | 6 | 15 | 40 | 0 | 0 | 0 |
| Safety-evaluable (se) population | 20 | 30 | 26 | 6 | 15 | 39 | 0 | 0 | 0 |
| Completed | 18 | 28 | 24 | 6 | 15 | 33 | 0 | 0 | 0 |
| Not completed | 7 | 3 | 3 | 0 | 0 | 7 | 0 | 0 | 0 |
| Withdrew: Death | 2 | 1 | 0 | 0 | 0 | 3 | 0 | 0 | 0 |
| Withdrew: Study ended by sponsor | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 5 | 1 | 2 | 0 | 0 | 2 | 0 | 0 | 0 |
| Withdrew: Reason not specified | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Physician decision | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Fulvestrant Control | Stage 1: Fulvestrant + Atezolizumab | Stage 1: Fulvestrant + Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Entinostat | Stage 1: Fulvestrant + Atezolizumab + Abemaciclib | Stage 2: Atezolizumab + Bevacizumab + Fulvestrant | Stage 2: Atezolizumab + Bevacizumab + Exemestane | Stage 2: Atezolizumab + Bevacizumab + Tamoxifen |
|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 13 | 4 | 3 |
| Se population | 0 | 0 | 0 | 0 | 0 | 0 | 13 | 4 | 3 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 11 | 3 | 3 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Progressive disease | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
| Milestone | Fulvestrant Control | Stage 1: Fulvestrant + Atezolizumab | Stage 1: Fulvestrant + Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Entinostat | Stage 1: Fulvestrant + Atezolizumab + Abemaciclib | Stage 2: Atezolizumab + Bevacizumab + Fulvestrant | Stage 2: Atezolizumab + Bevacizumab + Exemestane | Stage 2: Atezolizumab + Bevacizumab + Tamoxifen |
|---|---|---|---|---|---|---|---|---|---|
| Started | 15 | 25 | 20 | 3 | 9 | 32 | 11 | 3 | 3 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 15 | 25 | 20 | 3 | 9 | 32 | 11 | 3 | 3 |
| Withdrew: Death | 10 | 14 | 15 | 3 | 6 | 18 | 11 | 1 | 3 |
| Withdrew: Study ended by sponsor | 4 | 9 | 3 | 0 | 0 | 13 | 0 | 2 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 1 | 0 | 2 | 1 | 0 | 0 | 0 |
Objective response rate (ORR) was defined as the percentage of participants with an objective response of complete response (CR) or partial response (PR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR was defined as the disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) that have a reduction in short axis to \< 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. Participants with missing or no response assessments were classified as non-responders. Percentages have been rounded off to the nearest whole number.
| percentage of participants | Fulvestrant Control | Stage 1: Fulvestrant + Atezolizumab | Stage 1: Fulvestrant + Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Entinostat | Stage 1: Fulvestrant + Atezolizumab + Abemaciclib |
|---|---|---|---|---|---|---|
| Stage 1: Percentage of Participants With Objective Response | 10.0 (1.23 to 31.70) | 10.0 (2.11 to 26.53) | 26.9 (11.57 to 47.79) | 16.7 (0.42 to 64.12) | 6.7 (0.17 to 31.95) | 26.3 (13.40 to 43.10) |
PFS was defined as the time from randomization to the date of the first recorded occurrence of PD or death from any cause (whichever occurred first) in Stage 1, as determined by the investigator according to RECIST v1.1. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum in the study including baseline in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥ 5 mm. Participants who did not have documented PD or death, PFS was censored at the day of the last tumor assessment. The Kaplan-Meier method was used to estimate the median for PFS.
| months | Fulvestrant Control | Stage 1: Fulvestrant + Atezolizumab | Stage 1: Fulvestrant + Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Entinostat | Stage 1: Fulvestrant + Atezolizumab + Abemaciclib |
|---|---|---|---|---|---|---|
| Stage 1: Progression-free Survival (PFS) | 1.95 (1.45 to 4.93) | 3.15 (1.51 to 7.79) | 5.86 (1.64 to 11.24) | 2.28 (1.41 to NA) | 1.82 (1.48 to 3.84) | 6.28 (5.13 to 11.73) |
CBR was defined as the percentage of participants with stable disease (SD) ≥ 24 weeks or with confirmed CR or PR, as determined by the investigator according to RECIST v1.1. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. CR was defined as the disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥ 5 mm. Percentages have been rounded off to the nearest whole number.
| percentage of participants | Fulvestrant Control | Stage 1: Fulvestrant + Atezolizumab | Stage 1: Fulvestrant + Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Entinostat | Stage 1: Fulvestrant + Atezolizumab + Abemaciclib |
|---|---|---|---|---|---|---|
| Stage 1: Clinical Benefit Rate (CBR) | 15.0 (3.21 to 37.89) | 26.7 (12.28 to 45.89) | 42.3 (23.35 to 63.08) | 16.7 (0.42 to 64.12) | 6.7 (0.17 to 31.95) | 42.1 (26.31 to 59.18) |
OS was defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. The Kaplan-Meier method was used to estimate the median for OS.
| months | Fulvestrant Control | Stage 1: Fulvestrant + Atezolizumab | Stage 1: Fulvestrant + Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Entinostat | Stage 1: Fulvestrant + Atezolizumab + Abemaciclib |
|---|---|---|---|---|---|---|
| Stage 1: Overall Survival (OS) | 26.02 (9.13 to 35.09) | 26.48 (15.87 to 46.46) | 26.91 (20.93 to 47.41) | 10.91 (5.59 to NA) | 23.10 (15.24 to NA) | 26.71 (22.60 to 36.17) |
OS was defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. The Kaplan-Meier approach was used to estimate the percentage of participants who were event-free for OS at Month 18. Percentages have been rounded off to the nearest whole number.
| percentage of participants | Fulvestrant Control | Stage 1: Fulvestrant + Atezolizumab | Stage 1: Fulvestrant + Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Entinostat | Stage 1: Fulvestrant + Atezolizumab + Abemaciclib |
|---|---|---|---|---|---|---|
| Stage 1: Percentage of Participants Event-free for OS at Month 18 | 63.91 (40.55 to 87.26) | 63.16 (43.97 to 82.35) | 81.61 (65.22 to 98.00) | NA (NA to NA) | 75.76 (45.17 to 100.00) | 74.40 (59.97 to 88.84) |
DOR was defined as the time from the first occurrence of a documented objective response (CR or PR) to the first date of recorded PD or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum in study including baseline in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥ 5 mm. Participants who did not have documented PD or death, DOR was censored at the day of the last tumor assessment. The Kaplan-Meier method was used to estimate the median for DOR.
| months | Fulvestrant Control | Stage 1: Fulvestrant + Atezolizumab | Stage 1: Fulvestrant + Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Entinostat | Stage 1: Fulvestrant + Atezolizumab + Abemaciclib |
|---|---|---|---|---|---|---|
| Stage 1: Duration of Response (DOR) | 13.03 (10.15 to NA) | 5.88 (3.29 to NA) | 11.07 (7.85 to 20.70) | 4.40 (NA to NA) | 2.46 (NA to NA) | 13.36 (8.87 to 17.02) |
An AE was any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE = serious adverse events; AESIs = adverse events of special interest.
| Participants | Fulvestrant Control | Stage 1: Fulvestrant + Atezolizumab | Stage 1: Fulvestrant + Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Entinostat | Stage 1: Fulvestrant + Atezolizumab + Abemaciclib | Stage 2: Atezolizumab + Bevacizumab + Fulvestrant | Stage 2: Atezolizumab + Bevacizumab + Exemestane | Stage 2: Atezolizumab + Bevacizumab + Tamoxifen |
|---|---|---|---|---|---|---|---|---|---|
| Stages 1 and 2: Number of Participants With Adverse Events (AEs) | 18 | 28 | 26 | 6 | 15 | 39 | 12 | 3 | 3 |
| nanograms per milliliter (ng/mL) | Stage 1: Atezolizumab + Entinostat |
|---|---|
| Predose on Cycle 1 Day 1 | NA ± NA |
| 2-4 Hrs Postdose on Cycle 1 Day 1 | 22.3 ± 91.0 |
| Predose on Cycle 2 Day 1 | 2.12 ± 60.3 |
| micrograms per milliliter (µg/mL) | Stage 1: Fulvestrant + Atezolizumab + Abemaciclib |
|---|---|
| Predose on Cycle 1 Day 1 | 0.00417 ± 50.3 |
| 4-8 Hour Postdose on Cycle 1 Day 1 | 0.0581 ± 170.0 |
| Predose on Cycle 1 Day 15 | 0.319 ± 57.4 |
| Predose on Cycle 2 Day 1 | 0.108 ± 573.7 |
| Predose on Cycle 3 Day 1 | 0.144 ± 177.7 |
| µg/mL | Stage 1: Fulv + Atezo + Ipat | Stage 1: Atezo + Ipat |
|---|---|---|
| Predose on Cycle 1 Day 15 | 0.0353 ± 248.9 | 0.0105 ± 10113.9 |
| 1 Hour Postdose on Cycle 1 Day 15 | 0.154 ± 185.0 | 0.203 ± 38.5 |
| 2 Hour Postdose on Cycle 1 Day 15 | 0.447 ± 53.7 | 0.398 ± NA |
| 4 Hour Postdose on Cycle 1 Day 15 | 0.273 ± 45.9 | 0.303 ± NA |
| 6 Hour Postdose on Cycle 1 Day 15 | 0.203 ± 45.4 | 0.227 ± NA |
| 1-3 Hour Postdose on Cycle 3 Day 15 | 0.576 ± 25.9 | 0.0664 ± NA |
| µg/mL | Stage 1: Fulv + Atezo + Abem | Stage 1: Fulve + Atezo | Stage 1: Fulv + Atezo + Ipat |
|---|---|---|---|
| Predose on Cycle 2 Day 1 | 0.0127 ± NA | 0.0136 ± 60.2 | 0.0161 ± 74.3 |
| Predose on Cycle 3 Day 1 | — | 0.0107 ± 40.3 | 0.0121 ± 38.0 |
Nominal time restarted to 0 at Stage 2. PK data for Stage was analyzed and reported for the subgroups \[crossover arms (Stage 1 to Stage 2)\] only.
| µg/mL | Stage 1: Atezo + Entino : Stage 2: Atezo + Beva + Fulv | Stage 1: Fulv Control : Stage 2: Atezo + Beva+ Fulv | Stage 1: Atezo + Ipat : Stage 2: Atezo + Beva + Fulv |
|---|---|---|---|
| Predose on Day 1 Cycle 2 (Stage 2) | 0.0207 ± 14.1 | 0.00938 ± NA | 0.0142 ± 41.2 |
| Predose on Day 1 Cycle 3 (Stage 2) | 0.0121 ± 39.3 | 0.0175 ± NA | 0.0132 ± 10.3 |
Nominal time restarted to 0 at Stage 2; RO5541267 = atezolizumab. PK data for Stage was analyzed and reported for the subgroups \[crossover arms (Stage 1 to Stage 2)\] only.
| µg/mL | Stage 1: Fulv + Atezo + Abem : Stage 2: Atezo + Beva + Fulv | Stage 1: Atezo + Entino : Stage 2: Atezo + Beva + Fulv | Stage 1: Fulv + Atezo : Stage 2: Atezo + Beva + Fulv | Stage 1: Fulv + Atezo : Stage 2: Atezo+ Beva+ Tamo | Stage 1: Fulv + Atezo + Ipat : Stage 2: Atezo + Beva + Exem | Stage 1: Fulv + Atezo+ Ipat : Stage 2: Atezo + Beva + Tamo | Stage 1: Fulv Control : Stage 2 Atezo + Beva + Exem | Stage 1: Fulv Control : Stage 2: Atezo + Beva+ Fulv | Stage 1: Atezo + Ipat : Stage 2: Atezo + Beva + Fulv |
|---|---|---|---|---|---|---|---|---|---|
| Predose on Day 1 Cycle 1 (Stage 2) | 217 ± NA | 128 ± 49.2 | 443 ± NA | 160 ± 209.6 | 277 ± NA | 167 ± NA | NA ± NA | NA ± NA | 16.3 ± 63062.7 |
| 30 mins postdose on Day 1 Cycle 1 (Stage 2) | 617 ± NA | 388 ± 22.3 | 907 ± NA | 725 ± 52.9 | 1030 ± NA | 679 ± NA | 498 ± NA | — | 491 ± 16.3 |
| Predose on Day 1 Cycle 2 (Stage 2) | 202 ± NA | 251 ± 35.8 | 434 ± NA | 211 ± 143.9 | 373 ± NA | 253 ± NA | 141 ± NA | 136 ± NA | 227 ± 65.2 |
| Predose on Day 1 Cycle 3 (Stage 2) | — | 318 ± 8.8 | — | 208 ± 93.2 | 333 ± NA | 284 ± NA | — | 220 ± NA | 274 ± 47.4 |
| Predose on Day 1 Cycle 4 (Stage 2) | — | 302 ± 20.8 | — | 115 ± NA | 341 ± NA | 310 ± NA | — | 238 ± NA | 309 ± 35.2 |
| Predose on Day 1 Cycle 8 (Stage 2) | — | — | — | — | — | — | — | — | 131 ± NA |
| Predose on Day 1 Cycle 12 (Stage 2) | — | — | — | — | — | — | — | — | 182 ± NA |
| Postdose on Day 120 (Stage 2) | — | 27.4 ± NA | — | 30.0 ± NA | — | — | 22.6 ± NA | — | 7.38 ± NA |
| Treatment Discontinuation Visit (Stage 2) | — | 250 ± 18.9 | 450 ± NA | 130 ± NA | — | — | — | 201 ± NA | 169 ± 145.8 |
Participants who received atezolizumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following atezolizumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants were considered to be treatment-emergent ADA-negative if they were ADA-negative or were missing data at baseline and all post-baseline samples were negative, or if they were ADA-positive at baseline but did not have any post-baseline samples with a titer that was at least 0.60 t.u. greater than the titer of the baseline sample (treatment unaffected). Participants with a positive post-baseline sample has been reported here.
| Participants | Stage 2: Atezolizumab + Bevacizumab + Fulvestrant | Stage 2: Atezolizumab + Bevacizumab + Exemestane | Stage 2: Atezolizumab + Bevacizumab + Tamoxifen |
|---|---|---|---|
| Stage 2: Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab | 0 | 0 | 0 |
Collected over From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fulvestrant Control | 12/25 (48%) | 2/20 (10%) | 18/20 (90%) |
| Stage 1: Fulvestrant + Atezolizumab | 16/31 (51.6%) | 3/30 (10%) | 28/30 (93.3%) |
| Stage 1: Fulvestrant + Atezolizumab + Ipatasertib | 15/27 (55.6%) | 12/26 (46.2%) | 25/26 (96.2%) |
| Stage 1: Atezolizumab + Ipatasertib | 3/6 (50%) | 3/6 (50%) | 6/6 (100%) |
| Stage 1: Atezolizumab + Entinostat | 6/15 (40%) | 4/15 (26.7%) | 15/15 (100%) |
| Stage 1: Fulvestrant + Atezolizumab + Abemaciclib | 23/40 (57.5%) | 14/39 (35.9%) | 38/39 (97.4%) |
| Stage 2: Atezolizumab + Bevacizumab + Fulvestrant | 11/13 (84.6%) | 1/13 (7.7%) | 12/13 (92.3%) |
| Stage 2: Atezolizumab + Bevacizumab + Exemestane | 2/4 (50%) | 1/4 (25%) | 3/4 (75%) |
| Stage 2: Atezolizumab + Bevacizumab + Tamoxifen | 3/3 (100%) | 0/3 (0%) | 3/3 (100%) |
| Event | Fulvestrant Control | Stage 1: Fulvestrant + Atezolizumab | Stage 1: Fulvestrant + Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Entinostat | Stage 1: Fulvestrant + Atezolizumab + Abemaciclib | Stage 2: Atezolizumab + Bevacizumab + Fulvestrant | Stage 2: Atezolizumab + Bevacizumab + Exemestane | Stage 2: Atezolizumab + Bevacizumab + Tamoxifen |
|---|---|---|---|---|---|---|---|---|---|
| Rash maculo-papularSkin and subcutaneous tissue disorders | 0/20 | 0/30 | 0/26 | 2/6 | 0/15 | 0/39 | 0/13 | 0/4 | 0/3 |
| Adrenal insufficiencyEndocrine disorders | 0/20 | 0/30 | 0/26 | 0/6 | 0/15 | 0/39 | 0/13 | 1/4 | 0/3 |
| PyrexiaGeneral disorders | 0/20 | 0/30 | 0/26 | 1/6 | 3/15 | 1/39 | 0/13 | 0/4 | 0/3 |
| Pericardial effusionCardiac disorders | 0/20 | 1/30 | 0/26 | 1/6 | 0/15 | 0/39 | 0/13 | 0/4 | 0/3 |
| Abdominal pain upperGastrointestinal disorders | 0/20 | 0/30 | 0/26 | 1/6 | 0/15 | 0/39 | 0/13 | 0/4 | 0/3 |
| DysphagiaGastrointestinal disorders | 0/20 | 0/30 | 0/26 | 1/6 | 0/15 | 0/39 | 0/13 | 0/4 | 0/3 |
| HypertransaminasaemiaHepatobiliary disorders | 0/20 | 0/30 | 0/26 | 1/6 | 0/15 | 0/39 | 0/13 | 0/4 | 0/3 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/20 | 0/30 | 1/26 | 1/6 | 0/15 | 0/39 | 0/13 | 0/4 | 0/3 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 0/20 | 0/30 | 1/26 | 1/6 | 0/15 | 0/39 | 0/13 | 0/4 | 0/3 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 0/20 | 0/30 | 3/26 | 0/6 | 0/15 | 0/39 | 0/13 | 0/4 | 0/3 |
| Event | Fulvestrant Control | Stage 1: Fulvestrant + Atezolizumab | Stage 1: Fulvestrant + Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Entinostat | Stage 1: Fulvestrant + Atezolizumab + Abemaciclib | Stage 2: Atezolizumab + Bevacizumab + Fulvestrant | Stage 2: Atezolizumab + Bevacizumab + Exemestane | Stage 2: Atezolizumab + Bevacizumab + Tamoxifen |
|---|---|---|---|---|---|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 1/20 | 6/30 | 14/26 | 4/6 | 2/15 | 33/39 | 1/13 | 0/4 | 0/3 |
| NauseaGastrointestinal disorders | 4/20 | 8/30 | 14/26 | 4/6 | 5/15 | 17/39 | 5/13 | 0/4 | 0/3 |
| Decreased appetiteMetabolism and nutrition disorders | 2/20 | 4/30 | 5/26 | 4/6 | 4/15 | 13/39 | 1/13 | 0/4 | 0/3 |
| FatigueGeneral disorders | 4/20 | 11/30 | 9/26 | 3/6 | 4/15 | 17/39 | 7/13 | 1/4 | 0/3 |
| RashSkin and subcutaneous tissue disorders | 0/20 | 3/30 | 14/26 | 0/6 | 1/15 | 10/39 | 1/13 | 0/4 | 0/3 |
| ConstipationGastrointestinal disorders | 3/20 | 7/30 | 12/26 | 3/6 | 1/15 | 4/39 | 1/13 | 0/4 | 0/3 |
| VomitingGastrointestinal disorders | 0/20 | 3/30 | 7/26 | 3/6 | 4/15 | 12/39 | 0/13 | 0/4 | 0/3 |
| DizzinessNervous system disorders | 3/20 | 3/30 | 2/26 | 3/6 | 3/15 | 3/39 | 0/13 | 1/4 | 0/3 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/20 | 7/30 | 7/26 | 3/6 | 4/15 | 3/39 | 1/13 | 1/4 | 0/3 |
| HypertensionVascular disorders | 0/20 | 1/30 | 2/26 | 0/6 | 0/15 | 1/39 | 6/13 | 1/4 | 1/3 |
Randomized population included all participants enrolled, regardless if treatment was received.
| Age, Categorical(Participants) | Fulvestrant Control | Stage 1: Fulvestrant + Atezolizumab | Stage 1: Fulvestrant + Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Entinostat | Stage 1: Fulvestrant + Atezolizumab + Abemaciclib | Stage 2: Atezolizumab + Bevacizumab + Fulvestrant | Stage 2: Atezolizumab + Bevacizumab + Exemestane | Stage 2: Atezolizumab + Bevacizumab + Tamoxifen | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1 — <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage 1 — Between 18 and 65 years | 21 | 23 | 22 | 5 | 12 | 28 | 0 | 0 | 0 | 111 |
| Stage 1 — >=65 years | 4 | 8 | 5 | 1 | 3 | 12 | 0 | 0 | 0 | 33 |
| Stage 2 — <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage 2 — Between 18 and 65 years | 0 | 0 | 0 | 0 | 0 | 0 | 10 | 3 | 1 | 14 |
| Stage 2 — >=65 years | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 1 | 2 | 6 |
| Sex: Female, Male(Participants) | Fulvestrant Control | Stage 1: Fulvestrant + Atezolizumab | Stage 1: Fulvestrant + Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Entinostat | Stage 1: Fulvestrant + Atezolizumab + Abemaciclib | Stage 2: Atezolizumab + Bevacizumab + Fulvestrant | Stage 2: Atezolizumab + Bevacizumab + Exemestane | Stage 2: Atezolizumab + Bevacizumab + Tamoxifen | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1 — Female | 25 | 31 | 27 | 6 | 15 | 40 | 0 | 0 | 0 | 144 |
| Stage 1 — Male | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage 2 — Female | 0 | 0 | 0 | 0 | 0 | 0 | 13 | 4 | 3 | 20 |
| Stage 2 — Male | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Fulvestrant Control | Stage 1: Fulvestrant + Atezolizumab | Stage 1: Fulvestrant + Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Entinostat | Stage 1: Fulvestrant + Atezolizumab + Abemaciclib | Stage 2: Atezolizumab + Bevacizumab + Fulvestrant | Stage 2: Atezolizumab + Bevacizumab + Exemestane | Stage 2: Atezolizumab + Bevacizumab + Tamoxifen | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1 — Hispanic or Latino | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 3 |
| Stage 1 — Not Hispanic or Latino | 23 | 28 | 25 | 6 | 14 | 40 | 0 | 0 | 0 | 136 |
| Stage 1 — Unknown or Not Reported | 1 | 2 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 5 |
| Stage 2 — Hispanic or Latino | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage 2 — Not Hispanic or Latino | 0 | 0 | 0 | 0 | 0 | 0 | 13 | 3 | 3 | 19 |
| Stage 2 — Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Fulvestrant Control | Stage 1: Fulvestrant + Atezolizumab | Stage 1: Fulvestrant + Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Ipatasertib | Stage 1: Atezolizumab + Entinostat | Stage 1: Fulvestrant + Atezolizumab + Abemaciclib | Stage 2: Atezolizumab + Bevacizumab + Fulvestrant | Stage 2: Atezolizumab + Bevacizumab + Exemestane | Stage 2: Atezolizumab + Bevacizumab + Tamoxifen | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1 — American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage 1 — Asian | 8 | 10 | 11 | 0 | 5 | 15 | 0 | 0 | 0 | 49 |
| Stage 1 — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage 1 — Black or African American | 1 | 3 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 7 |
| Stage 1 — White | 12 | 16 | 12 | 6 | 9 | 24 | 0 | 0 | 0 | 79 |
| Stage 1 — More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage 1 — Unknown or Not Reported | 4 | 2 | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 9 |
| Stage 2 — American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage 2 — Asian | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 2 |
| Stage 2 — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage 2 — Black or African American | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage 2 — White | 0 | 0 | 0 | 0 | 0 | 0 | 12 | 0 | 3 | 15 |
| Stage 2 — More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage 2 — Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 3 |
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Studies of the drugs tested here: Bevacizumab · Entinostat · Ipatasertib · Tamoxifen · Abemaciclib