A Phase 2 interventional study of ATEZOLIZUMAB and PERTUZUMAB in HER2-positive Metastatic Breast Cancer and Central Nervous System Metastases, sponsored by Nancy Lin, MD. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Nancy Lin, MD · Phase 2, Interventional, and Treatment
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Among 39 studies testing atezolizumab in Breast Neoplasms — 7 open to participants now, 15 under way, 2 of them phase 3. atezolizumab · Breast Neoplasms.
Among the 39 studies testing atezolizumab in Breast Neoplasms, this one is the 31st largest by enrollment, is one of 6 that started in 2018, is one of 24 in phase 2, and was the 13th registered.
14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.
Browse Breast Neoplasms studies →7 of the 39 studies testing atezolizumab in Breast Neoplasms are open now, in 6 countries. Recruiting first, the newest first:
European Institute of Oncology · Sites in Italy
Ages 18+
Japan Breast Cancer Research Group · Sites in Japan
Ages 18+
German Cancer Research Center · Sites in Germany
Ages 18+
University of Florida · Sites in United States
Ages 18–99
Samsung Medical Center · Sites in Korea, Republic of
Ages 19+
By country, each count listing its studies:
atezolizumab: first FDA approval 2016 (TECENTRIQ), first EMA approval 2017. What it is approved for, and how studies give it, is on its page →
Of the 2,399 Breast Neoplasms studies recruiting now, 1,570 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, atezolizumab is the treatment under test here. Read study by study →
39 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 27 · Phase 3 7
First in 2013; this study’s year is marked. 6 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 19 is below the median of 72 across 10,903 interventional studies indexed under Breast Neoplasms.
Median enrollment 67 across the 39 interventional studies. Of the 21 that completed or were terminated, 11 (52%) have results posted.
This tab as a report to print or save as PDF → With an account.
7 of 39 have an industry lead sponsor. The 10 most frequent:
Nancy Lin, MD is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Nancy Lin, MD has 6 studies filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
7 of the studies testing atezolizumab in Breast Neoplasms that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03595592Phase 3Fondazione MichelangeloNeoadjuvant Treatment of HER2 Positive Early High-risk and Locally Advanced Breast Cancer | 2026-12-15 |
| NCT04873362Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy | 2027-03-31 |
| NCT05000294University of FloridaAtezolizumab Plus Tivozanib in Immunologically Cold Tumor Types | 2026-12 |
| NCT03125928Fox Chase Cancer CenterClinical Trial of Atezolizumab With Paclitaxel, Trastuzumab, and Pertuzumab in Patients With Metastatic HER-2 Positive Breast Cancer | 2026-12 |
| NCT06690840European Institute of OncologyAtezolizumab and Chemotherapy Treatment as T-cell Activators in Metastatic Triple Negative Breast Cancer Patients | 2026-12-15 |
Add all 7 to your calendar (.ics) → With an account.
Among the 39 studies testing atezolizumab in Breast Neoplasms, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This research study is studying a drug called atezolizumab as a possible treatment HER2-positive metastatic breast cancer (MBC) that has spread to the brain.
The names of the study drugs involved in this study are:
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. It also means that the FDA (U.S. Food and Drug Administration) has not approved the combination of atezolizumab, trastuzumab, and pertuzumab for use in humans. The FDA has not approved atezolizumab for this specific disease but it has been approved for other uses.
In this research study, investigators are looking to see how well the cancer responds to the combination of atezolizumab in combination with pertuzumab and trastuzumab.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- Eligibility will be assessed as part of the screening procedures for all patients.
Unequivocal evidence of new and/or progressive brain metastases, and at least one of the following scenarios:
Participants must have normal organ and marrow function as defined below:
Exclusion Criteria:
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 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.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
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 planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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 C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
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.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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 C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive the following treatment: * Atezolizumab (IV) every 3 weeks (q3w)\] * Pertuzumab (loading dose ), followed q3w thereafter by a predetermined dose in the protocol via IV) * High-dose Trastuzumab weekly for the first 24 weeks, and thereafter trastuzumab q3w).
Drug: ATEZOLIZUMAB · Drug: PERTUZUMAB · Drug: TRASTUZUMAB
(IV) every 3 weeks
Also known as: Tecentriq
Loading dose, followed every 3 weeks thereafter by a predetermined dose in the protocol via IV
Also known as: Perjeta
Predetermined dose per protocol via IV, weekly for 24 weeks and after every 3 weeks
Also known as: Herceptin
Confirmed Overall Response Rate in CNS
The proportion of patients who had confirmed complete response or confirmed partial response, assessed using neuro-oncology-brain metastases (RANO-BM) criteria. RANO-BM assess the response of brain metastases to treatment, using MRI scan. There are four categories as results: Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD), which is separately defined as disappearance of all target lesions, at least a 30% decrease in the sum of the diameters of target lesions, neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as progressive disease (PD) and at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest) or the appearance of one or more new lesions.
Time frame: Participants were evaluated for response every 6 weeks for the first 24 weeks and then every 9 weeks thereafter, through study completion, an average of 24 weeks in the real study data
Objective Non-CNS Response Rates
The proportion of patients who had confirmed complete response or partial response, according to response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria. RECIST is used to assess the response of solid tumors to treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.
Time frame: Participants were evaluated for response every 6 weeks for the first 24 weeks and then every 9 weeks thereafter, through study completion, an average of 24 weeks in the real study data
Clinical Benefit Rate in CNS at 18 Weeks
The proportion of patients who had stable disease, confirmed partial response or complete response, respectively, \>=18 weeks, according to RANO-BM criteria
Time frame: Participants were evaluated for response every 6 weeks for the first 24 weeks and then every 9 weeks thereafter, through study completion, an average of 24 weeks in the real study data
Patient Reported Outcomes by MDASI-BT Stratified by CBR at 18 Weeks
Evaluated by M.D. Anderson Symptom Inventory Brain Tumor (MDASI-BT). MDASI-BT assess 13 symptom items and 6 interference items from the core MDAST as well as 9 symptoms specific to brain tumors, and generate Symptom Severity Score (SSS) and Symptom Interference Score (SIS) separately. The scale of the scores are in a range of 0 to 10, where 0 represents "not present" or "not severe," and 10 represents "as bad as you can imagine" or "most severe." A higher score indicates a higher level of symptom severity. Mean of the scores are reported across groups with and without CBR at 18 weeks and in baseline, week 9 and week 24.
Time frame: 24 weeks
Patient Reported Outcomes by EQ-5D Stratified by CBR at 18 Weeks
Evaluated by EuroQol Five Dimension Questionnaire (EQ-5D) evaluations assessments to assess the general health status of patients enrolled in the study. EQ-5D scores are assessed with five dimensions with the range of 0 to 5, and a higher score indicates worse health. Mean of the scores are reported across groups with and without CBR at 18 weeks and in baseline, week 9 and week 24.
Time frame: 24 weeks
Investigator-Assessed Neurological Evaluation (NANO) Stratified by CBR at 18 Weeks
Evaluated by physician assessed Neurological Assessment in Neuro-Oncology (NANO) scale. The NANO scale is a quantifiable evaluation of 9 relevant neurologic domains based on direct observation and testing conducted during visits. The score defines overall response criteria and is with the range of 0 to 4. Higher score means worse response to the treatment. Mean of the scores are reported across groups with and without CBR at 18 weeks and in baseline, week 9 and week 24.
Time frame: 24 weeks
Clinical Benefit Rate in CNS at 24 Weeks
The proportion of patients who had stable disease, confirmed partial response or complete response, respectively, \>=24 weeks, according to RANO-BM criteria
Time frame: Participants were evaluated for response every 6 weeks for the first 24 weeks and then every 9 weeks thereafter, through study completion, an average of 24 weeks in the real study data
| Milestone | ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB |
|---|---|
| Started | 19 |
| Completed | 19 |
| Not completed | 0 |
The proportion of patients who had confirmed complete response or confirmed partial response, assessed using neuro-oncology-brain metastases (RANO-BM) criteria. RANO-BM assess the response of brain metastases to treatment, using MRI scan. There are four categories as results: Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD), which is separately defined as disappearance of all target lesions, at least a 30% decrease in the sum of the diameters of target lesions, neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as progressive disease (PD) and at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest) or the appearance of one or more new lesions.
| Participants | ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB |
|---|---|
| Confirmed Overall Response Rate in CNS | 2 |
The proportion of patients who had confirmed complete response or partial response, according to response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria. RECIST is used to assess the response of solid tumors to treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.
| Participants | ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB |
|---|---|
| Objective Non-CNS Response Rates | 1 |
The proportion of patients who had stable disease, confirmed partial response or complete response, respectively, \>=18 weeks, according to RANO-BM criteria
| Participants | ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB |
|---|---|
| Clinical Benefit Rate in CNS at 18 Weeks | 8 |
Evaluated by M.D. Anderson Symptom Inventory Brain Tumor (MDASI-BT). MDASI-BT assess 13 symptom items and 6 interference items from the core MDAST as well as 9 symptoms specific to brain tumors, and generate Symptom Severity Score (SSS) and Symptom Interference Score (SIS) separately. The scale of the scores are in a range of 0 to 10, where 0 represents "not present" or "not severe," and 10 represents "as bad as you can imagine" or "most severe." A higher score indicates a higher level of symptom severity. Mean of the scores are reported across groups with and without CBR at 18 weeks and in baseline, week 9 and week 24.
| score on a scale | ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB |
|---|---|
| SSS Score for patients with CBR at 18 weeks at Baseline | 1.8 ± 1.2 |
| SSS Score for patients with CBR at 18 weeks at Week 9 | 1.5 ± 0.9 |
| SSS Score for patients with CBR at 18 weeks at Week 24 | 1.7 ± 1.3 |
| SSS Score for patients without CBR at 18 weeks at Baseline | 1.9 ± 1.2 |
| SSS Score for patients without CBR at 18 weeks at Week 9 | 1.9 ± 1.1 |
| SSS Score for patients without CBR at 18 weeks at Week 24 | 2.5 ± 1.4 |
| SIS Score for patients with CBR at 18 weeks at Baseline | 4.0 ± 2.3 |
| SIS Score for patients with CBR at 18 weeks at Week 9 | 2.8 ± 2.6 |
| SIS Score for patients with CBR at 18 weeks at Week 24 | 2.6 ± 3.4 |
| SIS Score for patients without CBR at 18 weeks at Baseline | 2.2 ± 2.1 |
| SIS Score for patients without CBR at 18 weeks at Week 9 | 2.4 ± 2.4 |
| SIS Score for patients without CBR at 18 weeks at Week 24 | 4.2 ± 2.9 |
Evaluated by EuroQol Five Dimension Questionnaire (EQ-5D) evaluations assessments to assess the general health status of patients enrolled in the study. EQ-5D scores are assessed with five dimensions with the range of 0 to 5, and a higher score indicates worse health. Mean of the scores are reported across groups with and without CBR at 18 weeks and in baseline, week 9 and week 24.
| units on a scale | ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB |
|---|---|
| Patients with CBR at 18 weeks at Baseline | 0.7 ± 0.5 |
| Patients with CBR at 18 weeks at Week 9 | 0.5 ± 0.4 |
| Patients with CBR at 18 weeks at Week 24 | 0.7 ± 0.9 |
| Patients without CBR at 18 weeks at Baseline | 0.9 ± 0.7 |
| Patients without CBR at 18 weeks at Week 9 | 0.8 ± 0.4 |
| Patients without CBR at 18 weeks at Week 24 | 1.4 ± 0.7 |
Evaluated by physician assessed Neurological Assessment in Neuro-Oncology (NANO) scale. The NANO scale is a quantifiable evaluation of 9 relevant neurologic domains based on direct observation and testing conducted during visits. The score defines overall response criteria and is with the range of 0 to 4. Higher score means worse response to the treatment. Mean of the scores are reported across groups with and without CBR at 18 weeks and in baseline, week 9 and week 24.
| units on a scale | ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB |
|---|---|
| Patients with CBR at 18 weeks at Baseline | 0.03 ± 0.08 |
| Patients with CBR at 18 weeks at Week 9 | 0.1 ± 0.13 |
| Patients with CBR at 18 weeks at Week 24 | 0.17 ± 0.27 |
| Patients without CBR at 18 weeks at Baseline | 0.1 ± 0.14 |
| Patients without CBR at 18 weeks at Week 9 | 0.18 ± 0.24 |
| Patients without CBR at 18 weeks at Week 24 | 0.39 ± 0.27 |
The proportion of patients who had stable disease, confirmed partial response or complete response, respectively, \>=24 weeks, according to RANO-BM criteria
| Participants | ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB |
|---|---|
| Clinical Benefit Rate in CNS at 24 Weeks | 6 |
Collected over All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB | 1/19 (5.3%) | 10/19 (52.6%) | 19/19 (100%) |
| Event | ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB |
|---|---|
| AnemiaBlood and lymphatic system disorders | 3/19 |
| DiarrheaGastrointestinal disorders | 2/19 |
| Lymphocyte count decreasedInvestigations | 2/19 |
| HyperglycemiaMetabolism and nutrition disorders | 2/19 |
| Edema cerebralNervous system disorders | 2/19 |
| HypertensionVascular disorders | 2/19 |
| Heart failureCardiac disorders | 1/19 |
| Abdominal painGastrointestinal disorders | 1/19 |
| OtherGeneral disorders | 1/19 |
| FatigueGeneral disorders | 1/19 |
| Event | ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB |
|---|---|
| FatigueGeneral disorders | 16/19 |
| DiarrheaGastrointestinal disorders | 11/19 |
| HeadacheNervous system disorders | 11/19 |
| NauseaGastrointestinal disorders | 10/19 |
| Aspartate aminotransferase increasedInvestigations | 9/19 |
| HypertensionVascular disorders | 9/19 |
| HyperglycemiaMetabolism and nutrition disorders | 8/19 |
| ConstipationGastrointestinal disorders | 7/19 |
| Lymphocyte count decreasedInvestigations | 7/19 |
| CoughRespiratory, thoracic and mediastinal disorders | 7/19 |
| Age, Continuous(years) | ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB |
|---|---|
| Median | 50 (35 to 71) |
| Sex: Female, Male(Participants) | ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB |
|---|---|
| Female | 19 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 19 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 17 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| ECOG PS(Participants) | ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB |
|---|---|
| 0 | 12 |
| 1 | 7 |
| Stage at Initial Diagnosis(Participants) | ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB |
|---|---|
| I | 1 |
| II | 5 |
| III | 5 |
| IV | 5 |
| Not IV, but otherwise unknown | 3 |
| Hormone Receptor Status of Primary Tumor(Participants) | ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB |
|---|---|
| ER and PR positive | 7 |
| ER positive/PR negative | 2 |
| ER negative/PR positive | 1 |
| ER and PR negative | 9 |
| Hormone Receptor Status of Metastatic Tumor(Participants) | ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB |
|---|---|
| ER and PR positive | 1 |
| ER positive/PR negative | 2 |
| ER negative/PR positive | 1 |
| ER and PR negative | 10 |
| Unknown | 5 |
8 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2018 to primary completion in May 2020, 23 months.
Results were first posted in May 2024, 3 years 11 months after primary completion.
Of 1,070 non-industry phase 2 interventional studies under Breast Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 89. This study's 23 months is below that.
Counting every sponsor, half of 1,302 studies reached it within 51 months; a quarter within 30 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Atezolizumab
Nancy Lin, MD