A Phase 2 interventional study of Aromatase Inhibitor and Laboratory Biomarker Analysis in Estrogen Receptor and/or Progesterone Receptor Positive, HER2/Neu Negative and Stage IV Breast Cancer AJCC v6 and v7, sponsored by City of Hope Medical Center. Completed at 9 sites in United States. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by City of Hope Medical Center · Phase 2, Interventional, and Treatment
Among 349 studies testing Aromatase inhibitors in Breast Neoplasms — 53 open to participants now, 81 under way, 22 of them phase 3. A drug class: Aromatase inhibitors · Breast Neoplasms.
Among the 349 studies testing Aromatase inhibitors in Breast Neoplasms, this one is the 330th largest by enrollment of the 341 interventional ones that give a count, is one of 13 that started in 2018, is one of 166 in phase 2, and was the 260th registered.
14,829 studies on the registry are indexed under Breast Neoplasms; 3,318 are open to participants now.
Browse Breast Neoplasms studies →53 of the 349 studies testing Aromatase inhibitors in Breast Neoplasms are open now, in 12 countries. Recruiting first, the newest first:
Second Affiliated Hospital, School of Medicine, Zhejiang University · Sites in China
Ages 18–75 · Women only
European Institute of Oncology · Sites in Italy
Ages 18+
Second Affiliated Hospital, School of Medicine, Zhejiang University · Sites in China
Ages 18–75 · Women only
Memorial Sloan Kettering Cancer Center · Sites in United States
Ages 50+ · Women only
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sites in China
Ages 18+ · Women only
By country, each count listing its studies:
A class of medicines: which ones, and the studies of each, are on its page →
Of the 2,398 Breast Neoplasms studies recruiting now, 1,569 (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: 70 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.
349 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 27 · Phase 2 181 · Phase 3 107 · Phase 4 28
First in 1990; this study’s year is marked. 13 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 2 is below the median of 72 across 10,900 interventional studies indexed under Breast Neoplasms.
Median enrollment 112 across the 341 interventional studies. Of the 225 that completed or were terminated, 96 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
79 of 349 have an industry lead sponsor. The 10 most frequent:
City of Hope Medical Center is the lead sponsor of 677 studies on the registry; 181 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 12 (39%) have results posted.
89 studies in Breast Neoplasms by City of Hope Medical Center: 17 open now, 39 under way, 1 of them phase 3. Of 43 finished, 14 (33%) have results posted.
Among the 89 studies in Breast Neoplasms by City of Hope Medical Center, this one is the 67th largest by enrollment of the 76 interventional ones that give a count, is one of 3 that started in 2018, is one of 25 in phase 2, and was the 62nd registered.
City of Hope Medical Center’s Breast Neoplasms studies by the year they started, since 1994.
15 of the studies testing Aromatase inhibitors 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 |
|---|---|
| NCT05780567Phase 3Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer | 2026-12 |
| NCT01953588Phase 3Alliance for Clinical Trials in OncologyFulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery | 2027-04-01 |
| NCT04486911Shengjing HospitalPyrotinib Maleate, CDK4/6 Inhibitor and Letrozole in Combination for Stage II-III TPBC: a Phase II Trial | 2026-12-01 |
| NCT05286437National Cancer Centre, SingaporePhase II Lenvatinib and Pembrolizumab in Endocrine Resistant Breast Cancer With Letrozole | 2026-12-31 |
| NCT07492394Hebei Medical University Fourth HospitalDalpiciclib With or Without Entinostat and Letrozole in HR+/HER2- Early Breast Cancer | 2026-12-31 |
Add all 15 to your calendar (.ics) → With an account.
Among the 349 studies testing Aromatase inhibitors in Breast Neoplasms, from their registry updates:
Among City of Hope Medical Center’s 89 in Breast Neoplasms:
This tab as a report to print or save as PDF → With an account.
This phase IIA trial studies the side effects of ribociclib and aromatase inhibitor and how well they work in treating participants with hormone receptor positive breast cancer that has spread to other places in the body. Ribociclib and aromatase inhibitors may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To estimate the safety and tolerability of the combination of ribociclib and an aromatase inhibitor in adults age 70 or older with hormone receptor positive metastatic breast cancer.
SECONDARY OBJECTIVES:
I. To describe the full toxicity profile including all grades. II. To estimate the rate of worst grades of myelosuppression (neutropenia, leukopenia, thrombocytopenia, and anemia), neutropenic fever, gastrointestinal (GI) side effects (nausea, diarrhea, decreased appetite, vomiting, stomatitis), fatigue, neuropathy, and thromboembolism.
III. To describe rates of dose reductions, dose holds, and hospitalizations. IV. To estimate objective response rate and clinical benefit rate as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) (1.1) criteria.
V. To estimate median progression-free and overall survival.
EXPLORATORY OBJECTIVES:
I. To estimate the rate of adherence to ribociclib. II. To explore factors other than chronologic age that can affect toxicity rates as identified using a cancer-specific geriatric assessment.
III. To describe the results of the Was It Worth It (WIWI) and the results of the Overall Treatment Utility (OTU) Questionnaires.
OUTLINE:
Participants receive ribociclib orally (PO) once daily (QD) on days 1-21 and aromatase inhibitor per treating investigator's discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up at 30 days, then annually thereafter.
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.
Age: >= 70 years at time of enrollment >= 70 to \< 74 years, >= 75 years
* NOTE: A minimum of 20 participants must be >= 75 years. The remaining 20 participants may be >= 70 to \< 74 years OR >= 75 years
Patient must have the following laboratory values within normal limits or corrected to within normal limits with supplement before the first dose of study medication:
Patient with available standard 12-lead (ECG) with the following parameters at screening (defined as the mean of the triplicate ECGs):
Exclusion Criteria:
Patients with central nervous system (CNS) involvement unless they meet ALL the following criteria:
Previously treated brain metastases not needing immediate local therapy
, uncontrolled heart disease and/or cardiac repolarization abnormalities, including any of the following:
Long syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to starting study drug:
Patient is currently receiving or has received systemic corticosteroids =\< 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment
* The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular)
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.
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.
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 that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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).
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.
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.
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.
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.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
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.
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.
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.
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.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
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.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
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.
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.
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.
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.
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.
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.
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.
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.
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.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
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.
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.
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.
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.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
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.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive ribociclib orally PO QD on days 1-21 and aromatase inhibitor per treating investigator's discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Aromatase Inhibitor · Other: Laboratory Biomarker Analysis · Other: Pharmacokinetic Study · Other: Questionnaire Administration · Drug: Ribociclib
Aromatase inhibitor per treating investigator's discretion
Also known as: Androstenedione Aromatase Inhibitor, Estrogen Synthase Inhibitor, Estrogen Synthetase Inhibitor
Correlative studies
Correlative studies
Also known as: PHARMACOKINETIC, PK Study
Ancillary studies
Given PO
Also known as: Kisqali, LEE-011, LEE011
Number of Participants With Grade 2 and Above Toxicities Attributed to Ribociclib
Number of participants with grade 2 and above toxicities attributed (possible, probable or definite) to ribociclib
Time frame: Up to 30 days of last study drug, about 3 years and 3 months
Number of Participants With Dose Reductions
Time frame: Up to 3.5 years
Number of Participants With Dose Delays
Time frame: Up to 3.5 years
Number of Participants With Dose Discontinuations
Time frame: Up to 3.5 years
Objective Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Objective response rate (defined as complete response \[CR\] + partial response \[PR\]) as determined by RECIST criteria Complete Response (CR): Disappearance of all target lesions. Lymph node CR is when the lymph node has decreased to less than 10mm in the short axis. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 3.5 years
Clinical Benefit Rate as Determined by RECIST
Clinical benefit rate (defined as CR+PR+ stable disease) as determined by RECIST Complete Response (CR): Disappearance of all target lesions. Lymph node CR is when the lymph node has decreased to less than 10mm in the short axis. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Time frame: Up to 3.5 years
| Milestone | Treatment (Ribociclib, Aromatase Inhibitor) |
|---|---|
| Started | 2 |
| Completed | 2 |
| Not completed | 0 |
Number of participants with grade 2 and above toxicities attributed (possible, probable or definite) to ribociclib
| Participants | Treatment (Ribociclib, Aromatase Inhibitor) |
|---|---|
| Number of Participants With Grade 2 and Above Toxicities Attributed to Ribociclib | 2 |
| Participants | Treatment (Ribociclib, Aromatase Inhibitor) |
|---|---|
| Number of Participants With Dose Reductions | 2 |
| Participants | Treatment (Ribociclib, Aromatase Inhibitor) |
|---|---|
| Number of Participants With Dose Delays | 2 |
| Participants | Treatment (Ribociclib, Aromatase Inhibitor) |
|---|---|
| Number of Participants With Dose Discontinuations | 2 |
Objective response rate (defined as complete response \[CR\] + partial response \[PR\]) as determined by RECIST criteria Complete Response (CR): Disappearance of all target lesions. Lymph node CR is when the lymph node has decreased to less than 10mm in the short axis. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
| Participants | Treatment (Ribociclib, Aromatase Inhibitor) |
|---|---|
| Objective Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria | 1 |
Clinical benefit rate (defined as CR+PR+ stable disease) as determined by RECIST Complete Response (CR): Disappearance of all target lesions. Lymph node CR is when the lymph node has decreased to less than 10mm in the short axis. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
| Participants | Treatment (Ribociclib, Aromatase Inhibitor) |
|---|---|
| Clinical Benefit Rate as Determined by RECIST | 2 |
Collected over Up to 30 days post cycle, up to 3.5 years total. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Ribociclib, Aromatase Inhibitor) | 1/2 (50%) | 0/2 (0%) | 2/2 (100%) |
| Event | Treatment (Ribociclib, Aromatase Inhibitor) |
|---|---|
| NauseaGastrointestinal disorders | 2/2 |
| FatigueGeneral disorders | 2/2 |
| Alanine aminotransferase increasedInvestigations | 2/2 |
| Alkaline phosphatase increasedInvestigations | 2/2 |
| Aspartate aminotransferase increasedInvestigations | 2/2 |
| Neutrophil count decreasedInvestigations | 2/2 |
| White blood cell decreasedInvestigations | 2/2 |
| HyponatremiaMetabolism and nutrition disorders | 2/2 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/2 |
| AnemiaBlood and lymphatic system disorders | 1/2 |
| Age, Categorical(Participants) | Treatment (Ribociclib, Aromatase Inhibitor) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 0 |
| >=65 years | 2 |
| Sex: Female, Male(Participants) | Treatment (Ribociclib, Aromatase Inhibitor) |
|---|---|
| Female | 2 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Treatment (Ribociclib, Aromatase Inhibitor) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 2 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Treatment (Ribociclib, Aromatase Inhibitor) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Treatment (Ribociclib, Aromatase Inhibitor) |
|---|---|
| United States | 2 |
| Karnofsky Status(Participants) | Treatment (Ribociclib, Aromatase Inhibitor) |
|---|---|
| 100 - Normal no complaints; no evidence of disease | 1 |
| 90 - Able to carry on normal activity; minor signs or symptoms of disease | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jun 2018 to primary completion in Sep 2021, 39 months.
Results were first posted in May 2022, 7 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 39 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 Feb 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Aromatase inhibitors · Ribociclib