An observational study in Breast Cancer, sponsored by Novartis Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Observational
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Among 199 studies in Breast Neoplasms by Novartis — 16 open to participants now, 30 under way, 4 of them phase 3. Breast Neoplasms · Novartis.
Among the 199 studies in Breast Neoplasms by Novartis, this one is the 16th largest by enrollment of the 38 observational ones that give a count, is one of 8 that started in 2025, is one of 38 observational ones, and was the 198th registered.
14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.
Browse Breast Neoplasms studies →16 of the 199 studies in Breast Neoplasms by Novartis are open now, in 12 countries. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in Australia, Japan
Ages 18+
Novartis Pharmaceuticals · Sites in Netherlands
Ages 18–100
Novartis Pharmaceuticals · Sites in United States, Australia, Canada and 1 more country
Ages 18+
Novartis Pharmaceuticals · Sites in United States, Canada, France and 6 more countries
Ages 18+
Novartis Pharmaceuticals · Sites in China
Ages 18–99
By country, each count listing its studies:
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 to 120 Years · 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.
199 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 52 · Phase 2 54 · Phase 3 48 · Phase 4 17
First in 1998; this study’s year is marked. 8 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 945 is above the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Median enrollment 104 across the 155 interventional studies, 538 across the 38 observational. Of the 160 that completed or were terminated, 74 (46%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under Novartis Pharmaceuticals, one of the names counted as Novartis. Under that name alone:
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
10 of the studies in Breast Neoplasms by Novartis that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05038735Phase 3Novartis PharmaceuticalsStudy to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor. | 2027-01-28 |
| NCT04208178Phase 3Novartis PharmaceuticalsStudy of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation | 2027-02-26 |
| NCT05870579Novartis Pharmaceuticals[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer | 2026-12-30 |
| NCT04544189Novartis PharmaceuticalsStudy Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer | 2027-01-29 |
| NCT01872260Novartis PharmaceuticalsStudy of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer | 2027-02-26 |
Add all 10 to your calendar (.ics) → With an account.
Among the 199 studies in Breast Neoplasms by Novartis, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The aim of this study was to assess real-world treatment patterns and tolerability of ribociclib among patient populations historically underrepresented in clinical trials - specifically older adults and Black/African American patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC).
The study was conducted using data from a nationwide database derived from electronic health record (EHR) data collected from oncology practices across the United States. The study population was drawn from community and academic oncology practices within the health research network.
HR+/HER2- recurrent or mBC cancer patients aged 65 years or older, and who self-identify as African American, and initiated 1L ribociclib plus ET on or after January 01, 2018.
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.
Included in Flatiron's mBC Enhanced Data Model (EDM):
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.
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.
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.
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.
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.
HR+/HER2- mBC cancer patients aged 65 years or older who initiated 1L ribociclib plus ET on or after January 01, 2018.
HR+/HER2- mBC cancer patients aged 75 years or older who initiated 1L ribociclib plus ET on or after January 01, 2018.
HR+/HER2- mBC cancer patients aged 65 years or older who self-identify as Black/African American and initiated 1L ribociclib plus ET on or after January 01, 2018.
This study also gives Ribociclib. No intervention listed here names it: that was found by reading the record.
Number of Patients Who Initiated 1L Ribociclib Treatment for HR+/HER2- mBC, by Demographic and Clinical Characteristics Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Demographics and clinical characteristics included race/ethnicity, practice type, geographic region, insurance type, socioeconomic status (SES) quintile, stage at initial diagnosis, menopausal status at 1L start, sites of metastasis, endocrine sensitivity status, year of 1L initiation, and prior chemotherapy exposure.
Time frame: Baseline
Age at 1L Ribociclib Initiation Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Time frame: Baseline
Body Mass Index (BMI) at 1L Ribociclib Initiation Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Time frame: Baseline
Number of Patients by Eastern Cooperative Oncology Group (ECOG) Performance Status Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older,
ECOG performance status is a scale used to measure a patient's level of functioning in terms of self-care, daily activity, and physical ability. Scores range from 0 (fully active, able to carry out all pre-disease performance without restriction) to 5 (deceased).
Time frame: Baseline
Duration Between Metastatic Diagnosis and 1L Ribociclib Initiation Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Time frame: Baseline
Number of Patients by Initial and Subsequent Dosing Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Time frame: Up to approximately 6 years, 10 months
Number of Patients With Dose Modifications Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Dose modifications defined as a dose being held, increased, or decreased.
Time frame: Up to approximately 6 years, 10 months
Number of Patients by Reasons for Dose Modifications Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Dose modifications defined as a dose being held, increased, or decreased.
Time frame: Up to approximately 6 years, 10 months
Number of Patients Who Discontinued Treatment Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Time frame: Up to approximately 6 years, 10 months
Number of Patients by Reason for Treatment Discontinuation Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Time frame: Up to approximately 6 years, 10 months
Number of Patients Who Initiated 1L Ribociclib Treatment for HR+/HER2- mBC, by Demographic and Clinical Characteristics Among Black/African American Patients
Demographics and clinical characteristics included race/ethnicity, practice type, geographic region, insurance type, socioeconomic status (SES) quintile, stage at initial diagnosis, menopausal status at 1L start, sites of metastasis, endocrine sensitivity status, year of 1L initiation, and prior chemotherapy exposure.
Time frame: Baseline
Age at 1L Ribociclib Initiation Among Black/African American Patients
Time frame: Baseline
BMI at 1L Ribociclib Initiation Among Black/African American Patients
Time frame: Baseline
Number of Patients by ECOG Performance Status Among Black/African American Patients
ECOG performance status is a scale used to measure a patient's level of functioning in terms of self-care, daily activity, and physical ability. Scores range from 0 (fully active, able to carry out all pre-disease performance without restriction) to 5 (deceased).
Time frame: Baseline
Duration Between Metastatic Diagnosis and 1L Ribociclib Initiation Among Black/African American Patients
Time frame: Baseline
Number of Patients by Initial and Subsequent Dosing Among Black/African American Patients
Time frame: Up to approximately 6 years, 10 months
Number of Patients With Dose Modifications Among Black/African American Patients
Dose modifications defined as a dose being held, increased, or decreased.
Time frame: Up to approximately 6 years, 10 months
Number of Patients by Reasons for Dose Modifications Among Black/African American Patients
Dose modifications defined as a dose being held, increased, or decreased.
Time frame: Up to approximately 6 years, 10 months
Number of Patients Who Discontinued Treatment Among Black/African American Patients
Time frame: Up to approximately 6 years, 10 months
Number of Patients by Reason for Treatment Discontinuation Among Black/African American Patients
Time frame: Up to approximately 6 years, 10 months
Plan to share: No
Ran from Feb 2025 to primary completion in Aug 2025, 6 months.
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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