Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer
Public ClinicalTrials.gov record NCT03822468. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
A Phase II, Multicenter, Randomized, Open-label Study to Evaluate the Safety and Efficacy of 400 mg of Ribociclib in Combination With Non-steroidal Aromatase Inhibitors for the Treatment of Pre- and Postmenopausal Women With Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the study was to evaluate the safety and efficacy of a reduced ribociclib starting dose of 400 mg in combination with a non-steroidal aromatase inhibitor (NSAI) (letrozole or anastrozole) for the treatment of pre- and postmenopausal women with hormone receptor-positive (HR-positive), HER2-negative advanced breast cancer (aBC) who have received no prior therapy for advanced disease. Premenopausal women were required to receive goserelin in both treatment arms.
Study identification
- NCT ID
- NCT03822468
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 376 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 100 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 11, 2019 (Actual)
- Primary completion
- Jun 11, 2021 (Actual)
- Completion
- Aug 30, 2024 (Actual)
- Last update posted
- Oct 16, 2025
2019 – 2024
United States locations
- U.S. sites
- 14
- U.S. states
- 10
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southern Cancer Center PC | Mobile | Alabama | 36608 | — |
| Marin Cancer Care | Greenbrae | California | 94904 | — |
| Rocky Mountain Cancer Centers | Longmont | Colorado | 80501 | — |
| Florida Retina Institute | Orlando | Florida | 32804 | — |
| Weinberg Cancer Institute at FSH | Baltimore | Maryland | 21237-3998 | — |
| Nebraska Hematology Oncology P C | Lincoln | Nebraska | 68506 | — |
| Nebraska Cancer Specialists | Omaha | Nebraska | 68154 | — |
| Comprehensive Cancer Cntr Of Nevada | Henderson | Nevada | 89052 | — |
| New York Oncology Hematology | Albany | New York | 12208 | — |
| Mount Sinai School Of Medicine | New York | New York | 10029 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Millennium Research Clin Develop | Houston | Texas | 77090 | — |
| Texas Oncology | McAllen | Texas | 78503 | — |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 75 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03822468, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 16, 2025 · Synced Nov 5, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03822468 live on ClinicalTrials.gov.