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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Study identification
- NCT ID
- NCT03822468
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Novartis Pharmaceuticals
- Industry
- Enrollment
- 376 participants
Conditions and interventions
Conditions
Interventions
- Anastrozole Drug
- Goserelin Drug
- Letrozole Drug
- Ribociclib Drug
Drug
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 10, 2019
- Primary completion
- Jun 10, 2021
- Completion
- Aug 29, 2024
- Last update posted
- Oct 15, 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 15, 2025 · Synced May 12, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03822468 live on ClinicalTrials.gov.