Study of Efficacy of Ribociclib After Progression on CDK4/6 Inhibition in Patients With HR+ HER2- Advanced Breast Cancer
Public ClinicalTrials.gov record NCT02632045. 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 randoMized phAse II trIal of fulvestraNt wiTh or Without Ribociclib After Progression on AntI-estrogeN Therapy Plus Cyclin-dependent Kinase 4/6 Inhibition in Patients With Unresectable or Metastatic Hormone Receptor +, HER2 - Breast Cancer (MAINTAIN Trial)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a randomized trial for patients with metastatic hormone receptor (HR)-positive human epidermal growth factor receptor 2 (HER2)-negative breast cancer who have progressed on an aromatase inhibitor plus a CDK4/6 inhibitor (either palbociclib or ribociclib) to either fulvestrant alone or fulvestrant with ribociclib (LEE-011). The purpose of the trial is to determine whether there is continued benefit for patients to remain on a CDK4/6 inhibitor at the time of switching anti-estrogen therapy. As ribociclib and palbociclib have a similar toxicity and drug profile and mechanism of action, the investigators feel that it is appropriate for patients to receive either drug with an aromatase inhibitor prior to randomization.
Study identification
- NCT ID
- NCT02632045
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 169 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- 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
- Mar 2016 (Actual)
- Primary completion
- Jan 4, 2022 (Actual)
- Completion
- Jan 4, 2022 (Actual)
- Last update posted
- Dec 6, 2024
2016 – 2022
United States locations
- U.S. sites
- 13
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham (UAB) | Birmingham | Alabama | 35294 | — |
| Northside Hospital, Inc. | Atlanta | Georgia | 30342 | — |
| Northwestern Medical Hospital | Chicago | Illinois | 60611 | — |
| The University of Kansas Cancer Center | Westwood | Kansas | 66205 | — |
| Northwell Health/Monter Cancer Center | Lake Success | New York | 11042 | — |
| NYU Langone Medical Center | New York | New York | 10016 | — |
| Mount Sinai Medical Center | New York | New York | 10029 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Weill Cornell Medical Center | New York | New York | 10065 | — |
| Stony Brook Cancer Center | Stony Brook | New York | 11794 | — |
| Albert Einstein University / Montefiore Medical Center | The Bronx | New York | 10461 | — |
| Vanderbilt-Ingham Cancer Center | Nashville | Tennessee | 37232 | — |
| University of Wisconsin School of Medicine | Madison | Wisconsin | 53792-001 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02632045, 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 Dec 6, 2024 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02632045 live on ClinicalTrials.gov.