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NCT02778685 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab, Endocrine Therapy, and Palbociclib in Treating Postmenopausal Patients With Newly Diagnosed Metastatic Stage IV Estrogen Receptor Positive Breast Cancer
A Phase 2 study of Metastatic Breast Carcinoma and Stage IV Breast Cancer AJCC v6 and v7, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
- 7
- Study locations
NCT02778685: Active Phase 2 study of Metastatic Breast Carcinoma and Stage IV Breast Cancer AJCC v6 and v7, sponsored by City of Hope Medical Center.
NCT02778685 is a Phase 2 study of Metastatic Breast Carcinoma and Stage IV Breast Cancer AJCC v6 and v7 that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 47 participants, below the 163-participant average among 32 other Metastatic Breast Carcinoma trials with a reported enrollment target (71% lower). The trial reports 7 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02778685, a Phase 2 study of Metastatic Breast Carcinoma and Stage IV Breast Cancer AJCC v6 and v7, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
- 7
- Study locations
Study Summary
This phase II trial studies how well pembrolizumab works when given together with endocrine therapy and palbociclib in treating postmenopausal patients with newly diagnosed stage IV estrogen receptor positive breast cancer that has spread to other parts of the body (metastatic). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Estrogen can cause the growth of breast cancer cells. Fulvestrant blocks the use of estrogen by the tumor cells. Letrozole lowers the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab, palbociclib, and letrozole or fulvestrant may be an effective treatment for patients with stage IV estrogen receptor positive breast cancer.
Primary Outcome
Assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Response rate was defined as the proportion of patients who had a partial or complete response to therapy.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- OTHER Laboratory Biomarker Analysis
- DRUG Letrozole
- DRUG Fulvestrant
- DRUG Palbociclib
Study Locations (7)
California
- City of Hope Corona - Corona
- City of Hope Medical Center - Duarte
- City of Hope Antelope Valley - Lancaster
- City of Hope Mission Hills - Mission Hills
- City of Hope South Pasadena - South Pasadena
- City of Hope Upland - Upland
- City of Hope West Covina - West Covina
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2016-09-30 |
| Est. Completion | 2026-03-30 |
| Phase | Phase 2 |
What the registry record for NCT02778685 still lists
NCT02778685 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 163-participant average among 32 other Metastatic Breast Carcinoma trials with a reported enrollment target (71% lower).
The record links to 2 conditions, with Metastatic Breast Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT02778685 lists 7 locations in 1 state (California).
Frequently Asked Questions
What is clinical trial NCT02778685 about?
NCT02778685 is a clinical study titled "Pembrolizumab, Endocrine Therapy, and Palbociclib in Treating Postmenopausal Patients With Newly Diagnosed Metastatic Stage IV Estrogen Receptor Positive Breast Cancer". This phase II trial studies how well pembrolizumab works when given together with endocrine therapy and palbociclib in treating postmenopausal patients with newly diagnosed stage IV estrogen receptor positive breast cancer that has spread to other parts of the body (metastatic). Immunotherapy with m...
What is the current status of trial NCT02778685?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2016-09-30. Estimated completion is 2026-03-30.
What conditions does trial NCT02778685 study?
This clinical trial studies the following conditions: Metastatic Breast Carcinoma, Stage IV Breast Cancer AJCC v6 and v7.
What interventions are being tested in trial NCT02778685?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Letrozole (DRUG), Fulvestrant (DRUG), Palbociclib (DRUG).
Who is sponsoring clinical trial NCT02778685?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02778685 being conducted?
This trial has 7 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02778685's enrollment target sits among peer trials
47 14th of 32 higher than 19 of 32 other Metastatic Breast Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Breast Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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