Pembrolizumab, Endocrine Therapy, and Palbociclib in Treating Postmenopausal Patients With Newly Diagnosed Metastatic Stage IV Estrogen Receptor Positive Breast Cancer

ClinicalTrials.gov ID: NCT02778685

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Official title

Phase II Study of the Combination of Pembrolizumab, Letrozole, and Palbociclib in Postmenopausal Patients With Newly Diagnosed Metastatic Estrogen Receptor Positive Breast Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT02778685
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: City of Hope Medical Center; Other
Enrollment: 47 participants

Conditions and interventions

Conditions

Interventions

Drug · Other · Biological

Eligibility (public fields only)

Age range: 18 Years and older
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: Sep 30, 2016 (Actual)
Primary completion: Oct 31, 2025 (Actual)
Completion: Mar 30, 2026 (Estimated)
Last update posted: Feb 24, 2026

2016 – 2026

United States locations

U.S. sites: 7
U.S. states: 1
U.S. cities: 7

Facility	City	State	ZIP	Site status
City of Hope Corona	Corona	California	92879	—
City of Hope Medical Center	Duarte	California	91010	—
City of Hope Antelope Valley	Lancaster	California	93534	—
City of Hope Mission Hills	Mission Hills	California	91345	—
City of Hope South Pasadena	South Pasadena	California	91030	—
City of Hope Upland	Upland	California	91786	—
City of Hope West Covina	West Covina	California	91790	—

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 NCT02778685, 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 Feb 24, 2026 · Synced Nov 12, 2026