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

Part of paid clinical trials in Corona, California.

Sponsor
City of Hope Medical Center
Study ID
NCT02778685
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Breast Carcinoma
  • Stage IV Breast Cancer AJCC v6 and v7

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fulvestrant — DRUG
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Letrozole — DRUG
    Given PO
  • Palbociclib — DRUG
    Given PO
  • Pembrolizumab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Sep 30, 2016
Status verified
Feb 2026
Primary completion
Oct 31, 2025
Completion
Mar 30, 2026

Study Design

Enrollment
47 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 3 (Patients start Palbo+Letro on Day -28; pembro added on C1D1)
    Patients receive either letrozole PO QD on days -28 to -1 and days 1-28, or fulvestrant on days -28, -14, and day 1 of subsequent cycles. Patients also receive palbociclib PO QD for 3 weeks. Cycles with palbociclib, and letrozole or fulvestrant repeat every 28 days in the absence disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Cohorts 2 (Patients start letrozole + palbociclib + pembrolizumab as upfront therapy on C1D1)
    Patients receive letrozole PO QD on days 1-28 and palbociclib PO QD for 3 weeks. Cycles with letrozole and palbociclib repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Cohorts 1 (letrozole + palbociclib) on C1D1 and add pembrolizumab after 6 months
    Patients receive letrozole PO QD on days 1-28 and palbociclib PO QD for 3 weeks. Cycles with letrozole and palbociclib repeat every 28 days in the absence of disease progression or unacceptable toxicity. \^ months later, patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Response Rate (Complete Response or Partial Response) [ Time Frame: Up to 36 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
City of Hope CoronaCoronaCalifornia92879-
City of Hope Medical CenterDuarteCalifornia91010-
City of Hope Antelope ValleyLancasterCalifornia93534-
City of Hope Mission HillsMission HillsCalifornia91345-
City of Hope South PasadenaSouth PasadenaCalifornia91030-
City of Hope UplandUplandCalifornia91786-
City of Hope West CovinaWest CovinaCalifornia91790-

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