Study on Pembrolizumab, Endocrine Therapy, and Palbociclib for Treating Postmenopausal Patients with Advanced Estrogen Receptor Positive Breast Cancer

Sponsor: City of Hope Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT02778685

Provider View

This clinical trial is exploring a combination of pembrolizumab, endocrine therapy, and palbociclib to treat postmenopausal women with newly diagnosed stage IV estrogen receptor positive breast cancer that has spread to other parts of the body. The study aims to see if this combination can effectively control the cancer.

Patient Parameters

Program Overview

This study is testing a treatment combination for postmenopausal women with advanced estrogen receptor positive breast cancer that has spread. The treatment includes pembrolizumab, which helps the immune system attack cancer cells, and endocrine therapies like letrozole and fulvestrant, which block estrogen that fuels cancer growth. Palbociclib is also used to stop cancer cells from growing. Researchers want to see if this combination can effectively treat this type of breast cancer.

Description

The main goal of this study is to see how well the combination of pembrolizumab, letrozole, and palbociclib works in treating advanced estrogen receptor positive breast cancer. Researchers will measure the response rate, which includes complete and partial responses to the treatment. They will also look at changes in certain immune cells in the blood to predict treatment response.

Secondary goals include assessing the safety and side effects of the treatment, as well as measuring how long patients live without the cancer getting worse and overall survival rates. Researchers will also evaluate how long the response to treatment lasts and the overall benefit of the treatment.

The study will explore how the treatment affects immune responses and changes in tumor DNA. Patients will be divided into different groups to receive the treatment, which includes taking letrozole or fulvestrant and palbociclib by mouth, and pembrolizumab through an IV. The treatment cycles will repeat every few weeks as long as the cancer does not progress and side effects are manageable.

After completing the treatment, patients will have follow-up visits to monitor their health and the effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be willing to provide written consent to participate.
  • Must be 18 years or older.
  • Must be able to follow the study procedures.
  • Must be postmenopausal, defined by specific medical criteria.
  • Must have measurable cancer that meets certain size criteria.
  • Must have stage IV estrogen receptor positive, HER2 negative breast cancer.
  • Must have a life expectancy of at least 3 months.
  • Must have a performance status indicating they are fully active or able to carry out light work.
  • Must be willing to provide a tumor sample for analysis.
  • Must have adequate blood cell counts and organ function as determined by specific tests.
  • Female participants of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 120 days after the last dose of study medication.

Exclusion Criteria

  • Currently participating in another study or have recently participated in one.
  • Have previously received pembrolizumab or similar immunotherapy.
  • Do not have measurable disease.
  • Have received certain treatments for more than the allowed time before screening.
  • Have an immune deficiency or are taking immunosuppressive drugs.
  • Have a history of active tuberculosis.
  • Have allergies to pembrolizumab or its components.
  • Have had recent chemotherapy or radiation therapy and have not recovered from side effects.
  • Have another active cancer requiring treatment.
  • Have active brain metastases or certain neurological conditions.
  • Have an active autoimmune disease requiring treatment in the past 2 years.
  • Have a history of lung disease or current lung issues.
  • Have active infections requiring treatment.
  • Have significant heart disease or abnormal heart rhythms.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Have a history of psychiatric or substance abuse disorders that would interfere with the study.
  • Have active hepatitis B or C, or HIV.
  • Have received a live vaccine recently.

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