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Anti-estrogen
Pembrolizumab + Chemotherapy/Anti-Estrogen for Breast Cancer
Phase 2
Waitlist Available
Led By James Waisman, MD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing pembrolizumab with doxorubicin or anti-estrogen therapy compared to pembrolizumab alone to see if it is an effective treatment for patients with hormone-receptor positive or triple-negative breast cancer.
Who is the study for?
This trial is for adults with stage IV metastatic triple-negative or hormone-receptor positive breast cancer. Participants must be in good physical condition (ECOG 0-1), able to provide a new tumor tissue sample, and have measurable disease. Post-menopausal women are eligible if they have hormone receptor-positive cancer. Exclusions include recent participation in other studies, certain health conditions like pneumonitis or TB, known psychiatric disorders that affect compliance, recent live vaccines, immunodeficiency states, pregnancy, prior specific treatments including pembrolizumab and anthracyclines.Check my eligibility
What is being tested?
The study compares the effectiveness of pembrolizumab combined with doxorubicin hydrochloride versus pembrolizumab with anti-estrogen therapy (anastrozole, letrozole or exemestane) for treating advanced breast cancer. Pembrolizumab boosts the immune system's response against cancer cells while doxorubicin hydrochloride stops their growth; anti-estrogen therapy lowers estrogen levels to combat hormone receptor-positive cancers.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in organs and infusion reactions. Doxorubicin can lead to heart damage and blood cell count issues. Anti-estrogen drugs might cause hot flashes, joint pain and osteoporosis. Side effects vary based on individual patient factors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Overall Response
Secondary outcome measures
Clinical Benefit Rate
Overall Survival (OS)
Progression-free Survival (PFS)
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2 (pembrolizumab, anti-estrogen therapy)Experimental Treatment5 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1 and an aromatase inhibitor (exemestane, anastrozole, or letrozole) PO QD on days 1-21. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity.
In both arms, patients who stop pembrolizumab with stable disease or better may receive additional pembrolizumab therapy for up to 1 year if they progress after stopping study treatment.
Group II: Cohort 1 (pembrolizumab, doxorubicin hydrochloride)Experimental Treatment3 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1 and doxorubicin hydrochloride IV on day 1. Treatment repeats every 3 weeks for 6 courses, and then continues for up to 24 months with pembrolizumab alone in the absence of disease progression or unacceptable toxicity.
Patients who stop pembrolizumab with stable disease or better may receive additional pembrolizumab therapy for up to 1 year if they progress after stopping study treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anastrozole
2019
Completed Phase 4
~10300
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Exemestane
2003
Completed Phase 4
~7630
Pembrolizumab
2017
Completed Phase 2
~2010
Letrozole
2002
Completed Phase 4
~2770
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
570 Previous Clinical Trials
1,922,586 Total Patients Enrolled
43 Trials studying Breast Cancer
6,649 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,334 Total Patients Enrolled
942 Trials studying Breast Cancer
1,543,966 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,906 Previous Clinical Trials
5,064,788 Total Patients Enrolled
59 Trials studying Breast Cancer
7,406 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a lung problem that was not caused by an infection and needed steroids to treat, or you currently have a lung problem.You have stage IV triple negative breast cancer or stage IV HR+ HER2- breast cancer.You have active tuberculosis, allergic reactions to pembrolizumab, or heart problems.You have a weakened immune system or have been taking strong medications that weaken your immune system within the last 7 days before starting the trial treatment.You have previously been treated with anthracycline for triple negative breast cancer.You have had or currently have a lung disease called pneumonitis or interstitial lung disease that needed treatment with steroids.You have a history of HIV or active hepatitis B or C.You are willing to give a small piece of tissue from a recent tumor biopsy.You have a disease that can be measured using a specific method called RECIST 1.1.Your blood and body chemistry levels need to be within certain ranges.Women in cohort 2 have reached menopause and have hormone receptor-positive stage IV breast cancer.You have tried all three approved aromatase inhibitors for HR+ breast cancer, but they did not work for you.You have cancer that has spread to your brain or spinal cord, unless it is not getting worse.You have had another type of cancer that got worse or needed treatment in the last 5 years, unless in certain situations.You have a serious infection that needs treatment with medication throughout your body.You have had an autoimmune disease that needed medication in the past 2 years.You have already been treated with a specific type of medication that targets the immune system.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1 (pembrolizumab, doxorubicin hydrochloride)
- Group 2: Cohort 2 (pembrolizumab, anti-estrogen therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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