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Hormone Therapy

Immunotherapy + Hormone Therapy for Advanced Breast Cancer

Phase 2
Recruiting
Led By Yuan Yuan, MD, PhD
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
Stage IV metastatic ER+HER2- breast cancer histologically proven per current guidelines
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial is testing a possible new treatment regimen for stage IV breast cancer that has spread. The regimen includes the immunotherapy drug pembrolizumab, and two drugs that target estrogen (fulvestrant or letrozole), plus the drug palbociclib.

Who is the study for?
This trial is for postmenopausal women with newly diagnosed stage IV estrogen receptor positive breast cancer. Participants must be over 18, willing to provide consent and tissue samples, have a life expectancy of at least 3 months, and meet specific health criteria. They cannot join if they have brain metastases, received certain vaccines or treatments recently, are pregnant/breastfeeding, or have serious health issues like active autoimmune diseases.Check my eligibility
What is being tested?
The study tests pembrolizumab (an immunotherapy drug) combined with endocrine therapy (fulvestrant or letrozole) and palbociclib against metastatic breast cancer. It aims to see if this combination can help the immune system fight cancer and stop tumor growth by blocking hormones and enzymes that cancer cells need.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal organs (autoimmune reactions), infusion-related symptoms such as fever or chills, fatigue, hormonal imbalances due to endocrine therapy, liver function changes, blood clotting issues, anemia or low white blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is stage IV, ER positive, HER2 negative, and confirmed by tests.
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I can take care of myself and am up and about more than half of the day.
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My cancer can be measured by tests.
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I am willing to undergo a biopsy to provide a tissue sample.
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My kidney function meets the required levels.
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My liver is functioning within normal ranges.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Response rate (complete response or partial response)
Secondary outcome measures
Complete response rate
Duration of response
Incidence of adverse events
+3 more
Other outcome measures
Clinical benefit
Tumor response

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
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: Cohorts 1 and 2 (letrozole, palbociclib, pembrolizumab)Experimental Treatment4 Interventions
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.
Group II: Cohort 3 (letrozole, palbociclib, fulvestrant, pembrolizumab)Experimental Treatment5 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
FDA approved
Letrozole
2002
Completed Phase 4
~2770
Palbociclib
2017
Completed Phase 3
~3760
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,721 Previous Clinical Trials
40,965,007 Total Patients Enrolled
942 Trials studying Breast Cancer
1,543,966 Patients Enrolled for Breast Cancer
City of Hope Medical CenterLead Sponsor
570 Previous Clinical Trials
1,922,529 Total Patients Enrolled
43 Trials studying Breast Cancer
6,649 Patients Enrolled for Breast Cancer
Yuan Yuan, MD, PhDPrincipal InvestigatorCity of Hope Medical Center
4 Previous Clinical Trials
430 Total Patients Enrolled
~3 spots leftby Dec 2024
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