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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

Must not have

Known history of HIV, active hepatitis B or hepatitis C

Received a live vaccine within 30 days of planned start of study therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of HIV or active hepatitis B/C.

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I have not received a live vaccine in the last 30 days.

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I have been treated with pembrolizumab or similar immunotherapy before.

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I have an immune system disorder or recently received treatment that weakens my immune system.

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I have an active tuberculosis infection.

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I have another cancer that is getting worse or needs treatment.

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I have cancer that has spread to my brain or spinal cord.

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I have a history of lung or significant heart disease.

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I am currently taking certain medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response rate (complete response or partial response)

Secondary study objectives

Complete response rate

Duration of response

Incidence of adverse events

+3 more

Other study objectives

Clinical benefit

Tumor response

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Diarrhea

Anemia

Shortness of Breath

Abdominal pain

Kidney Injury and/or Infection

Pneumonia

Weight Loss

Dyspnea

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Atrial fibrillation with rapid ventricular response

Pleural effusion

colitis

Thrombocytopenia

Respiratory failure

Skin rash

100%

80%

60%

40%

20%

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

Palbociclib

2017

Completed Phase 3

~3880

Pembrolizumab

2017

Completed Phase 2

~2070

Letrozole

2002

Completed Phase 4

~3590

Fulvestrant

FDA approved

0 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,842 Previous Clinical Trials

41,002,953 Total Patients Enrolled

945 Trials studying Breast Cancer

1,543,964 Patients Enrolled for Breast Cancer

City of Hope Medical CenterLead Sponsor

596 Previous Clinical Trials

1,923,490 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

~1 spots leftby Dec 2024

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