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Hormone Therapy

Immunotherapy + Hormone Therapy for Advanced Breast Cancer

Phase 2

Waitlist Available

Led By Joanne Mortimer

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

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

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 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + CRT Followed by Placebo

Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Pembrolizumab

2017

Completed Phase 3

~3130

Letrozole

2002

Completed Phase 4

~3150