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Hormone Therapy

Pembrolizumab + Fulvestrant for Breast Cancer

Phase 2
Waitlist Available
Led By Nancy Chan
Research Sponsored by Nancy Chan, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologic or cytologic diagnosis of metastatic breast cancer
Tumor is estrogen receptor positive (ER+) and/or (PR+), HER-2 negative (HER2-)
Must not have
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the combination of pembrolizumab and fulvestrant to treat hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer.

Who is the study for?
This trial is for adults with advanced breast cancer that's hormone receptor positive and HER-2 negative. Participants can have had no more than two prior treatments for metastatic disease, must not be pregnant or breastfeeding, agree to use contraception, and have good organ function and performance status. Exclusions include active infections, certain other cancers or treatments like anti-PD-1 drugs, live vaccines recently, or serious heart conditions.
What is being tested?
The study tests Pembrolizumab combined with Fulvestrant in patients with specific breast cancer types. It aims to see if this combination helps control the disease better than current standard options. The trial requires a new tissue biopsy from participants for analysis.
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation of organs (like lungs), skin reactions, liver issues; while Fulvestrant might lead to injection site pain, nausea, and bone marrow suppression which could increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer has spread and was confirmed by a lab test.
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My tumor is positive for estrogen or progesterone receptors and negative for HER2.
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I am willing to undergo a biopsy to provide a tissue sample.
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I have been mostly active and able to carry on all pre-disease activities without restriction recently.
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I've had at most two treatments for my advanced cancer that can't be surgically removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.
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I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.
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I have been diagnosed with HIV.
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I have or had lung inflammation that needed steroids.
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I am currently being treated for an infection.
Select...
I have cancer that has spread to my brain or spinal cord.
Select...
I have an active tuberculosis infection.
Select...
I have not had more than two types of chemotherapy or hormonal therapy.
Select...
I have another cancer that is getting worse or needs treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 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
Clinical Benefit Ratio (CBR)
Secondary study objectives
Durable response rate (DRR)
Overall Survival
Progression free survival (PFS)
+1 more

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
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Systemic infection
1%
Clostridium difficile colitis
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pembrolizumab + FulvestrantExperimental Treatment2 Interventions
Pembrolizumab 200m IV q3W + Fulvestrant. Loading dose 500mg IV IM q2W x3 followed by 500mg IM q4W
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~3150
Fulvestrant
2011
Completed Phase 3
~3790

Find a Location

Who is running the clinical trial?

Nancy Chan, MDLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
4,027 Previous Clinical Trials
5,188,756 Total Patients Enrolled
61 Trials studying Breast Cancer
7,663 Patients Enrolled for Breast Cancer
Nancy ChanPrincipal Investigator - Rutgers Cancer Institute of New Jersey
Big Ten Cancer Research Consortium

Media Library

Fulvestrant (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03393845 — Phase 2
Breast Cancer Research Study Groups: Pembrolizumab + Fulvestrant
Breast Cancer Clinical Trial 2023: Fulvestrant Highlights & Side Effects. Trial Name: NCT03393845 — Phase 2
Fulvestrant (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03393845 — Phase 2
~6 spots leftby Dec 2025
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