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Alkylating agents

Pembrolizumab + Chemotherapy for Breast Cancer

Phase 2
Waitlist Available
Led By Elias Obeid, MD
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients are candidates for chemotherapy with carboplatin and gemcitabine
Have either Evaluable disease, or have measurable clinical disease: Measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT scan as defined by RECIST (version v1.1)
Must not have
History of any lymphoproliferative disorder
Patients who received prior therapy using carboplatin/gemcitabine within 12 months prior to enrollment or subjects whose tumor progressed while on treatment with carboplatin or cisplatin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start of treatment until death (assessed up to 60 months.)
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the safety and effectiveness of Pembrolizumab in combination with chemotherapy (carboplatin and gemcitabine) in patients with metastatic triple negative breast cancer.

Who is the study for?
This trial is for women over 18 with metastatic triple negative breast cancer who haven't had certain treatments in the last few weeks and have adequate organ function. They must not be pregnant, agree to use birth control, and provide tissue samples. Exclusions include other active cancers, severe health conditions, or recent participation in another investigational study.
What is being tested?
The trial tests Pembrolizumab combined with chemotherapy drugs Carboplatin and Gemcitabine for safety and effectiveness against metastatic triple negative breast cancer. Pembrolizumab has been used for melanoma and lung cancer but isn't yet approved for breast cancer treatment.
What are the potential side effects?
Potential side effects may include immune system reactions that can affect organs, infusion-related responses, fatigue, nausea or vomiting from chemotherapy drugs. Each patient's experience with side effects could vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am eligible for chemotherapy with carboplatin and gemcitabine.
Select...
My cancer can be measured by scans.
Select...
My cancer has spread and cannot be removed by surgery.
Select...
I can take care of myself and am up and about more than half of the day.
Select...
I have had up to 2 treatments for my cancer after it spread.
Select...
My breast cancer is triple negative for ER, PR, and HER2.
Select...
My cancer is hormone receptor negative and HER2 negative.
Select...
I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a condition where my lymphocytes grow abnormally.
Select...
My cancer progressed despite treatment with carboplatin or cisplatin, or I received carboplatin/gemcitabine within the last year.
Select...
I have moderate nerve pain or tingling.
Select...
My breast cancer is hormone-receptor positive and HER-2 positive.
Select...
I have an autoimmune disease but haven't needed systemic treatment in the last 2 years.
Select...
I have a lung condition not caused by an infection.
Select...
I haven't had cancer treatment in the last 2 weeks or still have side effects.
Select...
I have had another cancer that got worse or needed treatment in the past 5 years.
Select...
I have previously been treated with specific immune therapy drugs.
Select...
I have cancer that has spread to my brain or spinal cord.
Select...
I agree to give tissue samples before and after treatment for research.
Select...
I have a history of cancer.
Select...
I am currently being treated for an infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of treatment until death (assessed up to 60 months.)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of treatment until death (assessed up to 60 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
Incidence of Treatment-Related Adverse Events
Objective Response Rate
Secondary study objectives
Clinical Benefit Rate
Overall Survival
Progression Free Survival

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%
Clostridium difficile colitis
1%
Systemic infection
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
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab with Standard ChemotherapyExperimental Treatment3 Interventions
Pembrolizumab plus standard chemotherapy using carboplatin and gemcitabine.
Group II: Standard Chemotherapy AloneActive Control2 Interventions
Standard chemotherapy alone using carboplatin and gemcitabine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2810
Carboplatin
2014
Completed Phase 3
~6120
Gemcitabine
2017
Completed Phase 3
~1920

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonOTHER
1,229 Previous Clinical Trials
3,199,702 Total Patients Enrolled
Fox Chase Cancer CenterLead Sponsor
234 Previous Clinical Trials
39,286 Total Patients Enrolled
Elias Obeid, MDPrincipal InvestigatorFox Chase Cancer Center

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02755272 — Phase 2
Breast cancer Research Study Groups: Pembrolizumab with Standard Chemotherapy, Standard Chemotherapy Alone
Breast cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT02755272 — Phase 2
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02755272 — Phase 2
~4 spots leftby May 2025
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