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Alkylating agents

Pembrolizumab + Carboplatin for Breast Cancer

Phase 2
Waitlist Available
Led By Neelima Vidula, MD
Research Sponsored by Hope Rugo, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
Advanced breast cancer with locally recurrent chest wall disease not amenable to surgical excision with curative intent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 weeks
Awards & highlights

Study Summary

This trial is testing a new cancer treatment combining pembrolizumab with carboplatin, to see if it is more effective than carboplatin alone, in treating breast cancer that has spread to the chest wall and is resistant to hormone therapy.

Who is the study for?
This trial is for adults with breast cancer and chest wall disease that's hormone resistant or triple negative, who've tried at least two hormonal therapies without success. They must be in good enough health to participate, have no serious psychiatric issues or substance abuse problems, not be pregnant or breastfeeding, and have no recent vaccines or other treatments that could interfere.Check my eligibility
What is being tested?
The study compares the effectiveness of Pembrolizumab combined with Carboplatin versus Carboplatin alone in treating breast cancer patients. Participants are randomly assigned to either receive both drugs (Arm A) or just Carboplatin (Arm B), with an option to switch to Pembrolizumab after progression. The main goal is to see which treatment better controls the disease after 18 weeks.See study design
What are the potential side effects?
Pembrolizumab may cause immune system-related side effects like inflammation in various organs, skin reactions, fatigue, and can affect liver enzymes. Carboplatin commonly causes nausea, low blood counts leading to increased infection risk and bleeding complications; it might also cause kidney damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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My advanced breast cancer cannot be surgically removed with the aim of curing it.
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My breast cancer is triple negative.
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My breast cancer is confirmed HER2 positive by specific tests.
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I am 18 years old or older.
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I can provide a new biopsy sample from my chest wall tumor.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease Control Rate (DCR)
Median Progression Free Survival (PFS)
Secondary outcome measures
DCR by immune-related (ir) RECIST
Number of participants with treatment-related adverse events (AEs)
Objective Response Rate (ORR)

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: Arm B: Carboplatin Monotherapy, then Pembrolizumab for participants who progress onlyExperimental Treatment3 Interventions
Patients receive carboplatin IV on day 1. Patients who are HER2+ also receive trastuzumab IV every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease progression then receive pembrolizumab IV over 30 minutes on day 1 in the cross over (Arm Bx). Carboplatin may be continued or added back into the treatment regimen at the investigator's discretion. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Arm A: Pembrolizumab + CarboplatinExperimental Treatment3 Interventions
Patients receive carboplatin intravenously (IV) and pembrolizumab IV over 30 minutes on day 1. Patients who are HER2+ also receive trastuzumab IV every 3 weeks. Treatment repeats every 3 weeks for a least 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 cycles of carboplatin and pembrolizumab, patients then receive pembrolizumab alone on day 1. Cycles repeat every 3 weeks 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 2
~2010
Carboplatin
2014
Completed Phase 3
~6670
Trastuzumab
2014
Completed Phase 4
~5190

Find a Location

Who is running the clinical trial?

Mayo ClinicOTHER
3,244 Previous Clinical Trials
3,773,274 Total Patients Enrolled
82 Trials studying Breast Cancer
13,726 Patients Enrolled for Breast Cancer
Translational Breast Cancer Research ConsortiumOTHER
22 Previous Clinical Trials
2,276 Total Patients Enrolled
12 Trials studying Breast Cancer
1,494 Patients Enrolled for Breast Cancer
Johns Hopkins UniversityOTHER
2,274 Previous Clinical Trials
14,840,448 Total Patients Enrolled
27 Trials studying Breast Cancer
23,424 Patients Enrolled for Breast Cancer

Media Library

Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03095352 — Phase 2
~2 spots leftby Aug 2024
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