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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
Must not have
Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered from adverse events due to a previously administered agent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with HIV.
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I haven't had cancer treatment in the last 2 weeks or still have side effects.
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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 received immunotherapy for cancer that has spread.
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I have an immune system disorder or am on steroids/immunosuppressants.
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I have an autoimmune disease treated with medication in the last 2 years.
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I am currently being treated for an infection with medication.
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I have or had lung inflammation that needed steroids.
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I do not have active tuberculosis.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease Control Rate (DCR)
Median Progression Free Survival (PFS)
Secondary study objectives
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 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%
Pneumonia aspiration
3%
Sepsis
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
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 3
~2810
Carboplatin
2014
Completed Phase 3
~6120
Trastuzumab
2014
Completed Phase 4
~5190

Find a Location

Who is running the clinical trial?

Mayo ClinicOTHER
3,319 Previous Clinical Trials
3,068,742 Total Patients Enrolled
83 Trials studying Breast Cancer
14,726 Patients Enrolled for Breast Cancer
Translational Breast Cancer Research ConsortiumOTHER
25 Previous Clinical Trials
2,905 Total Patients Enrolled
14 Trials studying Breast Cancer
1,923 Patients Enrolled for Breast Cancer
Johns Hopkins UniversityOTHER
2,317 Previous Clinical Trials
14,871,879 Total Patients Enrolled
28 Trials studying Breast Cancer
23,481 Patients Enrolled for Breast Cancer

Media Library

Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03095352 — Phase 2
~9 spots leftby Oct 2025
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