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Alkylating agents

Pembrolizumab + Carboplatin for Breast Cancer

Phase 2

Recruiting

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 weeks

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

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicOTHER

3,210 Previous Clinical Trials

3,766,889 Total Patients Enrolled

82 Trials studying Breast Cancer

13,726 Patients Enrolled for Breast Cancer

Translational Breast Cancer Research ConsortiumOTHER

22 Previous Clinical Trials

2,273 Total Patients Enrolled

12 Trials studying Breast Cancer

1,491 Patients Enrolled for Breast Cancer

Johns Hopkins UniversityOTHER

2,263 Previous Clinical Trials

14,823,081 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What illnesses has Pembrolizumab been demonstrated to alleviate?

"Pembrolizumab is often utilized to manage refractory and relapsed mediastinal large b-cell lymphoma. Additionally, it may be beneficial in the initial treatment of inflammatory breast cancer (IBC) and advanced testicular cancer."

Answered by AI

Does this research still have space for participants to join?

"Precisely. Clinicaltrials.gov attests that this clinical investigation, which was originally posted on September 2nd 2017, is actively enrolling individuals in need of medical care. 84 participants must be recruited from 7 distinct sites around the country."

Answered by AI

What is the total number of participants in this medical research project?

"Affirmative, the trial is actively recruiting based on information sourced from clinicaltrials.gov. It was initiated on September 2nd 2017 and last updated on August 8th 2022, with 84 patients needed to be enrolled across 7 sites."

Answered by AI

Are there any other studies which have utilized Pembrolizumab as a therapeutic agent?

"Currently, 1707 clinical trials featuring Pembrolizumab are being conducted. Out of those, 348 have entered Phase 3 testing. Seattle is one location where this treatment has been studied; however, there exist 83632 other sites hosting investigations into pembrozilium's efficacy."

Answered by AI

To what extent could Pembrolizumab potentially be hazardous to people?

"The safety of Pembrolizumab was rated a 2 on the Power scale due to Phase 2 status, meaning that while there is information suggesting it is safe for use, efficacy has not yet been determined."

Answered by AI

Could you enumerate the number of medical facilities administering this research study in the state?

"This research endeavour is running at 7 sites, which are located in cities like San Francisco, Indianapolis and Pittsburgh among a few other areas. To ensure minimal travel burden to the participant, it's important to choose the closest medical facility for enrollment."

Answered by AI

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