← Back to Search

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

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

My advanced breast cancer cannot be surgically removed with the aim of curing it.

Select...

My breast cancer is triple negative.

Select...

My breast cancer is confirmed HER2 positive by specific tests.

Select...

I am 18 years old or older.

Select...

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:

Select...

I have been diagnosed with HIV.

Select...

I haven't had cancer treatment in the last 2 weeks or still have side effects.

Select...

I have another cancer that is getting worse or needs treatment.

Select...

I have cancer that has spread to my brain or spinal cord.

Select...

I have received immunotherapy for cancer that has spread.

Select...

I have an immune system disorder or am on steroids/immunosuppressants.

Select...

I have an autoimmune disease treated with medication in the last 2 years.

Select...

I am currently being treated for an infection with medication.

Select...

I have or had lung inflammation that needed steroids.

Select...

I do not have active tuberculosis.

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

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

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

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

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

~3130

Carboplatin

2014

Completed Phase 3

~6120

Trastuzumab

2014

Completed Phase 4

~5190

0 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicOTHER

3,362 Previous Clinical Trials

3,066,054 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

2,339 Previous Clinical Trials

14,881,561 Total Patients Enrolled

28 Trials studying Breast Cancer

23,481 Patients Enrolled for Breast Cancer

Merck Sharp & Dohme LLCIndustry Sponsor

4,032 Previous Clinical Trials

5,189,646 Total Patients Enrolled

61 Trials studying Breast Cancer

7,639 Patients Enrolled for Breast Cancer

Massachusetts General HospitalOTHER

3,026 Previous Clinical Trials

13,413,719 Total Patients Enrolled

79 Trials studying Breast Cancer

131,101 Patients Enrolled for Breast Cancer

Hope Rugo, MDLead Sponsor

4 Previous Clinical Trials

251 Total Patients Enrolled

1 Trials studying Breast Cancer

30 Patients Enrolled for Breast Cancer

Neelima Vidula, MDPrincipal InvestigatorMassachusetts General Hospital

1 Previous Clinical Trials

30 Total Patients Enrolled

1 Trials studying Breast Cancer

30 Patients Enrolled for Breast Cancer

Hope Rugo3.713 ReviewsPrincipal Investigator - University of California, San Francisco

University of California, San Francisco

1 Previous Clinical Trials

2,104 Total Patients Enrolled

1 Trials studying Breast Cancer

2,104 Patients Enrolled for Breast Cancer

5Patient Review

Dr. Hope Rugo is simply the best in her field. I've seen her provide expert care to women who were told by other doctors that they only had a short time left. I've seen her work tirelessly to make sure that she sees every patient that was scheduled for that day. I've seen her educate other doctors who were using harmful chemo treatments on the women I brought to her. She is a God-sent and so many lives are depending on her that every second of her time is demanded. If you are annoyed by the long waits or the chaos of the clinic then you are missing the point. The care she provides

Neelima VidulaPrincipal InvestigatorMassachusetts General Hospital