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Alkylating agents

Pembrolizumab for Breast Cancer

Phase 2

Recruiting

Led By Massimo Cristofanilli, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 9 weeks from the first study treatment, assessed up to 3 years

Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat metastatic breast cancer. The drugs are carboplatin and pembrolizumab. Pembrolizumab is an immune therapy drug that has the ability to restore the capacity of controlling and killing cancer cells of an important component of your immune system called T-cells.

Eligible Conditions

Breast Cancer
No change needed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 9 weeks from the first study treatment, assessed up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 9 weeks from the first study treatment, assessed up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 9 weeks from the first study treatment, assessed up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival (PFS)

Secondary outcome measures

CBR in relation to PDL-1 expression

Clinical Benefit Rate (CBR)

Immune-related clinical benefit rate

+5 more

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

1Treatment groups

Experimental Treatment

Group I: Treatment (pembrolizumab, carboplatin)Experimental Treatment3 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1 and carboplatin IV over 30-60 minutes on day 1 beginning with course 3. Courses repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

FDA approved

Pembrolizumab

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,585 Previous Clinical Trials

917,131 Total Patients Enrolled

39 Trials studying Breast Cancer

12,475 Patients Enrolled for Breast Cancer

Merck Sharp & Dohme LLCIndustry Sponsor

3,887 Previous Clinical Trials

5,054,874 Total Patients Enrolled

59 Trials studying Breast Cancer

7,534 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,389 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Frequently Asked Questions

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

How is Pembrolizumab typically employed to benefit patients?

"Pembrolizumab is a frequently utilized medication for malignant neoplasms. Other conditions it may be appropriate to treat include high risk of recurrence, unresectable melanoma, and microsatellite instability-high tumors."

Answered by AI

Have any prior experiments been conducted using Pembrolizumab?

"Currently, Pembrolizumab is the focus of 1546 ongoing investigations with 310 studies in their 3rd phase. While most trials are situated in Shanghai, there exist 71991 clinical trial sites running tests regarding this drug."

Answered by AI

How many participants are contributing to this medical experiment?

"Affirmative. Data hosted on clinicaltrials.gov establishes that this trial, which was initiated on September 14th 2017, is actively engaging in recruitment efforts. Approximately 100 patients are being sought out at one medical facility."

Answered by AI

Is this research initiative still recruiting participants?

"According to clinicaltrials.gov, this experiment is currently enrolling patients. It was first made public on September 14th 2017 and recently updated on April 30th 2021."

Answered by AI

Is Pembrolizumab associated with any significant risks for patients?

"Taking into account the data from its Phase 2 trial, our team at Power has assigned Pembrolizumab a safety rating of two due to some evidence for safety but not efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pembrolizumab and Carboplatin in Treating Patients With Circulating Tumor Cells Positive Metastatic Breast Cancer

2017. "Pembrolizumab and Carboplatin in Treating Patients With Circulating Tumor Cells Positive Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03213041.

All > Metastatic Breast Cancer