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Alkylating agents

Pembrolizumab + Chemotherapy for Breast Cancer

Phase 2
Recruiting
Led By Oluchi Oke, MD
Research Sponsored by M.D. Anderson Cancer Center
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 through study completion; an average of 1 year.
Awards & highlights

Summary

"This trial is studying how well the combination of pembrolizumab, carboplatin, and paclitaxel works in people with a specific type of early-stage breast cancer called Triple Negative

Who is the study for?
This trial is for individuals with early-stage Triple Negative Breast Cancer (stage 1, tumors between 1-3 cm, no spread to lymph nodes or other body parts). Participants should not have had previous breast cancer treatment.
What is being tested?
The study tests the effectiveness of combining pembrolizumab (an immunotherapy drug) with carboplatin and paclitaxel (chemotherapy drugs) before surgery in patients with specific early-stage breast cancer.
What are the potential side effects?
Possible side effects include immune system reactions affecting organs, infusion-related symptoms, hair loss, nausea, fatigue, blood cell count changes increasing infection risk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and adverse events (AEs)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Pathologic Complete ResponseExperimental Treatment3 Interventions
If a participant's tissue shows a pathological complete response to treatment, participants will receive up to 13 cycles of pembrolizumab alone. Pathological complete response means that the study team cannot find any evidence of cancer in the breast or lymph node tissue sample that was removed during the participants surgery, after the participant completes the 4 cycles of carboplatin, pembrolizumab and paclitaxel.
Group II: Non-Pathologic Complete ResponseExperimental Treatment5 Interventions
If a participant's tissue does not show a pathological complete response, the participant will receive 4 cycles of pembrolizumab plus 2 other drugs (doxorubicin and cyclophosphamide), followed by 9 cycles of pembrolizumab alone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
2012
Completed Phase 3
~8030
Cyclophosphamide
2010
Completed Phase 4
~2320
Pembrolizumab
2017
Completed Phase 2
~2070
Paclitaxel
2011
Completed Phase 4
~5810
Carboplatin
2014
Completed Phase 3
~6120

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,747 Total Patients Enrolled
148 Trials studying Breast Cancer
63,277 Patients Enrolled for Breast Cancer
Oluchi Oke, MDPrincipal InvestigatorM.D. Anderson Cancer Center
~19 spots leftby Sep 2025
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