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Anti-metabolites

Pembrolizumab + Chemotherapy for Breast Cancer

Phase 1 & 2
Waitlist Available
Led By David Page, MD
Research Sponsored by Providence Health & Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be 18 years of age on day of signing informed consent
Have HER2-negative breast cancer (defined by immunohistochemistry (IHC) 0-1 or IHC 2 and in situ hybridization (ISH) HER2 / centromere on chromosome 17 (CEP17) < 2.0)
Must not have
Has a known history of active TB (Bacillus Tuberculosis)
Has received the assigned chemotherapy regimen previously in the metastatic setting, or has received the assigned chemotherapy regimen previously in the (neo)adjuvant setting within 12 months of consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the safety of giving pembrolizumab with either paclitaxel or capecitabine to people with triple negative breast cancer that has spread and cannot be removed by surgery.

Who is the study for?
This trial is for adults with metastatic/unresectable triple negative breast cancer who have not received certain treatments recently. Participants must be in good health, with proper organ function and performance status, and cannot be pregnant or breastfeeding. They should not have active infections or severe psychiatric issues that could affect participation.
What is being tested?
The study tests the safety of pembrolizumab combined with chemotherapy (paclitaxel or capecitabine) for patients with a specific type of advanced breast cancer. The goal is to see how well patients tolerate this combination therapy as their first or second-line treatment.
What are the potential side effects?
Pembrolizumab may cause immune-related side effects like inflammation in various organs, infusion reactions, fatigue, skin rash, and can increase infection risk. Chemotherapy drugs like paclitaxel and capecitabine can cause hair loss, nerve damage, nausea, diarrhea, low blood cell counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at least 18 years old.
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My breast cancer is HER2-negative.
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My breast cancer is not driven by estrogen or progesterone.
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My cancer can't be removed by surgery and its size can be measured.
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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of active tuberculosis.
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I have previously received the specified chemotherapy for my cancer.
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I have not received a live vaccine in the last 30 days.
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I have not taken steroids or immunosuppressants in the last 7 days.
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I have another cancer that has worsened or needed treatment in the past 5 years.
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I have been treated for an autoimmune disease in the last 2 years.
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I have or had lung inflammation or disease needing steroid treatment.
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I am currently being treated for an infection.
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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2, or was in a pembrolizumab study.
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I have been diagnosed with HIV.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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
Number of Patients Who Complete Chemotherapy Without a Dose Delay of More Than 21 Days.
Treatment-Associated Adverse Events Requiring Discontinuation
Secondary study objectives
Overall Response Rate

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 BExperimental Treatment2 Interventions
pembrolizumab + capecitabine
Group II: Arm AExperimental Treatment2 Interventions
pembrolizumab + weekly paclitaxel
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
2013
Completed Phase 3
~4280
Pembrolizumab
2017
Completed Phase 3
~3150
Paclitaxel
2011
Completed Phase 4
~5450

Find a Location

Who is running the clinical trial?

Providence Health & ServicesLead Sponsor
124 Previous Clinical Trials
823,758 Total Patients Enrolled
7 Trials studying Breast Cancer
4,608 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
4,027 Previous Clinical Trials
5,188,774 Total Patients Enrolled
62 Trials studying Breast Cancer
7,710 Patients Enrolled for Breast Cancer
David Page, MDPrincipal InvestigatorMedical Oncologist
5 Previous Clinical Trials
52 Total Patients Enrolled
3 Trials studying Breast Cancer
24 Patients Enrolled for Breast Cancer

Media Library

Capecitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02734290 — Phase 1 & 2
Breast Cancer Research Study Groups: Arm A, Arm B
Breast Cancer Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT02734290 — Phase 1 & 2
Capecitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02734290 — Phase 1 & 2
~3 spots leftby Dec 2025
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