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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
Be indicated for treatment with either weekly paclitaxel or oral capecitabine, as first or second-line chemotherapy in the metastatic/unresectable setting as determined by the consenting investigator
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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I am eligible for treatment with paclitaxel or capecitabine as my first or second chemotherapy.
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I agree to provide a recent biopsy sample or use an old one if I haven't had cancer treatment since it was taken.
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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.
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My organ functions are within normal ranges as required.
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I must avoid pregnancy or fathering a child while on treatment.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Patients Who Complete Chemotherapy Without a Dose Delay of More Than 21 Days.
Treatment-Associated Adverse Events Requiring Discontinuation
Secondary outcome measures
Overall Response Rate

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
Pembrolizumab
2017
Completed Phase 2
~1950
Paclitaxel
2011
Completed Phase 4
~5380
Capecitabine
2013
Completed Phase 3
~3420

Find a Location

Who is running the clinical trial?

Providence Health & ServicesLead Sponsor
115 Previous Clinical Trials
122,494 Total Patients Enrolled
7 Trials studying Breast Cancer
4,608 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,671 Total Patients Enrolled
58 Trials studying Breast Cancer
7,456 Patients Enrolled for Breast Cancer
David Page, MDPrincipal InvestigatorMedical Oncologist
4 Previous Clinical Trials
40 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

Frequently Asked Questions

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

What therapeutic conditions are most often treated with Capecitabine?

"Capecitabine is a potent medication commonly prescribed to treat malignant neoplasms, neuroectodermal melanoma that can't be removed surgically, microsatellite instability high or when the risk of recurrence is particularly elevated."

Answered by AI

How many people are currently participating in the research endeavor?

"Unfortunately, this clinical trial is not actively enrolling patients. It was originally listed on February 23rd 2016 and the last update took place October 26th 2022. However, if you are still interested in participating there are currently 2,351 studies recruiting for triple negative breast neoplasms and 1,968 studies looking for volunteers to take part with Capecitabine trials."

Answered by AI

Are there any extant accounts related to Capecitabine efficacy?

"Presently, there are 1968 trials of Capecitabine taking place worldwide with 432 studies in Phase 3. Notably, Guangzhou, Guangdong alone has multiple active sites for the trial and 84040 locations globally have opened their doors to those seeking treatment with this medication."

Answered by AI

Is participation in this clinical investigation accessible to people at present?

"This clinical trial is no longer seeking participants for enrollment. The initial posting was made on February 23rd 2016, and the page has been recently edited as of October 26th 2022 should one wish to consult it. Alternatively, if you are searching for other studies involving triple negative breast neoplasms or Capecitabine there are presently 2351 and 1968 trials actively recruiting respectively."

Answered by AI
~3 spots leftby Mar 2025