Pembrolizumab for Breast Cancer

Phase-Based Progress Estimates
Providence Portland Medical Center, Portland, ORBreast Cancer+1 MorePembrolizumab - Drug
All Sexes
What conditions do you have?

Study Summary

This trial is testing whether adding the immunotherapy drug pembrolizumab to standard chemotherapy can help treat triple negative breast cancer.

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Following definitive surgery, approximately 9 months.

Month 9
Safety and Tolerability Profile as assessed by CTCAE v5.0
Month 9
Pathological Complete Response (pCR) Rate (ypT0/Tis ypN0)
Safety and Tolerability Profile as assessed by tumor infiltrating lymphocytes

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Pembrolizumab Second Course
100%Inappropriate antidiuretic hormone secretion
100%Urinary tract infection
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Parkinsonism with 100%, Inappropriate antidiuretic hormone secretion with 100%, Urinary tract infection with 100%.

Trial Design

2 Treatment Groups

1 of 2
Arm A
1 of 2

Experimental Treatment

12 Total Participants · 2 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

Experimental Group · 1 Intervention: Pembrolizumab · Intervention Types: Drug
Arm AExperimental Group · 2 Interventions: Pembrolizumab, IRX 2 · Intervention Types: Drug, Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: following definitive surgery, approximately 9 months.

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,711 Previous Clinical Trials
4,967,386 Total Patients Enrolled
53 Trials studying Breast Cancer
7,171 Patients Enrolled for Breast Cancer
Providence Health & ServicesLead Sponsor
108 Previous Clinical Trials
53,377 Total Patients Enrolled
6 Trials studying Breast Cancer
4,716 Patients Enrolled for Breast Cancer
Brooklyn ImmunoTherapeutics, LLCIndustry Sponsor
7 Previous Clinical Trials
5,517 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

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Frequently Asked Questions

To which illnesses is Pembrolizumab typically prescribed?

"Pembrolizumab is frequently used to help patients with malignant neoplasms, particularly in cases of unresectable melanoma or where chemotherapy has failed. It can also assist those suffering from microsatellite instability high conditions." - Anonymous Online Contributor

Unverified Answer

Has Pembrolizumab been evaluated in earlier experiments?

"Currently, there are 964 ongoing studies for pembrolizumab with 122 of them in Phase 3. Primarily based in Houston, TX., this medication has been tested at over 35 thousand locations worldwide." - Anonymous Online Contributor

Unverified Answer

Is recruitment for this research endeavor still available?

"This clinical trial, which has been available since the 30th of December 2020 and was last amended on the 31st of January 2022 is actively seeking participants." - Anonymous Online Contributor

Unverified Answer

What has been the outcome of regulatory consideration for Pembrolizumab?

"Our team has assigned Pembrolizumab a safety rating of 2, as there is some evidence that it does not pose substantial risk to patients, but data supporting its efficacy in this particular Phase 2 trial remains inconclusive." - Anonymous Online Contributor

Unverified Answer

Can you provide an estimate of the total cohort size for this research study?

"Affirmative. verifies that this experiment is actively searching for participants; the original post was created on December 30th 2020 and edited most recently on January 31st 2022. The research requires a total of thirty patients from one specified medical site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.