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Chemotherapy

Treatment (radiation, pembrolizumab, chemotherapy) for Breast Cancer

Phase 2
Waitlist Available
Led By Manali Bhave, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Biopsy proven metastatic PD-L1 positive triple negative breast cancer with at least 2 sites of measurable metastatic disease on imaging
* Estrogen receptor (ER) and progesterone receptor (PR) negativity are defined as ≤ 10% of cells expressing hormonal receptors via immunohistochemistry (IHC) analysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of radiation therapy to death, assessed up to 2 years
Awards & highlights

Summary

This phase II trial tests how well radiation therapy with pembrolizumab and chemotherapy (paclitaxel or nab-paclitaxel or carboplatin and gemcitabine) works in treating patients with PD-L1 positive triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. Carboplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill cancer cells. High dose radiation therapy with pembrolizumab and chemotherapy may effective in treating patients with PD-L1 positive metastatic triple negative breast cancer.

Who is the study for?
This trial is for individuals with PD-L1 positive metastatic triple negative breast cancer. Participants should have cancer that has spread from the original site to other body parts. Specific eligibility criteria are not provided, but typically include factors like age, health status, and previous treatments.
What is being tested?
The study tests high dose radiation therapy combined with pembrolizumab (an immunotherapy drug) and chemotherapy drugs (paclitaxel or nab-paclitaxel or carboplatin and gemcitabine). The goal is to see if this combination can effectively kill tumor cells in patients with a specific type of advanced breast cancer.
What are the potential side effects?
Potential side effects may include typical reactions to radiation such as skin changes and fatigue; immune-related issues from pembrolizumab like inflammation; plus chemotherapy effects including nausea, hair loss, blood cell count changes, nerve damage, and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of radiation therapy to death, assessed up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of radiation therapy to death, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free survival (PFS)
Secondary study objectives
Incidence of adverse events (AEs)
Objective response rate (ORR)
Overall survival (OS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (radiation, pembrolizumab, chemotherapy)Experimental Treatment11 Interventions
Patients undergo radiation therapy once every other day for 3 doses. Beginning within 48 hours of their first dose of radiation therapy, patients receive standard of care pembrolizumab IV on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also receive 1 of 3 standard of care chemotherapy options: nab-paclitaxel IV on days 1, 8, and 15 of each cycle, or paclitaxel IV on days 1, 8, and 15 of each cycle, or carboplatin IV and gemcitabine IV on days 1 and 8 of each cycle. Cycles of nab-paclitaxel and paclitaxel repeat every 28 days and cycles of carboplatin and gemcitabine repeat every 21 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo a biopsy at baseline and 2 weeks after radiation therapy and also undergo CT scans, bone scans and blood sample collections throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Computed Tomography
2017
Completed Phase 2
~2720
Biospecimen Collection
2004
Completed Phase 2
~1720
Radiation Therapy
2017
Completed Phase 3
~7250
Nab-paclitaxel
2014
Completed Phase 3
~2030
Paclitaxel
2011
Completed Phase 4
~5380
Carboplatin
2014
Completed Phase 3
~6670
Biopsy
2014
Completed Phase 4
~1090
Gemcitabine
2017
Completed Phase 3
~2070
Bone Scan
2015
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,679 Previous Clinical Trials
2,580,012 Total Patients Enrolled
29 Trials studying Breast Cancer
7,528 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,831 Previous Clinical Trials
41,009,509 Total Patients Enrolled
945 Trials studying Breast Cancer
1,544,023 Patients Enrolled for Breast Cancer
Manali Bhave, MDPrincipal InvestigatorEmory University
1 Previous Clinical Trials
27 Total Patients Enrolled
~19 spots leftby Feb 2025