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Chemotherapy

Radiation, Immunotherapy, and Chemotherapy for Metastatic Triple Negative 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

HER2 negativity defined as ISH non-amplified or IHC 0 or IHC 1+

ER and PR negativity defined as ≤ 10% of cells expressing hormonal receptors via IHC analysis

Must not have

Acute bacterial or fungal infection requiring IV antibiotics

Known additional malignancy requiring active treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of radiation therapy to death, assessed up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing whether radiation therapy combined with pembrolizumab (immunotherapy) and different chemotherapy drugs can effectively treat patients with triple negative breast cancer that has spread to other parts of the

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

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My cancer is HER2 negative.

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My cancer is not driven by estrogen or progesterone.

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My breast cancer is PD-L1 positive, triple-negative, and has spread to at least 2 places.

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My cancer is PD-L1 positive with a score of 10 or higher.

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I have a cancer spot that can be treated with strong radiation.

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I am 18 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on IV antibiotics for a serious bacterial or fungal infection.

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I am currently being treated for another type of cancer.

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I have had treatment for triple negative breast cancer before starting pembrolizumab.

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I regularly use steroids or medications that suppress my immune system.

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The cancer spread I'm treating with radiation hasn't been radiated before.

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My brain disease has not been treated.

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I do not have uncontrolled fluid buildup in my chest or abdomen.

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I have had a stem cell or organ transplant in the past.

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I have high calcium levels in my blood that aren't managed.

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I have an autoimmune disease that needs treatment with medication.

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I have a history of lung conditions.

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I am HIV positive with a CD4 count below 200.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of radiation therapy to death, assessed up to 2 years

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Biospecimen Collection

2004

Completed Phase 3

~2020

Bone Scan

2015

Completed Phase 2

~50