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Anti-metabolites

Shorter Chemo-Immunotherapy Without Anthracyclines for Breast Cancer

Phase 3

Recruiting

Led By Priyanka Sharma

Research Sponsored by SWOG Cancer Research Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must not have a history of (non-infectious) pneumonitis that required steroids, or has current (non-infectious) pneumonitis

Participants must be >= 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial compares shorter chemo-immunotherapy without anthracyclines to usual chemo-immunotherapy to treat early-stage triple negative breast cancer. Drugs used to stop cancer cells from growing/dividing & kill them, plus an immunotherapy drug.

Who is the study for?

This trial is for adults with early-stage triple negative breast cancer who haven't had systemic or radiation therapy, or breast surgery for their current cancer. They must have good heart function and no severe allergies to the study drugs. Participants can't be pregnant/nursing and must agree to use contraception. No live vaccines 30 days before joining, no uncontrolled diseases like diabetes or hypertension, and they shouldn't have a history of certain infections or other cancers that could affect the trial.

What is being tested?

The trial tests if shorter chemo-immunotherapy without anthracycline drugs (like Doxorubicin) is as effective as usual treatment in early-stage triple negative breast cancer. It involves medications such as Paclitaxel, Carboplatin, Cyclophosphamide, Docetaxel, and Pembrolizumab which target different aspects of cancer cell growth.

What are the potential side effects?

Possible side effects include fatigue; hair loss; nausea; low blood counts leading to increased infection risk; nerve damage causing numbness or tingling; allergic reactions; heart problems from some chemotherapy drugs; immune-related issues like inflammation from Pembrolizumab.

Eligibility Criteria

Inclusion Criteria

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

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I have never needed steroids for non-infectious lung inflammation.

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I am 18 years old or older.

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I haven't had severe infections or been hospitalized for one in the last 14 days.

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Both of my breast cancers are negative for ER, PR, and HER2.

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My cancer has not spread to distant parts of my body.

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My heart is strong enough for the trial, with an ejection fraction of 50% or more.

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I am not on high-dose steroids or other drugs that weaken my immune system.

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I can provide a specific slide from my initial cancer diagnosis.

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I haven't had a live vaccine in the last 30 days.

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I have not had surgery on the breast currently affected by cancer.

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I haven't had any treatment aimed at curing my current breast cancer.

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I had hepatitis C but am now cured, or I am being treated with undetectable levels.

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My nerve damage symptoms are mild or not present.

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I have not been treated with specific immune therapy drugs before.

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I can take care of myself and am up and about more than 50% of my waking hours.

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My cancer is at a specific stage and has not spread to distant parts of my body.

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I have had a biopsy to check the status of my lymph nodes.

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My breast cancer is triple-negative.

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My breast cancer is not at an advanced stage with significant lymph node involvement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Breast cancer event-free survival (BC-EFS)

Secondary study objectives

Distant relapse-free interval (DRFI)

Distant relapse-free survival (DRFS)

Incidence of adverse events

+7 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (shorter chemo-immunotherapy)Experimental Treatment7 Interventions

Patients receive docetaxel IV, carboplatin IV, and pembrolizumab IV on study. Patients then undergo surgery. Patients may receive pembrolizumab after surgery. Patients may optionally undergo collection of blood samples throughout the trial.

Group II: Arm I (usual chemo-immunotherapy)Active Control9 Interventions

Patients receive paclitaxel IV, carboplatin IV, and pembrolizumab IV on study. Patients then receive doxorubicin IV, cyclophosphamide IV, and pembrolizumab IV on study. Patients then undergo surgery. Patients may receive pembrolizumab after surgery. Patients may optionally undergo collection of blood samples throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Docetaxel

1995

Completed Phase 4

~6550