Shorter Chemo-Immunotherapy Without Anthracycline Drugs for Early-Stage Triple Negative Breast Cancer

Recruiting now · Phase 3

Conditions studied: Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Early Stage Triple-Negative Breast Carcinoma

In brief

This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage triple negative breast cancer. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Doxorubicin is an anthracycline chemotherapy drug that damages DNA and may kill cancer cells. Pembrolizumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Shorter treatment without anthracycline chemotherapy may work the same as the usual anthracycline chemotherapy treatment for early-stage triple negative breast cancer.

Key facts

Study ID

NCT05929768

Run by

SWOG Cancer Research Network

People needed

2400

Starts

2023-09-15

Expected to finish

2033-04-01

Last updated by the study team

2025-11-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have histologically confirmed estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and HER2-negative breast cancer (TNBC) defined as ER < 5%, PR < 5%, and HER2 negative (per 2020 American Society of Clinical Oncology [ASCO] College of American Pathologists [CAP] guidelines)
• NOTE: Participants with weakly ER or PR positive disease, defined as ER and/or PR between 1-4% by immunohistochemistry, are eligible if adjuvant endocrine therapy is not recommended/planned by the treating physician
• Participants must have American Joint Committee on Cancer (AJCC) 8 anatomic tumor clinical stage either
• T2-T4, N0, M0 or
• T1-T3, N1-2, M0
• Note: All participants with clinically suspicious nodes must undergo core needle biopsy or fine needle biopsy per standard clinical practice to pathologically confirm nodal status
• Participants must have breast and axillary imaging with mammogram and/or ultrasound and/or magnetic resonance imaging (MRI) within 49 days prior to randomization
• Note: Participants with bilateral invasive breast cancer are eligible if both breast cancers are ER-negative, PR-negative, and HER2-negative provided they meet the other eligibility criteria
• Participants must not have T4/N+, any N3, or inflammatory breast cancer
• Participants must not have metastatic disease (M1)
• Participants must not have received prior systemic therapy or radiation therapy with curative intent for the current breast cancer
• Participants must not have had previous definitive ipsilateral breast surgery for the current breast cancer
• Participants must not have current or anticipated use of other investigational agents while participating in this study
• Participants must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition as study agents
• Participants must not have severe hypersensitivity (>= grade 3) to pembrolizumab or any of its excipients
• Participants must not have received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137)
• Participants must not be currently participating in or have participated in a study of an investigational agent or used an investigational device within 28 days prior to randomization
• Participants must be >= 18 years old
• Participants must have Zubrod performance status of 0-2
• Participants with evidence of peripheral neuropathy must have it at =< grade 1, by Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0, within 28 days prior to randomization
• Participants must have a complete medical history and physical exam within 28 days prior to randomization
• Hemoglobin >= 9.0 g/dL or >= 5.6 mol/L (within 28 days prior to randomization)
• (Criteria must be met without erythropoietin dependency and without packed red blood cell transfusion within last 2 weeks)
• Leukocytes >= 3 x 10\^3/uL (within 28 days prior to randomization)
• Absolute neutrophil count >= 1.5 x 10\^3/uL (within 28 days prior to randomization)

Where it is running

• Anchorage Associates in Radiation Medicine — Anchorage, Alaska, United States (enrolling)
• Kaiser Permanente-Bellflower — Bellflower, California, United States (enrolling)
• Alaska Breast Care and Surgery LLC — Anchorage, Alaska, United States (enrolling)
• Alaska Oncology and Hematology LLC — Anchorage, Alaska, United States (enrolling)
• Alaska Women's Cancer Care — Anchorage, Alaska, United States (enrolling)
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States (enrolling)
• Katmai Oncology Group — Anchorage, Alaska, United States (enrolling)
• Providence Alaska Medical Center — Anchorage, Alaska, United States (enrolling)
• Fairbanks Memorial Hospital — Fairbanks, Alaska, United States (enrolling)
• Kingman Regional Medical Center — Kingman, Arizona, United States (enrolling)
• Cancer Center at Saint Joseph's — Phoenix, Arizona, United States (enrolling)
• Highlands Oncology Group - Fayetteville — Fayetteville, Arkansas, United States (enrolling)
• Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States (enrolling)
• NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas, United States (enrolling)
• CARTI Cancer Center — Little Rock, Arkansas, United States (enrolling)
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (enrolling)
• Highlands Oncology Group - Rogers — Rogers, Arkansas, United States (enrolling)
• Highlands Oncology Group — Springdale, Arkansas, United States (enrolling)
• Kaiser Permanente-Anaheim — Anaheim, California, United States (enrolling)
• Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande, California, United States (enrolling)
• PCR Oncology — Arroyo Grande, California, United States (enrolling)
• Sutter Auburn Faith Hospital — Auburn, California, United States (enrolling)
• Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn, California, United States (enrolling)
• Kaiser Permanente-Baldwin Park — Baldwin Park, California, United States (enrolling)
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States (enrolling)

Full record on ClinicalTrials.gov

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