About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Carboplatin
  • Cyclophosphamide
  • Docetaxel
  • Doxorubicin
  • Paclitaxel
  • Pembrolizumab
  • Quality-of-Life Assessment
  • Questionnaire Administration
  • Surgical Procedure

Treatment groups

2,400 Participants
are divided into 2 treatment groups

Locations

963
Mexico
Instituto Nacional De Cancerologia de Mexico14080, Mexico CityTlalpan, Mexico
Puerto Rico
Cancer Center-Metro Medical Center Bayamon00959-5060, Bayamón Puerto Rico
Puerto Rico Hematology Oncology Group00961, Bayamón Puerto Rico
Doctors Cancer Center00674, Manati Puerto Rico

Sponsors and collaborators

SWOG Cancer Research Network

Lead sponsor

National Cancer Institute (NCI)

Collaborator