Shorter Anthracycline-Free Chemo Immunotherapy in Early Triple-Negative Breast Cancer

What is the Purpose of this Study?

The purpose of this study is to compare the standard-of-care chemo-immunotherapy (carboplatin/paclitaxel followed by adriamycin/cyclophosphamide plus pembrolizumab, given in 6 months) treatment for early-stage, triple-negative breast cancer to a shorter non-anthracycline chemo-immunotherapy treatment (carboplatin docetaxel pembrolizumab, given in 4.5 months) that uses fewer drugs and a shorter course of treatment. Researchers aim to determine whether the shorter chemoimmunotherapy without anthracycline chemotherapy is as effective as the standard-of-care anthracycline chemoimmunotherapy treatment for early-stage, triple-negative breast cancer. The study will evaluate how well each treatment works to prevent cancer from returning. Researchers also want to learn whether the shorter chemo-immunotherapy improves patients’ quality of life and causes fewer side effects than the usual treatment. All chemotherapy and immunotherapy drugs used in this study are commonly used to treat triple-negative breast cancer. Participants will be assigned to 1 of 2 groups. Group 1 will receive the usual chemo-immunotherapy for triple-negative breast cancer. Group 2 will receive the study treatment using chemo-immunotherapy that is shorter and uses fewer drugs. After chemo-immunotherapy treatment, participants will undergo surgery.


Eligibility

  • * 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
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Where can I participate?

  • Cedars-Sinai Cancer at Beverly Hills (THO)
  • Cedars-Sinai Cancer at Hunt Cancer Center - TMPNCC (CSMC Affiliate)
  • Cedars-Sinai Cancer at SOCC
  • Cedars-Sinai Cancer at Valley Oncology
  • Huntington Hospital (CSMC Affiliate)


More about this Clinical Trial

What is the full name of this clinical trial?

S2212: Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer , A Randomized Phase III Study

Study Details
Disease Type/Condition

Breast

Principal Investigator

Yuan, Yuan

Co-Investigators

David Chan, Dorothy Park, Jin Sun Bitar, Maryliza El-Masry, Monica Mita, Niki Patel Tank, Philomena McAndrew, Swati Sikaria, Tiffany Shaw, Tina Wang

Age Group

Adult

Phase

III

IRB Number

STUDY00003042

ClinicalTrials.gov ID

NCT05929768

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Breast

Principal Investigator

Yuan, Yuan

Age Group

Adult

Phase

III

IRB Number

S2212

ClinicalTrials.gov ID

NCT05929768

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org