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

Clinical Trial Title

Shorter Chemo-Immunotherapy Without Anthracycline Drugs for Early-Stage Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study

National Clinical Trial Number:

NCT05929768

Contact Information

RUSH Cancer Center Clinical Trials Office

Clinical Trial Protocol Description:

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.

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

  • Have histologically confirmed estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and HER2-negative breast cancer.
  • Have American Joint Committee on Cancer 8 anatomic tumor clinical stage either of the following:
    • T2-T4, N0, M0
    • T1-T3, N1-2, M0
  • Have breast and axillary imaging with mammogram and/or ultrasound and/or magnetic resonance imaging (MRI) within 49 days prior to randomization.

You will be excluded from the study if any of the following criteria apply to you:

  • Have T4/N+, any N3, or inflammatory breast cancer.
  • Have metastatic disease (M1).
  • Have received prior systemic therapy or radiation therapy with curative intent for the current breast cancer.
  • Have had previous definitive ipsilateral breast surgery for the current breast cancer.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.

Study Details

Clinical Trial Investigator

Lydia Usha, MD

Contact Information

RUSH Cancer Center Clinical Trials Office

Clinical Trial Location

RUSH University Medical Center

Location

RUSH University Medical Center

1620 W Harrison St
Chicago, IL 60612

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