SWOG S2212

Clinical Trial Title Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET)
Trial Status Open to Enrollment
Start Date 10/31/2023
Location Doctors & Locations
Trial Type Cancer - Adult Oncology
Specific Condition Breast Cancer
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.
Eligibility Criteria

Eligibility Criteria

Participants must be ≥ 18 years old.

Participants must have Zubrod Performance Status of 0-2

Participants must have histologically confirmed ER-negative, PR-negative, and HER2-negative breast cancer (TNBC) defined as ER<5%, PR<5%, and HER2 negative.

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 MRI within 49 days prior to randomization.

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 current or anticipated use of other investigational agents while participating in this study


IRB Number Central IRB
Notes Study Details | Shorter Chemo-Immunotherapy Without Anthracycline Drugs for Early-Stage Triple Negative Breast Cancer | ClinicalTrials.gov
Principal Investigator Mei Dong, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org