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

The purpose of this study is to assess whether participants with early stage TNBC randomized to receive anthracycline-free, taxane-platinum neoadjuvant chemotherapy with pembrolizumab have non-inferior breast cancer event-free survival (BC-EFS) compared to participants randomized to taxane-platinum-anthracycline neoadjuvant chemotherapy with pembrolizumab. cancer.

Age & Gender

  • 18 years ~ 99 years
  • Male, Female

Visit Availability

  • Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

If you decide to take part in this study, you will get 1 of 2 chemo-immunotherapy treatments before surgery. The treatments are: • Carboplatin and docetaxel chemotherapy with pembrolizumab for up to 6 cycles (Study approach). • Carboplatin and paclitaxel chemotherapy with pembrolizumab for up to 4 cycles followed by cyclophosphamide and doxorubicin with pembrolizumab for cycles 5 through 8 (Usual approach). After chemo-immunotherapy treatment, you will have surgery. After surgery, immunotherapy with the drug pembrolizumab is recommended for all patients. After you finish chemo-immunotherapy, surgery, and radiation therapy (if it's part of your treatment plan). Your doctor will continue to follow your condition for at least every 6 months for 5 years and watch you for side effects. This means you will keep seeing your doctor until 5 years after you started the study.

Total length of participation:
After you finish chemo-immunotherapy, surgery, and radiation therapy (if it's part of your treatment plan). Your doctor will continue to follow your condition for at

Looking for Healthy Volunteers

Requirements for healthy volunteers are different than for those with a specific condition. If you are interested in becoming a healthy volunteer for this study, use the below categories to determine if you are able to participate.

Able to participate:

  • You have been diagnosed with triple negative breast cancer that is not metastatic
  • You have not received systemic therapy or radiation for your breast cancer
  • You are not currently participating in another clinical trial with an investigational agent or device within 28 days of starting this study

Not eligible if:

  • You have been diagnosed with inflammatory breast cancer.
  • You have received breast surgery for your current breast cancer.
  • You have uncontrolled diabetes
  • You have had major surgery with 14 days of starting the study
  • You are pregnant or nursing

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Yara Abdou
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Breast)

IRB Number

25-0325

ClinicalTrials.gov

NCT# 05929768

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