Using ctDNA to guide therapy after surgery in triple-negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to improve outcomes for patients with triple-negative breast cancer (TNBC) by utilizing circulating tumor DNA (ctDNA) to identify those at high risk of relapse after neoadjuvant chemotherapy (NAC). Patients who test positive for ctDNA will be randomized to receive either a boost therapy or standard therapy as per NCCN guidelines following their surgery. The study focuses on evaluating the effectiveness of this personalized approach in enhancing treatment outcomes for TNBC patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Must have histologically or cytologically confirmed triple negative (ER-/PR-/HER2-) invasive breast cancer, clinical stage II-III at diagnosis (AJCC 6th edition) based on initial evaluation by physical examination and/or breast imaging prior to study registration.ER and PR will be considered negative if ≤ 1% of cells stain weakly positive. HER2 will be considered negative if scored 0 or 1+ by immunohistochemistry (IHC) or 2+ by IHC associated with a fluorescence in situ hybridization (FISH) ratio of \< 2.0 or \< 6 copies per cell.
* Must receive preoperative (neoadjuvant) chemotherapy. NOTE: Acceptable preoperative regimens include those recommended by NCCN guidelines. Participants who received preoperative therapy as part of a clinical trial may enroll.
* ctDNA positive at baseline, after NAC or after surgery
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
* Written informed consent to provide research blood samples and tumor samples
* Patients must be willing to have frequent blood tests (every 3 months ) and receive a 12 month course of tislelizumab if randomised to tislelizumab treatment on ctDNA detection
* No evidence of distant metastatic disease on staging scans conducted at the time of diagnosis

Exclusion Criteria:

* Previously participated in other interventional trials
* Previous malignancy within 3 years of breast cancer diagnosis
* Pregnancy or breastfeeding
* No written consent
* Unable to receive standard NAC and subsequent radiotherapy(if needed)
* Active autoimmune disease

Where it's running

• Sunyat-sen Memorial Hospital
  Guandong, Guangdong, China Recruiting

Study contacts

• Principal investigator: Qiang Liu, MD — Sunyat-sen Memorial Hospital
• Study coordinator: Shunying Li, MD
• Email: lishunying@foxmail.com
• Phone: +86-15915939702

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Granzyme B-PET to see if immunotherapy works in TNBC

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.