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

A Prospective, Phase II Trial Using Circulating Tumor DNA to Initiate Post-operation Boost Therapy After Neoadjuvant Chemotherapy in Triple-negative Breast Cancer

This study is testing if using a blood test to find leftover cancer DNA after surgery can help doctors choose better treatments for people with triple-negative breast cancer who are at risk of relapse.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 460 (estimated)
• Ages: 18 Years to 80 Years
• Sex: Female
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Academic / other)
• Drugs / interventions: tislelizumab, chemotherapy
• Locations: 1 site (Guandong, Guangdong)
• Trial ID: NCT04501523 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals with histologically confirmed stage II-III triple-negative breast cancer who are ctDNA positive after neoadjuvant chemotherapy.

Not a fit: Patients who do not have triple-negative breast cancer or those who are ctDNA negative may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more tailored and effective treatment strategies for patients with triple-negative breast cancer.

How similar studies have performed: While the use of ctDNA in cancer treatment is gaining traction, this specific approach in TNBC is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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 this trial is running

Guandong, Guangdong

• Sunyat-sen Memorial Hospital — Guandong, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Qiang Liu, MD — Sunyat-sen Memorial Hospital
• Study coordinator: Shunying Li, MD

Conditions Triple-negative Breast Cancer