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Recruiting Phase 2

A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After NAC in TNBC

NCT04501523 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2020-08-03
Last updated
2023-02-21

Condition(s) studied

Triple-negative Breast Cancer

Investigational drug(s) / intervention(s)

Tislelizumab →capecitabine →

Tislelizumab: 200mg, q3w, for 1 year

capecitabine: 600-750 mg/m2 PO Bid,continuous, for 1 year

Study summary

Positive circulating tumor DNA(ctDNA) status is associated with worse prognosis in breast cancer, especially triple-negative breast cancer(TNBC). Our trial aims to improve the outcome of TNBC patients by using ctDNA to identify patients with high relapse risk. ctDNA positive patients will be randomized to receive boost therapy or standard therapy indicated in NCCN guidelines after NAC.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 5 years Disease free survival(DFS) — 60 months
    From diagnosis to 5yrs or DFS events; To determine 5-year disease free survival in ctDNA positive participants with confirmed triple negative breast cancer (TNBC) treated with a boost therapy or standard of care following preoperative chemotherapy

Trial sites (1)

FacilityCityRegionStatus
Sunyat-sen Memorial Hospital Guandong Guangdong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04501523 on ClinicalTrials.gov ↗ ← All trials in China