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Recruiting NCT04501523

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

Phase II Interventional Triple-negative Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tislelizumab, capecitabine.
Who it may be relevant to
Registry conditions: Triple-negative Breast Cancer. Basic parameters: 18 years — 80 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Tislelizumab
    200mg, q3w, for 1 year
  • Drug capecitabine
    600-750 mg/m2 PO Bid，continuous, for 1 year

Primary outcome measures

  • 5 years Disease free survival(DFS) [Time frame: 60 months]
Secondary outcome measures (8)
  • 5 years overall survival(OS) [Time frame: 60 months]
  • pathological complete remission(pCR) rate [Time frame: 12 months]
  • brain metastasis rate [Time frame: 60 months]
  • objective response rate(ORR) [Time frame: 12 months]
  • Number of Patients with Adverse Events as a Measure of Safety and Tolerability [Time frame: 12 months]
  • 10 years DFS [Time frame: 120 months]
  • 10 years OS [Time frame: 120 months]
  • Relapse and metastasis rate [Time frame: 24 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sunyat-sen Memorial Hospital — Guandong

Identifiers

NCT: NCT04501523 · SunYatsenU2H-LQ3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗