NCT04501523

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P75+ for phase_2

Timeline
75mo left

Started Aug 2020

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Aug 2020Aug 2032

First Submitted

Initial submission to the registry

August 3, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

August 3, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2020

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2032

Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

7 years

First QC Date

August 3, 2020

Last Update Submit

February 16, 2023

Conditions

Triple-negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 5 years Disease free survival(DFS)

    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

    60 months

Secondary Outcomes (8)

  • 5 years overall survival(OS)

    60 months

  • pathological complete remission(pCR) rate

    12 months

  • brain metastasis rate

    60 months

  • objective response rate(ORR)

    12 months

  • Number of Patients with Adverse Events as a Measure of Safety and Tolerability

    12 months

  • +3 more secondary outcomes

Study Arms (4)

A

EXPERIMENTAL

ctDNA positive, non-pCR Intervention: Tislelizumab(anti-PD1 antibody) combined with capecitabine

Drug: TislelizumabDrug: capecitabine

B

ACTIVE COMPARATOR

ctDNA positive, non-pCR Intervention: capecitabine(standard care)

Drug: capecitabine

C

EXPERIMENTAL

ctDNA positive, pCR Intervention: capecitabine

Drug: capecitabine

D

NO INTERVENTION

Follow up(standard care)

Interventions

TislelizumabDRUG

200mg, q3w, for 1 year

A
capecitabineDRUG

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

ABC

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunyat-sen Memorial Hospital

Guandong, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

tislelizumabCapecitabine

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Qiang Liu, MD

    Sunyat-sen Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shunying Li, MD

CONTACT

+86-15915939702lishunying@foxmail.com

Yudong Li, MD

CONTACT

020-34071156910870698@qq.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 3, 2020

First Posted

August 6, 2020

Study Start

August 3, 2020

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2032

Last Updated

February 21, 2023

Record last verified: 2023-02

Locations

CN(1)