A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After NAC in TNBC
NCT ID: NCT04501523
Last Updated: 2023-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
460 participants
INTERVENTIONAL
2020-08-03
2032-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
ctDNA positive, non-pCR Intervention: Tislelizumab(anti-PD1 antibody) combined with capecitabine
Tislelizumab
200mg, q3w, for 1 year
capecitabine
600-750 mg/m2 PO Bid，continuous, for 1 year
B
ctDNA positive, non-pCR Intervention: capecitabine(standard care)
capecitabine
600-750 mg/m2 PO Bid，continuous, for 1 year
C
ctDNA positive, pCR Intervention: capecitabine
capecitabine
600-750 mg/m2 PO Bid，continuous, for 1 year
D
Follow up(standard care)
No interventions assigned to this group
Interventions
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Tislelizumab
200mg, q3w, for 1 year
capecitabine
600-750 mg/m2 PO Bid，continuous, for 1 year
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
FEMALE
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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Liu Qiang
Doctor
Principal Investigators
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Qiang Liu, MD
Role: PRINCIPAL_INVESTIGATOR
Sunyat-sen Memorial Hospital
Locations
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Sunyat-sen Memorial Hospital
Guandong, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SunYatsenU2H-LQ3
Identifier Type: -
Identifier Source: org_study_id
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