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

Recruiting Phase 2 Phase 3 Interventional Study
Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 80
Sex
Female
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
260 (estimated)
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Other
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About This Trial

Circulating tumor DNA (ctDNA) has been demonstrated to be an effective prognostic marker in breast cancer. Various studies have shown that early TNBC breast cancer patients with positive ctDNA have high risk of cancer recurrence and worse prognosis. This study aimed to identify TNBC patients with positive ctDNA and initiate boost therapy in these high risk patients.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Patient is ≥ 18 years-old at the time of consent to participate this trial * Stage II - III primary triple negative breast cancer patients(TNBC), TNBC is defined as ER \<=1%, PR \<=1%;HER2 receptor IHC=1, or IHC=2 and FISH negative. * positive ctDNA after curative surgery and/…
Contacts

Shunying Li, MD

86-020-34071156

lishunying@foxmail.com

CONTACT

Qiang Liu, PhD

86-020-34071157

victorlq@hotmail.com

CONTACT