Using ctDNA to guide therapy after surgery in triple negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of circulating tumor DNA (ctDNA) as a prognostic marker to identify high-risk patients with stage II-III triple negative breast cancer (TNBC) after they have undergone surgery and adjuvant chemotherapy. Patients with positive ctDNA will receive additional boost therapy with capecitabine, either alone or in combination with camrelizumab and apatinib. The study aims to improve outcomes for these patients by tailoring therapy based on ctDNA results. Blood samples will be collected every three months for five years to monitor ctDNA levels.

Why it matters

Who can join: the full rules

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/or adjuvant chemotherapy
* ECOG 0-2
* If indicated, patient agree to receive adjuvant radiotherapy according to the institutional guidelines
* Patient receives adjuvant chemotherapy according to the NCCN guidelines
* Patient has available tumor tissue from the surgical specimen for next generation sequencing(NCS)
* Patient agrees to give blood samples for ctDNA tests every 3 months in 5 years

Exclusion Criteria:

* Patient has previously received any PD1/PDL1 blockage treatment
* Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial
* Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition)
* Patient participates another interventional clinical trial
* Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 3 years before randomization
* Patient with autoimmune disease preventing the use of camrelizumab
* Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol

Where it's running

• Sunyat-sen Memorial Hospital
  Guandong, Guangdong, China Recruiting

Study contacts

• Principal investigator: Qiang Liu, PhD — Sunyat-sen Memorial Hospital
• Study coordinator: Shunying Li, MD
• Email: lishunying@foxmail.com
• Phone: 86-020-34071156

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.