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

Recruiting now · Phase 2/Phase 3

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID: NCT04803539
Run by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
People needed: 260
Starts: 2021-04-01
Expected to finish: 2033-09-01
Last updated by the study team: 2023-02-21

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 is running

Sunyat-sen Memorial Hospital — Guandong, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.