NCT04803539 A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After Adjuvant Chemotherapy in TNBC
| NCT ID | NCT04803539 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 260 participants |
| Start Date | 2021-04-01 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 260 participants in total. It began in 2021-04-01 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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/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
Contact & Investigator
Qiang Liu, PhD
PRINCIPAL INVESTIGATOR
Sunyat-sen Memorial Hospital
Frequently Asked Questions
Who can join the NCT04803539 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 80 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04803539 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04803539 currently recruiting?
Yes, NCT04803539 is actively recruiting participants. Contact the research team at lishunying@foxmail.com for enrollment information.
Where is the NCT04803539 trial being conducted?
This trial is being conducted at Guandong, China.
Who is sponsoring the NCT04803539 clinical trial?
NCT04803539 is sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. The principal investigator is Qiang Liu, PhD at Sunyat-sen Memorial Hospital. The trial plans to enroll 260 participants.
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