NCT04501523 A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After NAC in TNBC
| NCT ID | NCT04501523 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
| Condition | Triple-negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 460 participants |
| Start Date | 2020-08-03 |
| Primary Completion | 2027-08 |
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 460 participants in total. It began in 2020-08-03 with a primary completion date of 2027-08.
⚠ 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
Positive circulating tumor DNA(ctDNA) status is associated with worse prognosis in breast cancer, especially triple-negative breast cancer(TNBC). Our trial aims to improve the outcome of TNBC patients by using ctDNA to identify patients with high relapse risk. ctDNA positive patients will be randomized to receive boost therapy or standard therapy indicated in NCCN guidelines after NAC.
Eligibility Criteria
Inclusion Criteria: * Must have histologically or cytologically confirmed triple negative (ER-/PR-/HER2-) invasive breast cancer, clinical stage II-III at diagnosis (AJCC 6th edition) based on initial evaluation by physical examination and/or breast imaging prior to study registration.ER and PR will be considered negative if ≤ 1% of cells stain weakly positive. HER2 will be considered negative if scored 0 or 1+ by immunohistochemistry (IHC) or 2+ by IHC associated with a fluorescence in situ hybridization (FISH) ratio of \< 2.0 or \< 6 copies per cell. * 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: * Previously participated in other interventional trials * 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
Contact & Investigator
Qiang Liu, MD
PRINCIPAL INVESTIGATOR
Sunyat-sen Memorial Hospital
Frequently Asked Questions
Who can join the NCT04501523 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 80 Years, studying Triple-negative 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 NCT04501523 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 NCT04501523 currently recruiting?
Yes, NCT04501523 is actively recruiting participants. Contact the research team at lishunying@foxmail.com for enrollment information.
Where is the NCT04501523 trial being conducted?
This trial is being conducted at Guandong, China.
Who is sponsoring the NCT04501523 clinical trial?
NCT04501523 is sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. The principal investigator is Qiang Liu, MD at Sunyat-sen Memorial Hospital. The trial plans to enroll 460 participants.
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