NCT04501523RecruitingPhase 2
A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After NAC in TNBC
A Prospective, Phase II Trial Using Circulating Tumor DNA to Initiate Post-operation Boost Therapy After Neoadjuvant Chemotherapy in Triple-negative Breast Cancer
Source: ClinicalTrials.gov · Last updated 21 Feb 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 460 (estimated)
- First submitted
- 3 Aug 2020
- Start date
- 3 Aug 2020
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT04501523
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 460
- From 3 Aug 2020 to the primary completion date, 31 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously participated in other interventional trials
- Unable to receive standard NAC and subsequent radiotherapy(if needed)
Other illness
- Previous malignancy within 3 years of breast cancer diagnosis
- Active autoimmune disease
Other
- Pregnancy or breastfeeding
- No written consent
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sunyat-sen Memorial Hospital Coordinator of this site? Confirm its status | Guandong | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.