NCT04437160RecruitingPhase 2
Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy
A Multicenter, Randomised, Open-label Phase II Study to Evaluate the Efficacy and Safety of Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Platinum-based Neoadjuvant Chemotherapy
Source: ClinicalTrials.gov · Last updated 18 Jun 2020 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study will evaluate the efficacy and safety of antharcycline-based adjuvant chemotherapy compared with observation in triple negative breast cancer (TNBC) patients with residual invasive disease after platinum and taxanes based neoadjuvant chemotherapy.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 286 (estimated)
- First submitted
- 5 Jun 2020
- Start date
- 1 Feb 2020
- Primary completion date
- 31 Jan 2026
- Lead sponsor
- Chinese Academy of Medical Sciences
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT04437160
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 286
- From 1 Feb 2020 to the primary completion date, 31 Jan 2026
- 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
- Previous neoadjuvant chemotherapy with anthracycline or other drugs (except platinum and taxanes).
- Previous neoadjuvant chemotherapy with platinum or taxanes alone.
- Patients have received other adjuvant therapy.
Other illness
- Prior history of other malignancy (except carcinoma in situ).
Other
- Comprehensive medical examinations have revealed distant metastases before randomization.
- Patients who are not suitable for anthracycline evaluated by investigators.
Who the study is looking for
- Patients with histologically confirmed invasive adenocarcinoma of the breast.
- Triple negative breast cancer: hormone receptor negative (ER \< 10% and PgR \< 10%) and HER2 negative (IHC 0/1+ or ISH non-amplified), as defined by the local pathology laboratory.
- Clinical stage at presentation: T1-4, N0-3, M0, with indications for neoadjuvant chemotherapy.
- Patient must have received platinum and taxanes neoadjuvant chemotherapy for at least 4 cycles and no tumor progression occurred.
- Patients should have undergone adequate tumor excision in the breast and lymph nodes after neoadjuvant chemotherapy.
- Residual invasive disease must be ≥1cm in the breast, and/or have positive axillary lymph nodes observed on pathologic exam after neoadjuvant chemotherapy.
- ECOG Performance Status: 0-1.
- Patients without severe heart, lung, liver and kidney disease.
- Adequate hematologic and end-organ function.
- No more than 6 weeks may elapse between definitive breast surgery and randomization.
Age in the registry: 18 years to 75 years · Sex: All · 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 |
|---|---|---|---|
| Cancer Hospital & Institute Chinese Academy of Medical Sciences (CAMS) Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.