Clinical trial · Interventional
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
NCT04437160CI-TRIAL-00045597recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Epirubicin or Pirarubicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Adjuvant chemotherapy
- description
- Adjuvant chemotherapy for triple negative breast cancer with residual invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after taxanes and platinum based neoadjuvant chemotherapy. Adjuvant chemotherapy regiments: Epirubicin 80-90mg/m2 IV or Pirarubicin 50mg/m2 IV + Cyclophosphamide 600mg/m2 IV, q21d\*4cycles.
- interventionNames
- Drug: Epirubicin or Pirarubicin
- Drug: Cyclophosphamide
- type
- NO_INTERVENTION
- label
- Observation
- description
- No adjuvant chemotherapy for triple negative breast cancer with residual invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after taxanes and platinum based neoadjuvant chemotherapy.
Primary outcomes (1)
- measure
- RFS
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Comprehensive medical examinations have revealed distant metastases before randomization. * Patients who are not suitable for anthracycline evaluated by investigators. * Prior history of other malignancy (except carcinoma in situ).
References
Publications (0)
Data not yet available
No reference posted for this study.