Clinical trial · Interventional
Induction Preoperative Chemotherapy for Patients With Locally Advanced Triple Negative Breast Cancer
Phase 2 Study of Two Consequent Chemotherapy Regimens as Induction Preoperative Therapy for Patients With Locally Advanced Triple Negative Breast Cancer
NCT01969032CI-TRIAL-00015992completedPhase 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)
The purpose of this study is to increase survival of patients with locally advanced triple-negative breast cancer using two consequent induction preoperative chemotherapy regimens.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel, Carboplatinum, Doxorubicin, Endoxan, Capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 2 consequent anthracycline-taxane based chemotherapy regimens
- description
- Paclitaxel 60 mg/m2 IV weekly plus Carboplatinum AUC2 IV weekly for 9 weeks, then Doxorubicin 25 mg/m2 IV weekly plus Endoxan 50 mg per os q.i.d. plus Capecitabine 500 mg t.i.d for 9 weeks
- interventionNames
- Drug: Paclitaxel, Carboplatinum, Doxorubicin, Endoxan, Capecitabine
Primary outcomes (1)
- measure
- The pathological complete response rate to two consequent induction preoperative chemotherapy regimens
- timeFrame
- After 18 weeks of induction chemotherapy
Secondary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients, age ≥18 years≤75 * Histologically confirmed invasive ER-, PR-, and HER2-negative (triple-negative) adenocarcinoma of the breast * Stages Т2-4 N 2-3 M0 * Signed inform consent Exclusion Criteria: * Previous treatment for this breast cancer * History of malignancy treated with curative intent within the previous 5 years with the exception of skin cancer, cervical carcinoma in situ, or follicular thyroid cancer. Patients with previous invasive cancers (including breast cancer) are eligible if the treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease * Pregnancy or breast-feeding * Serious concurrent diseases or conditions that may alter chemotherapy conduction
References
Publications (0)
Data not yet available
No reference posted for this study.