Clinical trial · Interventional
Study of Optimizing Neoadjuvant Regimens in Subtypes of Breast Cancer
Phase 2 Randomized Study of Different Neoadjuvant Regimens in Subtypes of Breast Cancer
NCT02041338CI-TRIAL-00016155unknownPhase 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)
There are no standard neodjuvant regimens adapted according to the different subtypes of breast cancer. This is a phase 2, randomized study to evaluate several regimens in different subtypes of breast cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Neoadjuvant Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epirubicin and Paclitaxel | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Paclitaxel and carboplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Luminal subtype test
- description
- Paclitaxel 175mg/m2, every 2 weeks as a cycle for 4-6 cycles
- interventionNames
- Drug: Paclitaxel
- type
- ACTIVE_COMPARATOR
- label
- Luminal subtype control
- description
- Epirubicin 75mg/m2 plus paclitaxel 175mg/m2 every 3 weeks as a cycle for 4-6 cycles
- interventionNames
- Drug: Epirubicin and Paclitaxel
- type
- EXPERIMENTAL
- label
- Her2 positive subtype test
- description
- Paclitaxel 175mg/m2 plus carboplatin AUC 4 with or without trastuzumab every 2 weeks as a cycle for 4-6 cycles
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Stage IIa-IIIc breast cancer patients plan to receive neoadjuvant chemotherapy * Patients have enough tissue sample to do IHC test for subtype classification * Patients have at least one measurable lesion according to RECIST1.1 * KPS≥80 * No prior treatment for breast cancer * Adequate bone marrow (neutrophil count ≥1500 ml and platelet count ≥100,000 ml), renal (serum creatinine \<1.5 times the upper limit of normal \[ULN\] or a creatinine clearance of ≥60 ml/minute), hepatic (total bilirubin ≤1.5 ULN; alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase ≤2.5 ULN), and cardiac function (assessed by electrocardiogram or thoracic radiography) were required. Exclusion Criteria: * Fertile women were excluded if pregnant or lactating or if they were not using adequate contraception. * Previous chemotherapy for breast cancer. * history of other serious illness (e.g. congestive heart failure, angina pectoris, uncontrolled hypertension or arrhythmia, clinically significant neurologic or psychiatric disorders, uncontrolled serious infection, AIDS), had an organ allograft, severe gastrointestinal disorder, or other neoplasias (except for in situ cervical cancer, non-melanoma skin cancer, or previous diagnosis of cancer with no evidence of disease for \>10 years).
References
Publications (0)
Data not yet available
No reference posted for this study.