Clinical trial · Interventional
Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy
A Phase Ⅲ Study of Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy
NCT01019616CI-TRIAL-00055274unknownPhase 3ClinicalTrials.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 phase Ⅲ, multi-center, prospective, open-label, randomized,controlled study is to determine whether alternative non-cross-resistant adjuvant chemotherapy can increase distant disease free survival(DDFS) in operable patients non-response to primary 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 |
|---|---|---|---|
| Primary Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| paclitaxel/anthracycline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chemotherapy
- interventionNames
- Drug: paclitaxel/anthracycline
- type
- NO_INTERVENTION
- label
- Control
Primary outcomes (1)
- measure
- distant disease-free survival (DDFS)
- timeFrame
- 3 years after surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients, age ≦65 years * Biopsy proven lymph node positive, estrogen receptor- positive primary breast cancer * Must have completed a 4-cycle neo-adjuvant chemotherapy with a standard regimen(containing anthracycline or paclitaxel) * Must have undergone surgery to remove the primary tumor by either a mastectomy or enlarged local excision * Postoperative residual positive lymph nodes or G1/G2/G3 of Miller \& Payne Grading System * Adequate recovery from recent surgery * No history of other malignancies * No currently uncontrolled diseased or active infection * Not pregnant or breast feeding, and on appropriate birth control if of child-bearing potential * Adequate cardiovascular function reserve with a myocardial infarction within the past six month * Adequate hematologic function with: 1. Absolute neutrophil count (ANC) ≥1500/mm3 2. Platelets ≥100,000/ mm3 3. Hemoglobin ≥10 g/dL * Adequate hepatic and renal function with: 1. Serum bilirubin ≤1.5×UNL 2. Alkaline phosphatase and alanine aminotransferase (ALT) ≤2.5 x ULN. (≤5 x ULN is acceptable in the setting of hepatic metastasis) 3. BUN between 1.7 and 8.3 mmol/L 4. Cr between 40 and 110 umol/L * Knowledge of the investigational nature of the study and Ability to give informed consent * Ability and willingness to comply with study procedures. Exclusion Criteria: * Known or suspected distant metastases * Concurrent malignancy or history of other malignancy * Uncontrolled diseases(e.g., heart failure, myocardial infarction within 6 months, arrhythmia, unstable diabetes, hypercalcemia) or active infection * Geographical, social, or psychological problems that would compromise study compliance * Known or suspected hypersensitivity to anthracycline or paclitaxel
References
Publications (0)
Data not yet available
No reference posted for this study.