Description:
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.
Title
- Brief Title: Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy
- Official Title: A Phase Ⅲ Study of Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy
Clinical Trial IDs
- ORG STUDY ID:
D09050703570904
- NCT ID:
NCT01019616
Conditions
Interventions
Drug | Synonyms | Arms |
---|
paclitaxel/anthracycline | Alternative Non-cross-resistant Adjuvant Chemotherapy | Chemotherapy |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Chemotherapy | Experimental | | |
Control | No Intervention | | |
Eligibility Criteria
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
Maximum Eligible Age: | 65 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | distant disease-free survival (DDFS) |
Time Frame: | 3 years after surgery |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Unknown status |
Lead Sponsor: | Tao OUYANG |
Last Updated
January 18, 2019