Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy
Conditions
Primary Breast Cancer
Conditions: official terms
Breast Neoplasms
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: paclitaxel/anthracycline
Type: Drug
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Female
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
Locations
307 Hospital of Pla
Beijing, China
Status: Recruiting
Beijing Cancer Hospital Breast Center
Beijing, China
Status: Recruiting
Beijing Chao-Yang Hospital
Beijing, China
Status: Recruiting
Cancer Institution and Hospital.Chinese Academy of Medical Sciences
Beijing, China
Status: Recruiting
Peking Union Medical College Hospital
Beijing, China
Status: Recruiting
Peking University First Hospital
Beijing, China
Status: Recruiting
Peking University People'S Hospital
Beijing, China
Status: Recruiting
Start Date
December 2010
Completion Date
June 2017
Sponsors
Tao OUYANG
Source
Peking University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page