Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy

Tao OUYANG

Status and phase

Unknown

Phase 3

Conditions

Primary Breast Cancer

Treatments

Drug: paclitaxel/anthracycline

Study type

Interventional

Funder types

Other

Identifiers

NCT01019616

D09050703570904

Details and patient eligibility

About

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.

Enrollment

400 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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