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

• Status: Unknown status
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tao OUYANG
• Collaborators: 307 Hospital of PLA; Beijing Chao Yang Hospital; Beijing Municipal Science & Technology Commission; Chinese Academy of Medical Sciences; Peking Union Medical College Hospital; Peking University First Hospital; Peking University People's Hospital
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

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