Clinical trial NCT01019616: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Primary Breast Cancer
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Science & Technology Commission
name: Peking Union Medical College Hospital
name: Chinese Academy of Medical Sciences
name: Peking University First Hospital
name: Peking University People's Hospital
name: Beijing Chao Yang Hospital
name: 307 Hospital of PLA
First posted: 2009-11-25
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: distant disease-free survival (DDFS)
timeFrame: 3 years after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: 307 Hospital of Pla
city: Beijing
country: China
facility: Beijing Cancer Hospital Breast Center
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital
city: Beijing
country: China
facility: Cancer Institution and Hospital.Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Peking University People'S Hospital
Study officials:
affiliation: Beijing Cancer Hospital Breast Center
name: Tao Ouyang, Doctor
role: STUDY_CHAIR
References: