Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01019616
Recruitment Status : Unknown
Verified January 2019 by Tao OUYANG, Peking University.
Recruitment status was:  Active, not recruiting
First Posted : November 25, 2009
Last Update Posted : January 18, 2019
Sponsor:
Collaborators:
Beijing Municipal Science & Technology Commission
Peking Union Medical College Hospital
Chinese Academy of Medical Sciences
Peking University First Hospital
Peking University People's Hospital
Beijing Chao Yang Hospital
307 Hospital of PLA
Information provided by (Responsible Party):
Tao OUYANG, Peking University

Tracking Information
First Submitted Date  ICMJE November 24, 2009
First Posted Date  ICMJE November 25, 2009
Last Update Posted Date January 18, 2019
Actual Study Start Date  ICMJE March 4, 2011
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2009)
distant disease-free survival (DDFS) [ Time Frame: 3 years after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy
Official Title  ICMJE A Phase Ⅲ Study of Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Primary Breast Cancer
Intervention  ICMJE Drug: paclitaxel/anthracycline
standard chemotherapy regimen(containing paclitaxel or anthracycline) different from primary chemotherapy(containing anthracycline or paclitaxel)
Other Name: Alternative Non-cross-resistant Adjuvant Chemotherapy
Study Arms  ICMJE
  • Experimental: Chemotherapy
    Intervention: Drug: paclitaxel/anthracycline
  • No Intervention: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: November 24, 2009)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01019616
Other Study ID Numbers  ICMJE D09050703570904
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tao OUYANG, Peking University
Study Sponsor  ICMJE Tao OUYANG
Collaborators  ICMJE
  • Beijing Municipal Science & Technology Commission
  • Peking Union Medical College Hospital
  • Chinese Academy of Medical Sciences
  • Peking University First Hospital
  • Peking University People's Hospital
  • Beijing Chao Yang Hospital
  • 307 Hospital of PLA
Investigators  ICMJE
Study Chair: Tao Ouyang, Doctor Beijing Cancer Hospital Breast Center
PRS Account Peking University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP