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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Peking University
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
ClinicalTrials.gov Identifier:
NCT01019616
First received: November 24, 2009
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Primary Breast Cancer
Drug: paclitaxel/anthracycline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase Ⅲ Study of Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy

Resource links provided by NLM:


Further study details as provided by Peking University:

Primary Outcome Measures:
  • distant disease-free survival (DDFS) [ Time Frame: 3 years after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemotherapy 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
No Intervention: Control

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01019616

Contacts
Contact: Tao Ouyang, Doctor 0086-10-88196695 ouyanghongtao@263.net

Locations
China
307 Hospital of Pla Recruiting
Beijing, China
Beijing Cancer Hospital Breast Center Recruiting
Beijing, China
Beijing Chao-Yang Hospital Recruiting
Beijing, China
Cancer Institution and Hospital.Chinese Academy of Medical Sciences Recruiting
Beijing, China
Peking Union Medical College Hospital Recruiting
Beijing, China
Peking University First Hospital Recruiting
Beijing, China
Peking University People'S Hospital Recruiting
Beijing, China
Sponsors and Collaborators
Tao OUYANG
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
Study Chair: Tao Ouyang, Doctor Beijing Cancer Hospital Breast Center
  More Information

No publications provided

Responsible Party: Tao OUYANG, Chairman of Breast Center, Peking University
ClinicalTrials.gov Identifier: NCT01019616     History of Changes
Other Study ID Numbers: D09050703570904
Study First Received: November 24, 2009
Last Updated: June 16, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 27, 2014