Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy
Primary Purpose
Primary Breast Cancer
Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
paclitaxel/anthracycline
Sponsored by
About this trial
This is an interventional treatment trial for Primary Breast Cancer
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:
- Absolute neutrophil count (ANC) ≥1500/mm3
- Platelets ≥100,000/ mm3
- Hemoglobin ≥10 g/dL
Adequate hepatic and renal function with:
- Serum bilirubin ≤1.5×UNL
- Alkaline phosphatase and alanine aminotransferase (ALT) ≤2.5 x ULN. (≤5 x ULN is acceptable in the setting of hepatic metastasis)
- BUN between 1.7 and 8.3 mmol/L
- 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
Sites / Locations
- 307 Hospital of Pla
- Beijing Cancer Hospital Breast Center
- Beijing Chao-Yang Hospital
- Cancer Institution and Hospital.Chinese Academy of Medical Sciences
- Peking Union Medical College Hospital
- Peking University First Hospital
- Peking University People'S Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Chemotherapy
Control
Arm Description
Outcomes
Primary Outcome Measures
distant disease-free survival (DDFS)
Secondary Outcome Measures
Full Information
NCT ID
NCT01019616
First Posted
November 24, 2009
Last Updated
November 26, 2021
Sponsor
Tao OUYANG
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
1. Study Identification
Unique Protocol Identification Number
NCT01019616
Brief Title
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
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 4, 2011 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tao OUYANG
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
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chemotherapy
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
paclitaxel/anthracycline
Other Intervention Name(s)
Alternative Non-cross-resistant Adjuvant Chemotherapy
Intervention Description
standard chemotherapy regimen(containing paclitaxel or anthracycline) different from primary chemotherapy(containing anthracycline or paclitaxel)
Primary Outcome Measure Information:
Title
distant disease-free survival (DDFS)
Time Frame
3 years after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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:
Absolute neutrophil count (ANC) ≥1500/mm3
Platelets ≥100,000/ mm3
Hemoglobin ≥10 g/dL
Adequate hepatic and renal function with:
Serum bilirubin ≤1.5×UNL
Alkaline phosphatase and alanine aminotransferase (ALT) ≤2.5 x ULN. (≤5 x ULN is acceptable in the setting of hepatic metastasis)
BUN between 1.7 and 8.3 mmol/L
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tao Ouyang, Doctor
Organizational Affiliation
Beijing Cancer Hospital Breast Center
Official's Role
Study Chair
Facility Information:
Facility Name
307 Hospital of Pla
City
Beijing
Country
China
Facility Name
Beijing Cancer Hospital Breast Center
City
Beijing
Country
China
Facility Name
Beijing Chao-Yang Hospital
City
Beijing
Country
China
Facility Name
Cancer Institution and Hospital.Chinese Academy of Medical Sciences
City
Beijing
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Facility Name
Peking University First Hospital
City
Beijing
Country
China
Facility Name
Peking University People'S Hospital
City
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy
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