Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy
NCT ID: NCT01019616
Last Updated: 2021-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
400 participants
INTERVENTIONAL
2011-03-04
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chemotherapy
paclitaxel/anthracycline
standard chemotherapy regimen(containing paclitaxel or anthracycline) different from primary chemotherapy(containing anthracycline or paclitaxel)
Control
No interventions assigned to this group
Interventions
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paclitaxel/anthracycline
standard chemotherapy regimen(containing paclitaxel or anthracycline) different from primary chemotherapy(containing anthracycline or paclitaxel)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
FEMALE
No
Sponsors
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Beijing Municipal Science & Technology Commission
OTHER
Peking Union Medical College Hospital
OTHER
Chinese Academy of Medical Sciences
OTHER
Peking University First Hospital
OTHER
Peking University People's Hospital
OTHER
Beijing Chao Yang Hospital
OTHER
307 Hospital of PLA
OTHER
Tao OUYANG
OTHER
Responsible Party
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Tao OUYANG
Chairman of Breast Center
Principal Investigators
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Tao Ouyang, Doctor
Role: STUDY_CHAIR
Beijing Cancer Hospital Breast Center
Locations
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307 Hospital of Pla
Beijing, , China
Beijing Cancer Hospital Breast Center
Beijing, , China
Beijing Chao-Yang Hospital
Beijing, , China
Cancer Institution and Hospital.Chinese Academy of Medical Sciences
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
Peking University First Hospital
Beijing, , China
Peking University People'S Hospital
Beijing, , China
Countries
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Other Identifiers
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D09050703570904
Identifier Type: -
Identifier Source: org_study_id