Randomized Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment in Receptor-negative Patients
NCT ID: NCT00309569
Last Updated: 2020-10-14
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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COMPLETED
PHASE3
429 participants
INTERVENTIONAL
1991-10-31
2000-09-30
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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A (pre- + postoperative chemotherapy)
3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil) followed by surgery. Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.
Cyclophosphamide
Cyclophosphamide 600mg/m2
Methotrexate
Methotrexate 40mg/m2
Fluorouracil
Fluorouracil 600mg/m2
Epirubicin
Epirubucin 60mg/m2 (only node-positive patients)
Surgery
Surgery
B (conventional postoperative chemotherapy)
Surgery followed by 3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil). Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.
Cyclophosphamide
Cyclophosphamide 600mg/m2
Methotrexate
Methotrexate 40mg/m2
Fluorouracil
Fluorouracil 600mg/m2
Epirubicin
Epirubucin 60mg/m2 (only node-positive patients)
Surgery
Surgery
Interventions
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Cyclophosphamide
Cyclophosphamide 600mg/m2
Methotrexate
Methotrexate 40mg/m2
Fluorouracil
Fluorouracil 600mg/m2
Epirubicin
Epirubucin 60mg/m2 (only node-positive patients)
Surgery
Surgery
Eligibility Criteria
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Inclusion Criteria
* Estrogen receptor-negative status
* Age: \< 70 years
* WHO Performance Status \< 2
* Laboratory parameters
1. hematopoiesis: \> 3500/mm3 leukocytes, \> 100,000/mm3 thrombocytes
2. renal function: creatinin \< 1.5mg%
3. hepatic function: GOT max. 2.5 x UNL
4. bilirubin: \< 2.0 mg %
5. metabolic parameters: Na, Ca, K in normal range
* \</= 4 weeks interval since surgery
* Informed consent
Exclusion Criteria
* Other preoperative tumor-specific radiotherapy, chemotherapy or endocrine treatment
* Pregnancy or lactation
* General contraindication against cytostatic treatment
* T4 cancer; inflammatory disease, simultaneous or sequential bilateral breast cancer
* Lacking compliance or understanding of disease
* Serious concomitant disease
* Second carcinoma or status post second carcinoma (except for treated squamous cell carcinoma of the skin or cervical carcinoma in situ)
18 Years
80 Years
FEMALE
No
Sponsors
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Austrian Breast & Colorectal Cancer Study Group
NETWORK
Responsible Party
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Principal Investigators
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Raimund Jakesz, MD
Role: PRINCIPAL_INVESTIGATOR
Austrian Breast & Colorectal Cancer Study Group
Related Links
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Related Info
Other Identifiers
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ABCSG-7
Identifier Type: -
Identifier Source: org_study_id
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