Randomized Study Comparing Pre- and Postoperative Vs. Conventional Adjuvant Treatment in Receptor-Negative Patients
This study has been completed.
Sponsor:
Austrian Breast & Colorectal Cancer Study Group
Information provided by:
Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00309569
First received: March 31, 2006
Last updated: NA
Last verified: October 1999
History: No changes posted
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Purpose
Primarily, this clinical investigation compared overall survival and recurrence-free survival in patients with hormone receptor-negative breast cancer treated with pre- and postoperative chemotherapy vs. conventional postoperative treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Early Stage Breast Cancer |
Drug: Cyclophosphamide Drug: Methotrexate Drug: Fluorouracil Drug: Epirubicine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase III Study Comparing Pre- and Postoperative Vs. Conventional Adjuvant Treatment Hormone Receptor-Negative Breast Cancer Patients |
Resource links provided by NLM:
Further study details as provided by Austrian Breast & Colorectal Cancer Study Group:
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with bioptically verified breast cancer
- Estrogen receptor-negative status
- Age: < 70 years
- WHO Performance Status < 2
Laboratory parameters
- hematopoiesis: > 3500/l leukocytes, > 100,000/l thrombocytes
- renal function: creatinin < 1.5mg%
- hepatic function: GOT 2.5 x UNL
- bilirubin: < 2.0 mg %
- metabolic parameters: Na, Ca, K in normal range
- </= 4 weeks interval since surgery
- Informed consent
Exclusion Criteria:
- Patients with locally inoperable cancer, M1
- 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)
Contacts and Locations More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00309569 History of Changes |
| Other Study ID Numbers: | ABCSG-7 |
| Study First Received: | March 31, 2006 |
| Last Updated: | March 31, 2006 |
| Health Authority: | Austria: Federal Ministry for Health and Women |
Keywords provided by Austrian Breast & Colorectal Cancer Study Group:
|
Cyclophosphamide Methotrexate Fluorouracil Epirubicine Breast Cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Fluorouracil Methotrexate Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses |
Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antimetabolites Antimetabolites, Antineoplastic Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013