Randomized Study Comparing Pre- and Postoperative Vs. Conventional Adjuvant Treatment in Receptor-Negative Patients

This study has been completed.

First Received: March 31, 2006 No Changes Posted

Sponsored by:	Austrian Breast & Colorectal Cancer Study Group
Information provided by:	Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier:	NCT00309569

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 III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Cyclophosphamide Fluorouracil Methotrexate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	A Randomized Phase III Study Comparing Pre- and Postoperative Vs. Conventional Adjuvant Treatment Hormone Receptor-Negative Breast Cancer Patients

Further study details as provided by Austrian Breast & Colorectal Cancer Study Group:

Primary Outcome Measures:

Overall survival
Recurrence-free survival

Secondary Outcome Measures:

Rate of breast-conserving procedures

Estimated Enrollment:	480
Study Start Date:	October 1991

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
1. hematopoiesis: > 3500/l leukocytes, > 100,000/l thrombocytes
2. renal function: creatinin < 1.5mg%
3. hepatic function: GOT  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:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309569

Sponsors and Collaborators

Austrian Breast & Colorectal Cancer Study Group

Investigators

Principal Investigator:

Raimund Jakesz, MD

Austrian Breast & Colorectal Cancer Study Group

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	ABCSG-7
Study First Received:	March 31, 2006
Last Updated:	March 31, 2006
ClinicalTrials.gov Identifier:	NCT00309569 History of Changes
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by Austrian Breast & Colorectal Cancer Study Group:

Cyclophosphamide
Methotrexate
Fluorouracil
Epirubicine
Breast Cancer

Study placed in the following topic categories:

Antimetabolites
Skin Diseases
Immunologic Factors
Adjuvants, Immunologic
Breast Neoplasms
Cyclophosphamide
Folic Acid Antagonists
Hormones

Immunosuppressive Agents
Folic Acid
Fluorouracil
Methotrexate
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents
Breast Diseases

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Cyclophosphamide
Reproductive Control Agents
Neoplasms by Site
Therapeutic Uses
Abortifacient Agents
Methotrexate
Alkylating Agents
Dermatologic Agents

Nucleic Acid Synthesis Inhibitors
Breast Diseases
Skin Diseases
Breast Neoplasms
Enzyme Inhibitors
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Fluorouracil
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 06, 2009