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NCT00309569 Clinical Trial

Randomized Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment in Receptor-negative Patients

Early Stage Breast Cancer Clinical Trial

Official title:
A Randomized Phase III Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment Hormone Receptor-negative Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00309569
Other study ID # ABCSG-7
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 1991
Est. completion date September 2000

Study information
Verified date October 2020
Source Austrian Breast & Colorectal Cancer Study Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 429
Est. completion date September 2000
Est. primary completion date September 2000
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients with bioptically verified breast cancer

- 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:

- 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Cyclophosphamide
Cyclophosphamide 600mg/m2
• Methotrexate
Methotrexate 40mg/m2
• Fluorouracil
Fluorouracil 600mg/m2
• Epirubicin
Epirubucin 60mg/m2 (only node-positive patients)
Other:
• Surgery
Surgery

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Austrian Breast & Colorectal Cancer Study Group

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival
Primary Recurrence-free survival
Secondary Rate of breast-conserving procedures
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