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

NCT00309569 | Completed Phase 3

• 1 other identifier: ABCSG-7
• Study Type: interventional
• Target: 429
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Early Stage Breast Cancer

Keywords

Cyclophosphamide; Methotrexate; Fluorouracil; Epirubicine; Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Overall survival

• Recurrence-free survival

Secondary Outcomes (1)

• Rate of breast-conserving procedures

Study Arms (2)

A (pre- + postoperative chemotherapy)

EXPERIMENTAL

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.

Drug: Cyclophosphamide; Drug: Methotrexate; Drug: Fluorouracil; Drug: Epirubicin; Other: Surgery

B (conventional postoperative chemotherapy)

EXPERIMENTAL

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.

Drug: Cyclophosphamide; Drug: Methotrexate; Drug: Fluorouracil; Drug: Epirubicin; Other: Surgery

Interventions

Cyclophosphamide DRUG

Cyclophosphamide 600mg/m2

A (pre- + postoperative chemotherapy); B (conventional postoperative chemotherapy)

Methotrexate DRUG

Methotrexate 40mg/m2

A (pre- + postoperative chemotherapy); B (conventional postoperative chemotherapy)

Fluorouracil DRUG

Fluorouracil 600mg/m2

A (pre- + postoperative chemotherapy); B (conventional postoperative chemotherapy)

Epirubicin DRUG

Epirubucin 60mg/m2 (only node-positive patients)

A (pre- + postoperative chemotherapy); B (conventional postoperative chemotherapy)

Surgery OTHER

Surgery

A (pre- + postoperative chemotherapy); B (conventional postoperative chemotherapy)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with bioptically verified breast cancer
• Estrogen receptor-negative status
• Age: \< 70 years
• WHO Performance Status \< 2
• Laboratory parameters
• hematopoiesis: \> 3500/mm3 leukocytes, \> 100,000/mm3 thrombocytes
• renal function: creatinin \< 1.5mg%
• hepatic function: GOT max. 2.5 x UNL
• bilirubin: \< 2.0 mg %
• metabolic parameters: Na, Ca, K in normal range
• \</= 4 weeks interval since surgery
• Informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Austrian Breast & Colorectal Cancer Study Group: lead

Related Links

• Related Info

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cyclophosphamide; Methotrexate; Fluorouracil; Epirubicin; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Raimund Jakesz, MD

  Austrian Breast & Colorectal Cancer Study Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2006
• First Posted: April 3, 2006
• Study Start: October 1, 1991
• Primary Completion: September 1, 2000
• Study Completion: September 1, 2000
• Last Updated: October 14, 2020

Record last verified: 2020-10