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

Phase 3

Completed

• Conditions: Early Stage Breast Cancer
• Interventions: Drug: Cyclophosphamide; Drug: Methotrexate; Drug: Fluorouracil; Drug: Epirubicin; Other: Surgery

• Registration Number: NCT00309569
• Lead Sponsor: Austrian Breast & Colorectal Cancer Study Group

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1991-10
• Primary Completion: 2000-09
• Study Completion: 2000-09
• Study First Submitted: 2006-03-31
• Study First Submitted QC: 2006-03-31
• Study First Posted: 2006-04-03
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-13
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 429

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A (pre- + postoperative chemotherapy)	Methotrexate	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.
A (pre- + postoperative chemotherapy)	Fluorouracil	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.
A (pre- + postoperative chemotherapy)	Epirubicin	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.
A (pre- + postoperative chemotherapy)	Surgery	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.
B (conventional postoperative chemotherapy)	Surgery	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.
A (pre- + postoperative chemotherapy)	Cyclophosphamide	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.
B (conventional postoperative chemotherapy)	Fluorouracil	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.
B (conventional postoperative chemotherapy)	Methotrexate	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.
B (conventional postoperative chemotherapy)	Cyclophosphamide	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.
B (conventional postoperative chemotherapy)	Epirubicin	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.

Primary Outcome Measures

Name	Time	Method
Overall survival
Recurrence-free survival

Secondary Outcome Measures

Name	Time	Method
Rate of breast-conserving procedures