The SBG 2004-1/ABCSG 25 Study - a randomised phase III study: Comparing two weekly and tailored epirubicin + cyclophosphamide followed by two weekly tailored docetaxel (dtEC->dtT) (A-arm) versus three weekly epirubicin + cyclophosphamide, 5-fluorouracil followed by docetaxel (FEC->T) (B-arm) in lymph node positve breast cancer patients - a continuation of the feasibility part of the SBG 2004-1 - SÖS Study

• Conditions: lymph node positive breast cancer patients; MedDRA version: 9.1Level: LLTClassification code 10006187Term: Breast cancer

• Registration Number: EUCTR2007-002061-12-FI
• Lead Sponsor: ABCSG (Austrian Breast & Colorectal Cancer Study Group)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-23
• Last Update Posted: 5 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 900

Inclusion Criteria

1: Histological proven invasive primary breast cancer, with at least 5 (recommended 10) removed axillary lymph nodes. Interval between definitive surgery that includes axillary lymph node dissection and registration must be less than 60 days. Paraffin block from the primary tumour must be retained (not mandatory for Austrian sites).
Frozen tumour tissue is strongly recommended to be stored.
2: Receptor negative or positive tumours with 1 or more positive axillary lymph nodes (>0.2 mm).
3: Macroscopically and microscopically radical surgery, free margins (no cancer cells at borders of resection).
4: No proven distant metastases (negative pulmonary X-ray, bone scintigram (when clinical signs of skeletal metastases or elevated ALP) supplemented with normal conventional X-ray of hot spots, normal liver function test and haematological function tests; when abnormal values, CT or ultrasound of the liver, patient can be included if no metastases are demonstrated.
5: Female age 18-65.
6: Ambulant patients (ECOG 1 or less).
7: No major cardiovascular morbidity NYHA I or II. (Appendix 3).
8: Written informed consent according to the local ethics committee requirements.
9: Patients of childbearing potential should have a negative pregnancy test within seven days of registration.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1: Locally advanced breast cancer.
2: Non-radical surgery (histopathological positive margins).
3: Proven distant metastases.
4: Pregnancy or lactation.
5: Other serious medical condition.
6: Previous or concurrent malignancies at other sites, except basal cell carcinoma and/or squamous cell carcinoma in situ of the skin or cervix. Patients with previous breast cancer in the other breast without loco-regional (large lung volumes) radiotherapy, without objective findings for relapse, with > 5 years since diagnosis can be included.
7: Abnormal laboratory values precluding the possibility to safely deliver the used cytotoxic agents in the study.
8: Hypersensitivity to drugs formulated in polysorbate 80.
9: Peripheral neuropathy grade =2.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the phase III study is to compare breast cancer relapse-free survival (BCRFS) between the dtEC?dtT and FE100C?T. To detect a five-year BCRFS difference of 0.70 to 0.80 about 450 patients per arm will be needed. They will be recruited during three years and followed another two years for breast cancer events.;Secondary Objective: Secondary objectives are to compare <br>1:Distant disease-free survival (DDFS)<br>2:Event-free survival and <br>3:Overall survival<br>4:Health-related quality of life<br>5:Outcome in relation to tumour biological factors and polymorphism patterns<br>;Primary end point(s): Compare breast cancer recurrence-free survival (BCRFS) (local-, regional-, distant breast cancer relapse or death due to breast cancer), in the tailored therapy arm (dtEC?dtT, A-arm) compared with the fixed dosed arm (FEC?T x 3).