lymph node positive breast cancer patients MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Epirubicin
Product Code: E
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: EPIRUBICIN
CAS Number: 56420452
Current Sponsor code: E
Concentration unit: mg/
Sponsors
ABCSG (Austrian Breast & Colorectal Cancer Study Group)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1: Histological proven invasive primary breast cancer, with at least 5 (recommended 10) removed axillary lymph nodes OR negative sentinel node biopsy performed for the node negative cohort. 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) OR axillary node negative breast cancers if the primary tumour is larger than 20 mm and receptor negative (Er and Pgr with no receptor content) and being Elston grade III. 3: A primary breast cancer patient being 35 years or younger considered suitable for adjuvant chemotherapy (may be receptor negative or positive, HER-2/neu negative or positive, with or without axillary lymph node metastases) 4: Macroscopically and microscopically radical surgery, free margins (no cancer cells at borders of resection). 5: 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. 6: Female age 18-65. 7: Ambulant patients (ECOG 1 or less). 8: No major cardiovascular morbidity NYHA I or II. (Appendix 3). 9: Written informed consent according to the local ethics committee requirements. 10: 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 2000 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1: previous neo-adjuvant treatment. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: compare breast cancer relapse-free survival (BCRFS) (local-, regional-, distant breast cancer relapse or death due to breast cancer) in the tailored therapy arm (dtEC x 4-dtT x 4, A-arm) compared with the fixed dosed arm (FEC x 3-T x 3, B-arm).;Secondary Objective: Secondary objectives are to compare 1: Compare Distant disease-free survival (DDFS) 2: Compare Event-free survival 3: Overall survival (OS) 4: Health-related quality of life and toxicity analyses acc. to CTC 5: Outcome in relation to tumour biological factors and polymorphism patterns: a. RFS in relation to the Sorlie classes using immunohistochemical markers and/or gene expression profiling comparing A vs B arm b. RFS with receptor positive disease in the comparison between the A- and B-arms. c. RFS with high and low proliferation, respectively, in the comparison between the A- and B-arms. d. RFS in relation to HER-2/neu status in the primary cancers in the comparison between the A- and B-arms and analyzed whether trastuzumab was given in sequence or concurrently. e. RFS analyzed in relation to other molecular markers to outcome per arm f. RFS analyzed in relation to tumour associated lymphocytes and Y-box binding protein in the comparison between the A- and B-arms ;Primary end point(s): The primary endpoint is breast cancer recurrence-free survival (BCRFS) defined as time from randomization to the first of the events; local-, regional-, distant breast cancer recurrence or death due to breast cancer or last date of follow-up if no event has occured.;Timepoint(s) of evaluation of this end point: first occured event; local-, regional- or distant breast cancer recurrence or death due to breast cancer or last date of follow-up if no event has occurred | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - DDFS (Distant disease free survival) - EFS (event free survival) - OS (overall survival) - Health related Quality of Life - Outcome in relation to tumour biological factors and polymorphism patterns;Timepoint(s) of evaluation of this end point: -DDFS: first occurence of distant metastasis or death due to breast cancer -EFS: first occurence of events breast cancer recurrence (any type), contra-lateral breast cancer, other malignancy or any cause of death - OS: first occurence of any death | — |
Countries
Austria, Finland, Germany
Contacts
Public ContactTrial Office
ABCSG
Outcome results
None listed