Panther: A Study Comparing Biweekly and Tailored EC-T Versus Three Weekly FEC-T in Breast Cancer Patients

Exclusion Criteria

• •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).
• •Macroscopically and microscopically free margins after radical surgery (no cancer cells at borders of resection).
• •No proven distant metastases (negative chest/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.
• •Female age 18-65.
• •Ambulant patients (ECOG 1 or less).
• •No major cardiovascular morbidity NYHA I or II. (Appendix 3).
• •Written informed consent according to the local ethics committee requirements.
• •Patients of childbearing potential should have a negative pregnancy test within seven days of registration. (In Austria, pregnancy tests have to be repeated monthly during the treatment phase).
• •Previous neo-adjuvant treatment.
• •Non-radical surgery (histopathological positive margins).
• •Proven distant metastases.
• •Pregnancy or lactation.
• •Other serious medical condition.
• •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 (invasive and/or ductal carcinoma in situ) in the other breast without loco-regional (large lung volumes) radiotherapy, without objective findings for relapse, with \> 5 years since diagnosis can be included.
• •Abnormal laboratory values precluding the possibility to safely deliver the used cytotoxic agents in the study.
• •Hypersensitivity to drugs formulated in polysorbate 80.
• •Peripheral neuropathy grade ≥2.