The rationale of this randomized phase II study is to investigate the feasibility of sequenced densified FEC and docetaxel based regimens in patients with primary operable high-risk breast cancer. The aim of the study is also to demonstrate that further shortening of treatment interval from 14 days to 10-11 days in FEC regimen is feasible and will not compromise patient’s safety.
Conditions
Interventions
Trade Name: taxotere
Product Name: taxotere
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Docetaxel
Other descriptive name: 20 mg vial
Concentration unit: mg m
Sponsors
UZLeuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria in order to be eligible for participation in this study: • Histologically proven early breast cancer requiring adjuvant chemotherapy (lymph node positive or other features of high risk according to St-Gallen criteria) • Margins of resection histologically free of invasive carcinoma and ductal carcinoma in situ. • Radiotherapy performed according to center’s policy and always follows completion of adjuvant chemotherapy • Performance status 0 to 1 on the ECOG scale (Appendix A) • The determination of ER and PgR is mandatory (immunohistochemical methods required; ER and/or PgR positivity is defined as > 1% of positive cells). Also determination of Her2neu is mandatory, either by immunohistochemistry or by FISH • Age ? 18 years and age =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 4.2 Exclusion criteria • metastasic disease (M1) or inoperable residual axillary disease • prior systemic anticancer therapy for breast cancer (chemotherapy, hormone therapy of immunotherapy) • prior radiation therapy for breast cancer. • pre-existing motor or sensory neurotoxicity of a severity ? grade 2 by NCI criteria. • Pregnant or lactating patients • Other serious illness or medical condition: • Congestive heart failure or unstable angina pectoris, previous history of myocardial infaction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias. • History of significant neurological or psychiatric disorders that would prohibit the understanding and giving of informed consent. • Active uncontrolled infection • Active peptic ulcer, unstable diabetes mellitus. • Past or current history of other neoplasm except for curatively treated basal cell skin cancer or in situ carcinoma of the cervix. • Chronic treatment with steroids unless initiated > 6 months prior to study entry and at low dose (? 20 mg methylprednisolone or equivalent) • Concurrent treatment with hormonal replacement therapy: this treatment should be stopped at least 15 days before study entry. • Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry. • Concurrent treatment with any other anti-cancer therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the feasibility of FEC and docetaxel based sequential regimens given in dose-dense fashion (FEC every 10-11 days and docetaxel every 14 days) with pegfilgrastim in patients with high-risk primary breast cancer. ;Secondary Objective: To assess the safety and tolerability of FEC and docetaxel regimens including (febrile) neutropenia;Primary end point(s): The primary endpoint of this randomized phase II study is the number of patients in each arm who complete all intended cycles at an overall relative dose intensity of at least 85% of the global regimen. | — |
Countries
Belgium
Outcome results
None listed