Trial Exploring Feasibility of Densification and Optimal Sequencing of Postoperative Adjuvant Fluorouracil, Epirubicin Plus Cyclophosphamide (FEC) and Docetaxel Chemotherapy in Patients With High Risk Primary Operable Breast Cancer

Study Description

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Brief Summary:

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. Several phase III and phase II clinical trials showed the benefits of dose-dense therapy (Q2W) over conventional treatment in breast cancer, lymphoma and SCLC. 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. The results of this randomized phase II study should serve as a basis for follow-up randomized phase III trial comparing conventional versus densified sequential FEC and docetaxel based regimens.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: dose dense with neulasta	Phase 2

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Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	117 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Randomized Phase II Trial Exploring Feasibility of Densification and Optimal Sequencing of Postoperative Adjuvant Fluorouracil, Epirubicin Plus Cyclophosphamide (FEC) and Docetaxel Chemotherapy in Patients With High Risk Primary Operable Breast Cancer
Study Start Date :	September 2005
Study Completion Date :	May 2006

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. 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 Outcome Measures :

1. To assess the safety and tolerability of FEC and docetaxel regimens including (febrile) neutropenia

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• 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 <70 years (upper age limit based on the lack of safety data for this population).
• Normal cardiac function (assessment of LVEF by MUGA scan or echocardiography above the lower limit of normal for the institution).
• Adequate organ function (as defined by neutrophils > 1.5 x109/L, Platelets > 100 x 109/L, Hemoglobin > 10 g/dl, total bilirubin > 1 UNL, ASAT (SGOT) and ALAT (SGPT) > 1.5 UNL, alkaline phosphatase > 2.5 UNL, creatinine > 1.5 mg/dl (150 µmol/L)
• Complete staging work-up within 2 months prior to registration. All patients will have bilateral mammography, chest X-ray (PA and lateral) and/or CT-scan, abdominal ultrasound and/or CT scan, bone scan. In case of positive bone scan suspicious for metastases, bone X-ray (or bone CT-scan on spinal hot spots) is mandatory to rule out the possibility of metastatic disease. Other tests may be performed as clinically indicated.
• Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential. Patients of childbearing potential must implement adequate non-hormonal measures to avoid pregnancy during study treatment (chemotherapy, radiotherapy and endocrine therapy). No pregnant or lactating patients are allowed.
• Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
• Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.

Exclusion criteria:

• Metastatic 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 infarction 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

Contacts and Locations

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Locations

Belgium
UZ Gasthuisberg Leuven
Leuven, Belgium, B-3000

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven

St-Augustinus Wilrijk

Investigators

Principal Investigator:	Hans Wildiers, MD, PhD	UZ Gasthuisberg Leuven

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	prof. dr. Hans Wildiers, adjunct head of clinic, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:	NCT00256360 History of Changes
Other Study ID Numbers:	2005-001876-11
First Posted:	November 21, 2005
Last Update Posted:	December 9, 2014
Last Verified:	December 2014

Keywords provided by prof. dr. Hans Wildiers, Universitaire Ziekenhuizen Leuven:

breast cancer; adjuvant; dose dense; docetaxel; pegfilgrastim

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Cyclophosphamide; Fluorouracil; Docetaxel; Epirubicin; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents, Alkylating	Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Myeloablative Agonists; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antimetabolites; Antimetabolites, Antineoplastic; Antibiotics, Antineoplastic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors