Phase II Study of Neoadjuvant Epirubicin, Cyclophosphamide (EC) + Sorafenib Followed by Paclitaxel (P) + Sorafenib in Women With Previously Untreated

German Breast Group9 sites in 1 country36 target enrollmentNovember 2007

ConditionsBreast Cancer

InterventionsNexavar (Sorafenib)

DrugsNexavar (Sorafenib)

Overview

Phase: Phase 2
Intervention: Nexavar (Sorafenib)
Conditions: Breast Cancer
Sponsor: German Breast Group
Enrollment: 36
Locations: 9
Primary Endpoint: to establish the most feasible regimen of EC-P (P-EC) with sorafenib
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the efficacy and safety of sorafenib in the neoadjuvant setting in patients with primary breast cancer

Detailed Description

Epirubicin/Cyclophosphamide followed by Paclitaxel (EC/P) is a well tolerated regimen with high clinical activity. Histopathological complete remission after preoperative chemotherapy has a direct correlation with the disease-free and overall survival. The aim of combining a chemotherapy regime with sorafenib in the neoadjuvant setting is to increase the locoregional and systemic outcome of these patients

Registry

clinicaltrials.gov

Start Date

November 2007

End Date

December 2011

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

German Breast Group

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Unilateral or bilateral primary carcinoma of the breast,
•Tumor lesion in the breast with a palpable size of \>= 2 cm. The lesion has to be measurable in two-dimensions preferably by sonography. In case of inflammatory disease the extent of inflammation can be used as measurable lesion;
•Patients should have stages of disease in which adjuvant chemotherapy would be considered.
•Women of childbearing potential must have a negative serum pregnancy test
•Negative HER-2/neu status
•Karnofsky Performance status index \>= 80%;
•Normal cardiac function
•Laboratory requirements:
•Absolute neutrophile count (ANC) \>= 2,0 x 109/L and Platelets \>= 100 x 109/L and Hemoglobin \>= 10 g/dL (\>= 6.2 mmol/L) INR ≤ 1.5 ULN and PTT ≤ 1.5 ULN within 14 days prior to enrolment ASAT or ALAT \< 2.5 x ULN Alkaline phosphatase ≤ 5 UNL. Patients with ASAT and/or ALAT \> 1,5 x UNL associated with alkaline phosphatase \> 2,5 x UNL are not eligible for the study Total bilirubin \< 1 X UNL Creatinine ≤ 175 µmol/L (2 mg/dl). The calculated creatinine clearance should be ≥ 60 mL/min.
•Paraffin tumor tissue block and each one serum and one plasma sample centrally made available

Exclusion Criteria

•Patients with low or moderate risk, which are only doubtful candidates for adjuvant chemotherapy and do not fulfil the inclusion criteria No.
•Evidence of distant metastasis;
•Prior chemotherapy for any malignancy;
•Prior radiation therapy for breast cancer;
•Preexisting rhagades at hand and feet and other skin problems (e.g. psoriasis)
•Pregnant or lactating patients.
•Pre-existing motor or sensory neuropathy of a severity \>= grade 2 by NCI criteria;
•Concurrent treatment with: Chronic corticosteroids unless initiated \> 6 months prior to study entry and at low dose (\< 20 mg methylprednisolone or equivalent); Sex hormones. Prior treatment must be stopped before study entry; Patients with increased risk of bleeding due to concurrent therapeutic or prophylactic anticoagulative treatment. Low dose of coumarines are permitted.
•Other experimental drugs or any other anti-cancer therapy; Drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A within the last 5 days or their expected need
•Other serious illness or medical condition:

Arms & Interventions

Sorafenib

Single Arm: All patients receive sorafenib in addition to the established chemotherapy

Intervention: Nexavar (Sorafenib)

Outcomes

Primary Outcomes

to establish the most feasible regimen of EC-P (P-EC) with sorafenib

Time Frame: Time of surgery

Secondary Outcomes

Histopathological axillary nodal status after neoadjuvant therapy(Time of surgery)
Correlate baseline and change in tumor and serum genetic, gene expression and proteomic patterns with clinical and pathological response(Baeline till time of surgery)
pCR rate at surgery(Treatment ot Surgery)
Safety of preoperative regimen(Treatment to Surgery)
Determine clinical response rate(Time of surgery)