Neoadjuvant Chemotherapy Including Sorafenib in Women With Previously Untreated Primary Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Application Of Epirubicin Within A Neo-/Adjuvant Chemotherapy In Patients With Primary Breast Cancer

NCT01061359

Breast Neoplasm

COMPLETED

Study Adding Multikinase Inhibitor Sorafenib to Existing Endocrine Therapy in Patients With Advanced Breast Cancer

NCT00525161

Breast Cancer

TERMINATED PHASE2

Neoadjuvant Chemotherapy of Primary Breast Cancer With Epirubicin/Docetaxel and Carboplatin/Docetaxel

NCT00527449

Primary Breast Cancer

COMPLETED PHASE2

BAY43-9006 - Phase II in Advanced Breast Cancer

NCT00101400

Breast Neoplasms Breast Cancer

COMPLETED PHASE2

Primary Chemotherapy With Docetaxel-Capecitabine and Doxorubicin-Cyclophosphamide in Breast Cancer

NCT00005908

Breast Cancer Breast Neoplasm

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sorafenib

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

Group Type OTHER

Nexavar (Sorafenib)

Intervention Type DRUG

Tablet, Sorafenib follows a patient specific escalation scheme starting with 200 mg daily up to a maximum dose of 800 mg daily during EC chemotherapy on day 2-19. The achieved dose will be continued during paclitaxel chemotherapy during week 1-11 all day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nexavar (Sorafenib)

Tablet, Sorafenib follows a patient specific escalation scheme starting with 200 mg daily up to a maximum dose of 800 mg daily during EC chemotherapy on day 2-19. The achieved dose will be continued during paclitaxel chemotherapy during week 1-11 all day

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* Complete staging work-up within 3 months prior to registration.
* Patients must be available and compliant for treatment and follow-up. Patients registered on this trial must be treated and followed up at the participating or a cooperating center.

* 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; 7. 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 8. Other serious illness or medical condition:

* Previous malignant disease without being disease-free of less than 5 years (except CIS of the Cervix and non-melanomatous skin cancer)
* Known or suspected congestive heart failure (≥NYHA II) and/or coronary heart disease, angina pectoris requiring antianginal medication, previous history of myocardial infarction, evidence of transmural infarction on ECG, un- or poorly controlled arterial hypertension, rhythm abnormalities requiring permanent treatment, clinically significant valvular heart disease
* Thrombotic or embolic events
* Hemorrhage/bleeding event ≥ Grade 3 within 4 weeks prior study entry
* Evidence or history of bleeding diathesis or coagulopathy
* History of significant neurological or psychiatric disorders
* Patients with seizure disorders requiring medication such as steroids or antiepileptics
* Currently active infection
* History of HIV infection or chronic hepatitis B or C
* Serious non healing wound, ulcer or bone fracture
* Patients with prior immunosuppressive treatment
* Severe pulmonary condition/illness
* Disease significantly affecting gastrointestinal function,
* Patients with severe liver disease
* Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug
* Definite contraindications for the use of corticosteroids
* Inadequate general condition (not fit for anthracycline/taxane-containing chemotherapy)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No