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

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

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

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

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

- 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

- 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.

Exclusion Criteria:

- Patients with low or moderate risk, which are only doubtful candidates for adjuvant
chemotherapy and do not fulfil the inclusion criteria No. 5.

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Time of surgery

Safety Issue:


Principal Investigator

Sibylle Loibl, MD

Investigator Role:

Study Chair

Investigator Affiliation:

GBG Forschungs GmbH


Germany: Federal Institute for Drugs and Medical Devices

Study ID:

GBG 45



Start Date:

November 2007

Completion Date:

December 2011

Related Keywords:

  • Breast Cancer
  • Neoadjuvant chemotherapy
  • Targeted therapy
  • Breast Neoplasms