Phase II study of neoadjuvant epirubicin, cyclophosphamide (EC) + sorafenib followed by paclitaxel (P) + sorafenib in women with previously untreated primary breast cancer - Sofia

GBG Forschungs GmbH0 sites36 target enrollmentMarch 12, 2007

Overview

No summary available.

Registry

who.int

Start Date

March 12, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•\- Written informed consent for all study procedures including an additional core biopsy after the first 4 cycles of EC must be obtained and documented according to the local regulatory requirements;
•\- Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy. Fine\-needle aspiration is not sufficient. Incisional biopsy is not allowed. In case of bilateral cancer the investigator has to decide prospectively which side will be evaluated for the primary endpoint;
•\- 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. The following tumor stages are eligible:
•Locally advanced tumors with cT4 or cT3 or
•Tumors with cT2 cN\+
•In patients with multifocal or multicentric breast cancer, the largest lesion should be measured;
•\- Age \>\= 18 years
•\- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment;
•\- Negative HER\-2/neu status

•\- 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. Patients of childbearing potential must implement adequate non\-hormonal contraceptive measures (barrier methods, intra uterine contraceptive devices, sterilization) during study treatment;
•\- Pre\-existing motor or sensory neuropathy of a severity \>\= grade 2 by NCI criteria;
•\- 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 within past six months, evidence of transmural infarction on ECG, un\- or poorly controlled arterial hypertension (systolic blood pressure \>150 mm Hg or \> 90 mmHg diastolic blood pressure under treatment with two antihypertensive drugs), rhythm abnormalities requiring permanent treatment, clinically significant valvular heart disease
•Thrombotic or embolic events including transient ischemic attacks within the past six months