Epirubicine plus Cyclophosphamid followed by Docetaxel +/- Sunitinib before surgery for the treatment of patients with HER2neu-negative operable breast cancer

• Conditions: HER2neu-negative operable breast cancer

• Registration Number: EUCTR2009-009874-28-AT
• Lead Sponsor: ABCSG - Austrian Breast & Colorectal Cancer Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

- Patients with histologically or cytologically diagnosed HER2neu-negative (FISH negative or IHC 0 or +1) invasive cancer of the breast scheduled to receive chemotherapy (FEC/EC, Docetaxel)
- Stage I, II or Stage III (T1-4a-c, N0-N3 and M0)
- No prior chemotherapy, radiotherapy, or endocrine therapy for invasive or noninvasive breast cancer
- 18 years of age or older
- ECOG performance status 0, 1
- Adequate organ function as defined
- Signed and dated informed consent
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Metastatic disease
- Her-2/neu overexpressing breast cancer
- Lobular breast cancer except triple-negative tumors
- Inflammatory carcinoma (T4d)
- Prior treatment for breast cancer or current treatment with another antitumor therapy
- Other malignancy within the last 5 years before randomization except for curatively treated non melanoma skin cancer and in situ carcinoma of the cervix
- Patients for whom Docetaxel is contraindicated according to the local prescribing information
- Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular incident including transient ischemic attack, or pulmonary embolus.
- Ongoing cardiac dysrhythmias of grade >2, atrial fibrillation of any grade, or QTc interval >470 msec.
- Hypertension that cannot be controlled by medication (>150/100 mm Hg despite optimal medical therapy).
- Current treatment with therapeutic doses of Phenprocoumon (low dose Phenprocoumon up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
- Concomitant use of drugs with dysrhythmic potential
- Pre-treatment with Sunitinib
- Concurrent participation in another clinical trial evaluating the same end point
- Known human immunodeficiency virus infection.
- Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to study entry. In addition pregnancy tests must be performed at least monthly during therapy and at the end of the therapy in pre-menopausal patients. In post-menopausal patients see protocol section 7.1 Screening.
- Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the study is to assess a neoadjuvant sequential chemotherapy containing of FEC or EC followed by Docetaxel in combination with Sunitinib in comparison to the same neoadjuvant sequential chemotherapy containing of FEC or EC followed by Docetaxel in combination with Placebo concerning complete pathological response rate (pCR) in patients with HER2neu-negative operable invasive breast cancer.;Secondary Objective: Assessment of radiological response rate, breast-conservative surgery rate, reduction of tumor size, tolerability, safety.;Primary end point(s): The aim of the study is to assess a neoadjuvant sequential chemotherapy containing of FEC or EC followed by Docetaxel in combination with Sunitinib in comparison to the same neoadjuvant sequential chemotherapy containing of FEC or EC followed by Docetaxel in combination with Placebo concerning complete pathological response rate (pCR) in patients with HER2neu-negative operable invasive breast cancer.