Please refer to German text below
- Conditions
- Early primary breast cancer, hormone receptor positve or negative, HER2 negative, any nodal statusTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-003679-21-DE
- Lead Sponsor
- Westdeutsche Studiengruppe GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 80
1.Female patients, age at diagnosis 18 - 75 years
2.Histological confirmed unilateral primary invasive carcinoma of the breast
3.Clinical cT1 (> 1 cm) - cT4 (if operable, inflammatory breast cancer is excluded)
4.HER2 over-expressing tumor confirmed by: 3+ by Immunohisto-chemistry (IHC) and/or HER2/neu gene amplification by fluorescence, chromogenic or silver in-situ hybridization [FISH, CISH or SISH; >6 HER2 gene copies per nucleus or a FISH, CISH or SISH test ratio (HER2 gene copies to chromosome 17 signals) of = 2.0]
5.Clinically node positive disease or node negative disease
6.No clinical evidence for distant metastasis (cM0) after conventional staging
7.Performance Status ECOG = 1 or KI = 80%
8.Baseline LVEF > 50% measured by echocardiography
9.Negative pregnancy test (urine or serum) within 7 days prior to start of induction treatment in premenopausal patients
10.The patient must be accessible for treatment and follow-up
11.Written informed consent including a written informed consent for shipping of tumor block for central pathology review and evaluation prior to the start of any 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 64
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16
1.Known hypersensitivity reaction to the compounds or incorporated substances
2.Known polyneuropathy grade = 2
3.Severe and relevant comorbidity that would interact with the application of cytotoxic agents or the participation in the study including active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, stable chronic liver disease per investigator assessment).
4.Prior malignancy with a disease-free survival of < 10 years, except curatively treated basalioma of the skin, pTis of the cervix uteri
5.Prior or concurrent treatment with cytotoxic agents for any reason after consultation with the sponsor
6.Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry
7.Male breast cancer
8.Concurrent pregnancy; patients of childbearing potential must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment
9.Breast feeding women
10.Sequential breast cancer
11.Lack of patient compliance
12.Inadequate organ function including:
•Leucocytes < 3.5 x 109/l
•Platelets < 100 x 109/l
•Absolute Neutrophil Count (ANC) < 1.5 x 109/l
•Hemoglobin < 9 g/dl
•Serum Creatinine > 2.0 x ULN1.5 mg/dl
•Serum Bilirubin > 1.1 mg/dl
•Alkaline phosphatase > 2.5 x ULN
•ASAT and/or ALAT > 2.5 ULN
•Albumin < 2.5 g/dl
13.Uncompensated cardiac function
14.Malabsorption syndrome, disease significantly affecting gastrointestinal function
15.Concomitant use of CYP3A4 inhibitors or inducers
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary objective: To establish a dynamic test after three weeks of neo-adjuvant therapy, which discriminates between responders and non-responders at final surgery (defined as pathological complete response by no invasive patterns in the breast and lymph nodes);Secondary Objective: •Event free survival (EFS) and overall survival (OS)<br>•Toxicity<br>•Cost efficacy<br>;Primary end point(s): Primary endpoint: <br>•pathological complete response (pCR) at final surgery;Timepoint(s) of evaluation of this end point: Final surgery
- Secondary Outcome Measures
Name Time Method