EUCTR2006-005834-19-DE
Active, not recruiting
Not Applicable
A phase III trials program exploring the integration of Bevacizumab, Everolimus (RAD001), and Lapatinib into current neoadjuvant chemotherapy regimes for primary breast cancer - GeparQuinto
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GBG Forschungs GmbH
- Enrollment
- 2727
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Written informed consent for all study procedures including an additional core biopsy after the first four cycles of EC \+/\-B must be obtained and documented according to local regulatory requirements prior to beginning specific protocol procedures.
- •2\. Patient has consented to the biomaterial collection and the paraffin\-embedded tumor tissue block of diagnostic core has been sent to central biomaterial banks.
- •3\. Complete baseline documentation must be sent to GBG Forschungs GmbH.
- •4\. 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.
- •5\. Tumor lesion in the breast with a palpable size of ? 2 cm or a sonographical size of ? 1 cm in maximum diameter. 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.
- •6\. Patients should be in a stage of disease in which adjuvant chemotherapy would be considered. Therefore the following tumor stages are eligible \*:
- •\- locally advanced tumors with cT3 or cT4 or
- •\- Estrogen (ER) and progesterone (PgR) receptor negative tumors or
- •\- ER or PgR positive tumors which are cN\+ (for cT2\) or pNSLN\+ (for cT1\).
- •\* During the Run\-In Phase only patients with cT4 or cT3 cN\+ disease are eligible.
Exclusion Criteria
- •1\. Patients with low or moderate risk, who are only doubtful candidates for adjuvant chemotherapy and do not fulfil the inclusion criterion No. 5\.
- •2\. Evidence of distant metastasis.
- •3\. Prior chemotherapy for any malignancy.
- •4\. Prior radiation therapy for breast cancer.
- •5\. Pregnant or lactating patients. Patients of childbearing potential must implement adequate non\-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization) during study treatment.
- •6\. Inadequate general condition (not fit for anthracycline\-taxane based chemotherapy).
- •7\. Previous malignant disease without being disease\-free for less than 5 years (except CIS of the cervix and non\-melanomatous skin cancer).
- •8\. Known or suspected congestive heart failure (\>NYHA I) and / or coronary heart disease, angina pectoris requiring antianginal medication, previous history of myocardial infarction, evidence of transmural infarction on ECG, uncontrolled or poorly controlled arterial hypertension (i.e. BP \>160 / 90 mm Hg under treatment with two antihypertensive drugs), rhythm abnormalities requiring permanent treatment, clinically significant valvular heart disease.
- •9\. Previous thromboembolic event (except pregnancy\-related thromboembolic events without genetic disposition).
- •10\. Known hemorrhagic diathesis or coagulopathy with increased bleeding risk.
Outcomes
Primary Outcomes
Not specified
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