EUCTR2014-000619-14-DE
Active, not recruiting
Phase 1
A randomized phase III trial comparing two dose-dense, dose-intensified approaches (ETC and PM(Cb)) for neoadjuvant treatment of patients with high-risk early breast cancer (GeparOcto) - GeparOcto
German Breast Group0 sitesJune 12, 2014
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- German Breast Group
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent according to local regulatory requirements prior to beginning specific protocol procedures.
- •Complete baseline documentation must be submitted via MEdCODES to GBG Forschungs GmbH.
- •Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy. Fine\-needle aspiration from the breast lesion alone is not sufficient. Incisional biopsy or axillary clearance 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 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.
- •Patients must have stage cT1c \- cT4a\-d disease. Patients with HER2\-positive or TNBC are eligible irrespective of nodal status (cN0\-cN3\). Patients with luminal B\-like tumors (defined here as ER and/or PgR \>1% stained cells, HER2 negative, Ki\-67 \>20%) only with histologically (sentinel\-node biopsy, core\- or fine\-needle biopsy) involved lymph nodes (pN1\-3\).
- •In patients with multifocal or multicentric breast cancer, the largest lesion should be measured.
- •Centrally confirmed ER, PR and HER2 status. Central pathology includes also assessment of Ki\-67 and LPBC status on core biopsy. ER/PR negative is defined as \<\=1% stained cells and HER2\-positive is defined as IHC 3\+ or in\-situ hybridization (ISH) and according to ASCO\-CAP guidelines as of 2013\). Formalin\-fixed, paraffin\-embedded (FFPE) breast tissue from core biopsy has therefore to be sent to the GBG central pathology laboratory prior to randomization.
- •Age ? 18 years.
- •Karnofsky Performance status index ? 90%.
- •Confirmed normal cardiac function by ECG and cardiac ultrasound (LVEF or shortening fraction) within 4 weeks prior to randomization. LVEF must be above 55%.
Exclusion Criteria
- •Patients with ER\- and/or PR\-positive, HER2\-negative breast cancer and Ki\-67 \<\= 20% (any luminal A\-like subtype) or luminal B\-like (Ki67\>20%) subtype without nodal involvement.
- •Patients with stages cT1a, cT1b, or any M1\.
- •Patients with pure lobular invasive breast cancer.
- •Prior chemotherapy for any malignancy.
- •Prior radiation therapy for breast cancer.
- •Pregnant or lactating patients. Patients of childbearing potential must agree to use one highly effective or two effective forms of non\-hormonal contraceptive measures during study treatment and 7 months following the last dose of mAbs.
- •Inadequate general condition (not fit for dose\-dense, dose\-intensified anthracycline\-taxane\-targeted agents\-based chemotherapy).
- •Previous malignant disease being disease\-free for less than 5 years (except CIS of the cervix and non\-melanomatous skin cancer).
- •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 \>140 / 90 mm Hg under treatment with two antihypertensive drugs), rhythm abnormalities requiring permanent treatment, clinically significant valvular heart disease.
- •History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent.
Outcomes
Primary Outcomes
Not specified
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