E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Eligible will be only females between 18 - 70 years of age, suffering from histologically confirmed primary breast cancer, nodal status positive or negative, phase cT2, cT3, or cT4 including inflammatory disease. Metastatic disease is excluded. All patients will be treated with 3 cycles Docetaxel and 3 cycles FEC. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006201 |
E.1.2 | Term | Breast cancer stage III |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021974 |
E.1.2 | Term | Inflammatory breast cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006202 |
E.1.2 | Term | Breast cancer stage IV |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006200 |
E.1.2 | Term | Breast cancer stage II |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
identification and validation of a predictive gene expression profile for pCR to treatment with 3 x docetaxel followed by 3 x FEC (q3w) in patients with breast cancer |
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E.2.2 | Secondary objectives of the trial |
- identification and validation of a predictive gene expression profile for cCR to treatment with docetaxel - FEC - validation of in-vitro generated gene expression signatures for docetaxel as well as FEC - estimation of the tumor response rate (clinical and pathological confirmed complete response, pCR) - ratio of breast-preserving surgeries after chemotherapy |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- histologically confirmed breast carcinoma (including determination of estrogen and progesteron receptor status, grading, her-2/neu-state) - phase cT2, cT3, or cT4 including inflammatory breast carcinoma - nodal negative or positive patients - no evidence for distant metastasis after complete staging including chest X-ray, abdominal sonography, and bone scan within 4 weeks prior to randomisation - no prior surgical, cytostatical, or hormonal therapy (excluding hormonal substitution or contraception), no prior radiation or immunotherapy - primary tumor which is clinical and/or measurable in 2 dimensions by an imaging analysis (obligatory is bilateral mamogram and breast sonography, fakultativ is MRI) - adequate reserve of bone marrow: neutrophils ≥ 1.5 x 10*9/L, platelets ≥ 100 x 10*9/L, hemoglobin ≥ 100 g/L - adequate hepatic and renal function; ASAT (SGOT) and ALAT (SGPT) < 2,5 x ULN, bilirubin and creatinine in normal range (if creatinine is out of normal range creatinine clearance has to be > 60 ml/minute) - normal cardiologic state according to age, estimated by ECG and echocardiography within 4 weeks before start of treatment - ECOG performance state 0-2 - age 18 to 70 years - negative pregnancy test (urine or serum) within 7 days prior to registration for woman of childbearing potential - patients have to be available for treatment and follow up examinations. Treatment of a patient who has been randomised to study has to take place at a participating site (site of PI or sub-investigator). The participating site is also incumbent on documentation of follow up examinations. - signed, written informed consent (approved by the Ethics Committee) obtained prior to registration - including patient´s adopted acceptance of therapy and follow up visits - signed, written informed consent of patient for gene expression analysis and the related examinations |
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E.4 | Principal exclusion criteria |
- pregnant or lactating woman; patients with childbearing potential have to use an effective mechanic form of contraception - current motoric or sensoric neuropathy ≥ grade 2 (according to NCI criteria) - pre-existing cardiac diseases which do not admit participating on the study (f. e. LVEF < 50% or unstable Angina Pectoris, history of myocard infarction within one year of randomisation, uncontrolled hypertension > 165/90 mm Hg, high risk, uncontrolled arrhytmia) - history of significant neurological or psychiatric disease (including psychotic disease, dementia and attacks), which could affect understanding of study or agreement on study. - current uncontrolled infection - current gastric ulcer, unstable diabetes mellitus - history of other malignancy except for carcinoma in situ of the cervix or basal cell carcinoma or an other tumor with a disease-free interval of > 12 months after treatment - current daily chronic treatment with corticosteroids (dose of > 20 mg methylprednisolone equivalent), which started within 6 months prior to randomisation - contraindication to treatment with corticosteroids - current treatment with other experimental medication or participation on an other clinical trial with investigative substances within 30 days prior to registration - any other current anticancer therapy - current therapy with sex hormones (treatment has to be discontinued before registration) - male patient
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint is the identification and validation of a predictive gene expression signature for pCR to therapy with docetaxel-FEC.
Secondary endpoints are - identification and validation of a predictive gene expression profile for cCR to treatment with docetaxel - FEC - validation of in-vitro generatied gene expression signatures for docetaxel as well as FEC - estimation of the tumor response rate (clinical and pathological confirmed complete response, pCR) - ratio of breast-preserving surgeries after chemotherapy |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Surgery of last patient treated during the course of study |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |