E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
carcinoma mammario con iperespressione di Her 2 o amplificazione dei geni codificanti per il recettore stesso. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10006187 |
E.1.2 | Term | Breast cancer |
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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 |
- Primary objective is to evaluate if 3 months (9 weekly administrations) of Herceptin (H) administered according to the Finnish protocol are not inferior to 12 months (18 three-weekly administrations) in a standard chemotherapy protocol in term of disease free survival, in patients with HER2 positive early breast cancer. |
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E.2.2 | Secondary objectives of the trial |
- Failure Rate (FR) at 2 yrs (relapse, contralateral breast tumor (excluding DCIS) , death for any cause, treatment discontinuation due to toxicity) - Cardiac events (absolute decrease of LVEF > 15%, absolute decrease of LVEF > 10% below 50%, CHF, other cardiac toxicities) |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patients are eligible if they meet the following criteria: - Surgically resected infiltrating primary breast cancer, HER2 positive tumor (either IHC 3+ or FISH+ according ASCO guidelines i.e. > 2.2; in case of polisomy, with > 6 gene copies ) , suitable for adjuvant chemotherapy -Adequate treatment of axillary lymphnodes (SNB or ALND) - Node positivity, or node negativity AND at least ONE of the following: T > 2 cm, Grade 3, presence of linfovascular invasion, Ki 67> 20%, age 35, hormone receptor negativity (<10%) - Age >18, 75 years - ECOG PS 0-1 - Normal liver, renal and marrow function, defined AS: leukocytes >3000/mcL, absolute neutrophil count >1,500/mcL, platelets >100,000/mcL, total bilirubin within normal Institutional limits, AST (SGOT)/ALT(SGPT) 2.5Xinstitutional upper limit of normal, Creatinine within normal institutional limits - Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or MUGA scan - Patients should start treatment within 10 weeks from the date of surgery - Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately, the patient should be apprised of the potential hazard to the fetus and potential risk for loss of the pregnancy - Ability to understand and the willingness to sign a written informed consent document |
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E.4 | Principal exclusion criteria |
Patients will be excluded from the study for any of the following reasons - Stage IIIB or IV breast cancer - More than 10 weeks from surgery (for patients undergoing re-excision of positive margins, or ALND following positive sentinel node biopsy, date of the last surgery will be taken into account) - Contraindication to the treatment with anthracycline, cyclophosphamide, 5FU, paclitaxel, or trastuzumab - Prior treatment with chemotherapy, endocrine therapy or radiotherapy. - Treatment with any other investigational agents - Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Pregnancy or breastfeeding (breast feeding should be discontinued to be enrolled in the study) - Women of childbearing potential that refusal to adopt adequate contraceptive measures |
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E.5 End points |
E.5.1 | Primary end point(s) |
primary end point is overall survival |
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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 | No |
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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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.8.5 | 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 | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |