SHORT-HER: MULTICENTRIC RANDOMISED PHASE III TRIAL OF ADJUVANT CHEMOTHERAPY PLUS 3 VS 12 MONTHS OF TRASTUZUMAB IN BREAST CANCER PATIENTS WITH HER2 POSITIVE DISEASE - shorther

• Conditions: carcinoma mammario con iperespressione di Her 2 o amplificazione dei geni codificanti per il recettore stesso.; MedDRA version: 9.1Level: LLTClassification code 10006187Term: Breast cancer

• Registration Number: EUCTR2007-004326-25-IT
• Lead Sponsor: AZIENDA OSPEDALIERA POLICLINICO DI MODENA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - 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.;Secondary Objective: - 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);Primary end point(s): primary end point is overall survival