FEC neo-adjuvant chemotherapy followed by weekly Taxol administration combined with Trastuzumab in II-III stage HER2 positive breast cancer patients.Fase II trial. - ND

• Conditions: II/III stage HER2+ eligible for neoadjuvant chemotherapy breast cancer women; MedDRA version: 9.1Level: LLTClassification code 10007308

• Registration Number: EUCTR2010-021600-24-IT
• Lead Sponsor: IST - ISTITUTO NAZIONALE PER LA RICERCA SUL CANCRO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-02
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

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

Inclusion Criteria

1)Female gender;2)Age = 18 years;3)ECOG Performance Status 0-1 (Appendix X);4)Histological diagnosis of infiltrating breast cancer:Primary tumor diameter = 2 cm clinically and by mammography or ultrasound or MNR measured candidate for neo-adjuvant chemotherapy-Any N-No evidence of metastasis(MO);5)HER2 overexpression and/or amplification in the invasive component of primary tumor under the following definitions:- 3+ overexpression by immunohistochemical (> 30% infiltrating tumor cells), - 2+ o 3+(in 30% or less of neoplastic cells) overexpression to immunoistochemical and gene amplification to FISH, - gene amplification to FISH( > 2.2 ratio; 6)Known hormon receptors status; 7)Hematopoietic status:absolute neutrophils number = 1.5 x 109/L,platelets = 100 x 109/L;8)Liver function:Total serum bilirubin = 1.5 x the institutional upper limit of normal (IULN) (< 2 IULN in case of Gilbert syndrome )- AST and ALT = 2.5 IULN, - alcalyne phosphatase = 2.5 IULN;9) Renal function: -creatinine = 2.0 mg/dL; 10)Cardiovascular: -baseline LVEF = 50% measure by echocardiography or MUGA scan; 11) Premenopausal patients:negative serum pregnancy test; 12)written informed consent
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

1)Male gender; 2)Histology other than adenocarcinoma; 3)Pregnant or lactating women; 4)Any prior treatment for invasive breast cancer; 5)History of uncontrolled or symptomatic angina pectoris,clinically relevant arrhythmias,congestive heart failure AMI,uncontrolled hypertension (= 180/110),unstable diabetes mellitus, dyspnea at rest, Chronic oxygen therapy 6)Uncontrolled active infetions; 7)Dementhia or any psycological or psychiatric condition that can affect the understanding and signing the Informed Consent ; 8)Concurrent neo-adjuvant therapy (chemotherapy, radiotherapy, hormonotherapy, biological therapies) 9) Any other neoplasm in the previouse 5 years except for in situ carcinoma of the cervix, basal and squamouse cell carcinoma of the skin not melanoma that have been curatively treated; 10)Any condition that makes inappropriate the patient`s participation in the study or any serious medical disorder that could affect the safety of the patient

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the rate of pathological complete response (pCR) to definitive surgery;Secondary Objective: - To evaluate the safety and tolerability of treatment especially in terms of cardiac toxicity. - To assess the rate of conversion to conservative surgery-To record DFS and OS;Primary end point(s): Pathological complete response (pCR):no evidence to surgery of invasive residual breast cancer both in breast and armpit area.Presence of carcinoma in situ only will be considered pathological complete response