PEGYLATED LIPOSOMAL DOXORUBICIN (CAELYX), CISPLATINUMAND FLUOROURACIL AS CONTINUOUS INFUSION (CCF) PLUSTRASTUZUMAB (HERCEPTIN) IN THE PREOPERATIVE TREATMENT OFLOCALLY ADVANCED BREAST CANCER - ND
- Conditions
- MedDRA version: 6.1Level: PTClassification code 10057654locally advanced breast cancer
- Registration Number
- EUCTR2006-006010-15-IT
- Lead Sponsor
- ISTITUTO EUROPEO DI ONCOLOGIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
? Patients with histologically proven locally advanced primary breast cancer (cT2-T3-T4 ad,
N0-3c, M0) or
Patients with histologically proven local recurrence after breast conserving surgery (rT1-
T4, N0-3c, M0) or
Patients with histologically proven local recurrence after mastectomy (M1 on the chest
wall) or
Patients with histological proven regional recurrence (axillary, suvraclavicular and internal
mammary chain lymph nodes)
? Patients with HER2 overexpression (+++)or with Her2/neu gene amplification
? Patients must be suitable for local treatment (radiotherapy and/or surgery) in a
multidisciplinary program
? Bilateral breast cancers are eligible
? Women aged 18?75 years
? ER PgR and c-erbB-2 expression defined according to EIO guidelines
? Performance status 0-2 (ECOG scale)
? Measurable and/or evaluable lesions
? No evidence of distant metastatic disease
? No clinically significant concomitant illness such as diabetes, cardiovascular, renal, or
neurological impairments
? LVEF >= 55% at basal echocardiography
? Absence of psychiatric illness undermining a correct understanding of the treatment
program
? WBC > 3,000/mm3; PLTS > 100,000/mm3
? AST, ALT, gamma-GT < 2.5 x upper normal limit and bilirubin < 1.5 mg/dl
? Serum creatinine in the normal range
? Institutional Signed Written Informed Consent obtained
? Pregnancy test (in fertile women). An effective contraceptive method must be prescribed
and its use verified for all women at potential risk of pregnancy
? Patients could have received prior anthracycline-including chemotherapy regimen for
breast cancer with a cumulative dose of doxorubicin<= 350 mg/m2 or epirubicin <= 720
mg/m2.
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
Absence of HER2/neu overexpression or amplification with FISH-test
? Patients with other non-malignant uncontrolled systemic diseases that would
preclude trial entry in the opinion of the investigator. Specifically not eligible are
patients with uncontrolled active infection, chronic infection such as active HBV or
HCV
? Patients with distant metastatic disease
? Clinical grade greater than or equal to 2 peripheral neuropathy.
? Previous adjuvant and/or neoadjuvant treatment with anthracyclines, cisplatin and/or
5-FU ended less than 12 months before study entry
? Previous adjuvant and/or neoadjuvant treatment with trastuzumab ended less than 6
months before study entry
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to estimate the antitumor activity of chemotherapy (CCF) plus<br><br>trastuzumab in terms of objective response in locally advanced breast cancer;Secondary Objective: 1. The rate of pathological complete remission<br><br>2. The disease free survival (DFS) and overall survival (OS)<br><br>3. The collection and storage of tumor tissue, plasma samples for future analysis of molecular<br><br>pathways and gene candidates.;Primary end point(s): rate of clinical response (partial and complete<br><br>remission)
- Secondary Outcome Measures
Name Time Method