PHASE II STUDY OF LIPOSOME-ENCAPSULATED DOXORUBICIN PLUS PACLITAXEL AND TRASTUZUMAB AS PRIMARY SYSTEMIC THERAPY FOR OPERABLE AND LOCALLY-ADVANCED BREAST CANCER - PACLIDOX 07

• Conditions: Operable breast cancer patients (T>2 cm, cT2-3, N0-N2, M0) or potentially operable, locally advanced breast cancer patients (T4, N0-2, M0) or inflammatory breast cancer patients (T4d, N0-2, M0), with or without HER2 overexpression or amplification; MedDRA version: 9.1Level: HLTClassification code 10006290Term: Breast and nipple neoplasms malignant

• Registration Number: EUCTR2008-001369-27-IT
• Lead Sponsor: AZIENDA OSPEDALIERA OSPEDALE S. SALVATORE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-26
• Last Update Posted: 17 March 2014

Recruitment & Eligibility

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

Inclusion Criteria

- Histologically confirmed breast cancer. - Operable breast cancer patients (T>2 cm, cT2-3, N0-N2, M0) or potentially operable, locally advanced breast cancer patients (T4, N0-2, M0) or inflammatory breast cancer patients (T4d, N0-2, M0), with or without HER2 overexpression or amplificationu` - Hercept-test (DAKO) or FISH performed - Age > 18 and < 75 - ECOG performance status 0-1 - Life expectancy >3 months.
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

- Prior chemotherapy. - History of prior malignancy in the last 10 years (other than non-melanoma skin cancer or excised cervical carcinoma in situ). - Other serious illness or medical condition - Congestive hearth failure or angina pectoris even if it is medically controlled. Previous history of myocardial infarction, uncontrolled high risk hypertension or arrhythmia - Pregnant and lactating women

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: - To evaluate the pathological complete response (pCR) rate (A pathological complete response will be defined as disappearance of tumor cells in breast and axillary lymph-nodes by pathological examination);Secondary Objective: - To evaluate the clinical response rate (RR). - To determine the feasibility and systemic tolerability. - To assess the rate of successful breast-conservation surgery;Primary end point(s): - To evaluate the pathological complete response (pCR) rate (A pathological complete response will be defined as disappearance of tumor cells in breast and axillary lymph-nodes by pathological examination)