Reinduction with liposomal anthracyclines and Capecitabine in patients with breast cancer, locally advanced (IIIA-IIIB-IIIC) HER2 negative, not obtaining a pathological complete response (<PCR) after primary chemotherapy. - ICARO 2

• Conditions: Population of female patients suffering from breast cancer in initial clinical stage IIIA, IIIB and IIIC not expressing HER2 and who have not obtained a pathological complete response (defined <PCR) after neoadjuvant chemotherapy; MedDRA version: 12.0Level: LLTClassification code 10006283Term: Breast neoplasm malignant female

• Registration Number: EUCTR2009-011756-22-IT
• Lead Sponsor: AZIENDA OSPEDALIERO UNIVERSITARIA DI CAGLIARI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-18
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

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

Inclusion Criteria

Patient with residual disease on breast and / or axillary lymph nodes (- Initial histologic diagnosis with pathological characterization of: Grading, RE / PGR, Ki67, p53
- Initial Stage IIIA, IIIB, IIIC
- State hormone receptor positive or negative
- State-negative HER2 achieved with immunohistochemical methods or in situ hybridization using fluorescence (FISH)
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

History of cancer in the previous 10 years (except skin cancer non-melanoma or cervical carcinoma in situ radically excised).
- More serious illnesses.
- Chronic renal failure
- Congestive heart failure or angina pectoris even if controlled. Previous history of myocardial infarction, uncontrolled hypertension, or arrhythmia.
- History of psychiatric or neurological disorders including dementia and epilepsy.
- Infection in place.
- Treatment with other experimental drugs.
- Geographical inaccessibility to treatment and follow up.
- Pregnancy or lactation

Study & Design

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