Phase II study of Paclitaxel and Epirubicin as Neoadjuvant Treatment for locally advanced Breast Cancer.

Phase 2

Active, not recruiting

• Conditions: Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12616000786493
• Lead Sponsor: The Queen Elizabeth Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1. Female aged 18 years or over with histological or cytologically confirmed locally advanced breast cancer. T3-4 Nx, Tx N2-3
2. No evidence of metastatic disease.
3. Normal cardiac function as determined by left ventricular injection fraction of greater that 50 % (gated heart pool scan or echocardiogram).
4. ECOG performance status of 0 or 1.
5. Must give written in form consent prior to commencement of any specific studies and any starting specific treatment.
6. Patients must be willing and able to comply with the protocol for the duration of the study.

Exclusion Criteria

1. Presence of metastatic disease.
2. Pregnant women or breast feeding mothers.
3. Women of child bearing potential who are unable or unwilling to use contraception.
4. Patients with a history of significant cardiac disease.
5. Patients with a history of significant neuropathy.
6. Patients with base line laboratory values with neutrophils less than 1.5 x 109/L, platelet count less than 100 x 109/L, serum creatinine greater than 1.5 x upper normal limit, serum bilirubin greater than 1.5 x upper normal limit, serum ALT or AST greater than 2.5 x upper normal limit, serum alkaline phosphatase greater than 2.5 x upper normal limit.
7. No patients with any prior malignancy other than completely excised basal cell carcinoma of the skin or completely resected cervical carcinoma in-situ.
8. Patients with any other uncontrolled medical condition or psychiatric condition deemed by the treating doctor to be unsuitable for treatment protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified