Paclitaxel and Epirubicin as neoadjuvant systemic treatment for locally advanced breast cancer

Phase 2

Completed

• Conditions: Breast cancer; Cancer - Breast

• Registration Number: ACTRN12611000307909
• Lead Sponsor: The Queen Elizabeth Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Women aged 18 years or over with histological or cytologically confirmed locally advanced breast cancer. T3-4 Nx, Tx N2-3

Exclusion Criteria

Presence of metastatic disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rates- to be assessed clinically and radiologically ( CT scan) before surgery. Also pathological response rates to be assessed after surgery.[16 weeks]

Secondary Outcome Measures

Name	Time	Method
Tolerance- to be assessed by blood tests ( Hemogram. biochemistry) and clinical examination ( Physical examination/ radiology)[3 weeks - tolerance will be assesed before start of each course of chemotherapy. If the patient presents with symptoms before this then they will be assessed on presentation.];Disease free survival. This will be assessed by 3 monthly for the for the first 2 years and 6 monthly for the next 3 years. Tests will involve CT scan and blood tests at every visit and mammogram of the contralateral breast every 12 months.[3 months];Overall Survival<br>Follow up visits will be 3 monthly for the for the first 2 years and 6 monthly for the next 3 years. Death due to nay cause will be recorded and analysed for survival.[3 months]