This is a Neoadjuvant Study of AC Followed by Ixabepilone or Paclitaxel in Early Stage Breast Cancer That is HER-2 Negative and Estrogen Receptors Negative

Phase 2

Completed

• Registration Number: CTRI/2011/091/000021
• Lead Sponsor: The pharmaceutical company sponsoring this study is Bristol-Myers Squibb

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

Eligible women must have adenocarcinoma of breast that is ≥2 cm, T2-3, N0-3 and M0
�� Histologically confirmed primary invasive adenocarcinoma of the breast
�� Breast cancer must be ER and HER-2/neu negative
�� No prior treatment for breast cancer excluding therapy for DCIS
�� Karnofsky performance status of 80-100 LVEF ≥50% by echocardiogram or MUGA
�� Adequate hematologic, hepatic and renal function

Exclusion Criteria

WOCBP unwilling or unable to use an acceptable method to avoid pregnancy during and up to 8 weeks after the last dose of the investigational drug
�� Women who are pregnant or breastfeeding
�� Inflammatory or metastatic breast cancer
�� Unfit for breast and/or axillary surgery
�� Evidence of baseline sensory or motor neuropathy
�� Significant history of cardiovascular disease, serious intercurrent illness or infections
including known HIV infection
�� History of prior anthracycline therapy
�� Allergies to any study medication or Cremophor® E

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimate the pathologic complete response (pCR) rate in the two arms [Time Frame: at study completion]<br>&amp;#56256;&amp;#56442; Estimate pCR rate in a biomarker predefined population [Time Frame: at study completion]Timepoint: ;To Estimate the pathologic complete response (pCR) rate in the two arms [Time Frame: at study completion] &amp;#56256;&amp;#56442; Estimate pCR rate in a biomarker predefined population [Time Frame: at study completion]Timepoint: pathologic complete response (pCR) rate in the two arms [Time Frame: at study completion] &amp;#56256;&amp;#56442; Estimate pCR rate in a biomarker predefined population [Time Frame: at study completion]