Know Cancer

or
forgot password

A Randomized Phase II Biomarker Neoadjuvant Study of Sequential AC Followed by Ixabepilone Compared to Sequential AC Followed by Paclitaxel in Women With Early Stage Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Randomized Phase II Biomarker Neoadjuvant Study of Sequential AC Followed by Ixabepilone Compared to Sequential AC Followed by Paclitaxel in Women With Early Stage Breast Cancer

Inclusion Criteria


Inclusion criteria

- Histologically confirmed primary invasive adenocarcinoma of the breast , T2-3, N0-3,
M0, with tumor size of ≥ 2 cm

- All patients with early stage breast adenocarcinoma may enroll irrespective of
receptor status

- No prior treatment for breast cancer excluding therapy for DCIS

- Karnofsky performance status of 80 - 100

- left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram or multiple gated
acquisition (MUGA)

- Adequate hematologic, hepatic and renal function

Exclusion Criteria

- women of child-bearing potential (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 human immu immunodeficiency virus (HIV) infection

- History of prior anthracycline therapy Allergies to any study medication or
Cremophor® EL

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants Achieving Pathologic Complete Response (pCR)

Outcome Description:

The pCR was defined as no histologic evidence of residual invasive adenocarcinoma in the breast and axillary lymph nodes, with or without the presence of ductal carcinoma in situ (DCIS) in the breast.

Outcome Time Frame:

at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA163-100

NCT ID:

NCT00455533

Start Date:

October 2007

Completion Date:

December 2009

Related Keywords:

  • Breast Cancer
  • Early Breast Cancer
  • Breast Neoplasms

Name

Location

Virginia Mason Medical CenterSeattle, Washington  98111
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Comprehensive Cancer CenterGlendale, California  91204
Albert Einstein Cancer CenterBronx, New York  10461
Moffitt Cancer CenterTampa, Florida  33612
Florida Cancer Research InstituteDavie, Florida  
Northwest Oncology & Hematology AssociatesCoral Spring, Florida  33065
Medical Specialists Of Palm BeachesLake Worth, Florida  33467
University Medical Center, IncLouisville, Kentucky  40202
Providence Cancer CenterSpokane, Washington  99204