A Randomized Trial of Ixempra Versus Taxol in Adjuvant Therapy of Triple Negative Breast Cancer

Completed · Phase 3

Conditions studied: Breast Cancer

In brief

This is a randomized, Phase III, open-label, multicenter study.

Key facts

Study ID

NCT00789581

Run by

SCRI Development Innovations, LLC

People needed

614

Starts

2008-12-01

Expected to finish

2016-11-01

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female patients greater than or equal to18 years of age.
• Histologically confirmed invasive unilateral breast cancer (regardless of
• histology).
• Early-stage breast cancer, defined as:
• Node-positive disease: >0.2-mm metastasis in at least one lymph node (pN1mipN2b)OR
• Node-negative, with primary tumor >1.0 cm (T1c-T3).
• Definitive loco-regional surgery must have been completed as specified
• below:
• Patients must have undergone either breast conservation surgery
• (i.e., lumpectomy) or total mastectomy.
• Surgical margins of the resected section must be histologically free of
• invasive adenocarcinoma and ductal carcinoma in situ.
• Surgical margins involved with lobular carcinoma in situ (LCIS) will not
• be considered as a positive margin; therefore, such patients will be eligible for this study without additional resection.
• Patients must have completed axillary lymph node sampling for the pathologic evaluation of axillary lymph nodes as specified below:
• Sentinel node biopsy and/or either lymph node sampling procedure or axillary dissection.
• Multicentric and multifocal invasive breast cancer is eligible if loco-regional surgery has been completed as described above.
• Patients with synchronous bilateral cancers are eligible only if:
• All cancers are of triple-negative phenotype, defined as ER-, PR-, HER2-.
• Eligibility based on the highest stage grouping.
• HER2 negative tumors. HER2 negativity must be confirmed by one of the
• following:
• FISH-negative (FISH ratio <2.2), or
• IHC 0-1+, or
• IHC 2-3+ AND FISH-negative (FISH ratio <2.2).

You may not qualify if…

• Women who are pregnant or breastfeeding.
• History of previous diagnosis of invasive breast cancer (unless treated >5 years previously with no recurrence). History of previously treated ductal carcinoma in situ (DCIS) is acceptable.
• Any evidence or suspicion of metastatic disease other than ipsilateral
• axillary lymph nodes.
• Any tumor >=T4 (cutaneous invasion, deep adherence, inflammatory breast cancer).
• Previous anthracycline chemotherapy.
• Concurrent use of CYP3A4 inhibitors from 72 hours prior to initiation of
• study treatment until the end of treatment with ixabepilone.
• Previous treatment for this breast cancer (including neoadjuvant
• chemotherapy).
• Previous cancer (with the exception of non-melanoma skin cancer or cervical carcinoma in situ) in the past 5 years (including invasive contralateral breast cancer).
• Peripheral neuropathy of > grade 1 per NCI CTCAE v3.0.
• Cardiac disease, including: congestive heart failure (CHF) > Class II per
• New York Heart Association (NYHA) classification; unstable angina (anginal symptoms at rest) or new-onset angina (i.e., began within the last 3 months), or myocardial infarction within the past 6 months; symptomatic CHF, unstable angina pectoris, cardiac arrhythmia, or cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
• History of hypersensitivity to CremophorEL (polyoxyethylated castor oil) or
• a drug formulated in CremophorEL such as paclitaxel.
• Use of any investigational agent within 30 days of administration of the first dose of study drug.
• Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
• Concurrent severe, uncontrolled infection or intercurrent illness including,
• but not limited to, ongoing or active infection, or psychiatric illness/social
• situations that would limit compliance with study requirements.
• Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
• Inability to comply with study and/or follow-up procedures.

Where it is running

• Cancer Center of Huntsville — Huntsville, Alabama, United States
• Clearview Cancer Institute — Huntsville, Alabama, United States
• University of Southern Alabama — Mobile, Alabama, United States
• Northeast Arkansas Clinic — Jonesboro, Arkansas, United States
• Wilshire Oncology Medical Group — La Verne, California, United States
• New Hope Cancer and Research Institute — Pomona, California, United States
• Eastern Connecticut Hematology Oncology — Norwich, Connecticut, United States
• Aventura Medical Center — Aventura, Florida, United States
• Lynn Cancer Institute — Boca Raton, Florida, United States
• Florida Cancer Care — Davie, Florida, United States
• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Memorial Regional Cancer Center — Hollywood, Florida, United States
• Integrated Community Oncology Network — Jacksonville, Florida, United States
• Watson Clinic Center for Cancer Care and Research — Lakeland, Florida, United States
• Space Coast Medical Associates — Titusville, Florida, United States
• Piedmont Healthcare — Atlanta, Georgia, United States
• Emory/Winship Cancer Institute — Atlanta, Georgia, United States
• Augusta Oncology Associates — Augusta, Georgia, United States
• Medical Oncology Associates of Augusta — Augusta, Georgia, United States
• Medical College of Georgia Cancer Specialists — Augusta, Georgia, United States
• Northeast Georgia Medical Center — Gainesville, Georgia, United States
• Suburban Hem Onc — Lawrenceville, Georgia, United States
• Mid-Illinois Hematology & Oncology — Normal, Illinois, United States
• Northeast Alabama Regional Medical Center — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.