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

Inclusion Criteria

• 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 1500/mm3
• Platelet count >=100,000/mm3
• Hemoglobin >9 g/dL
• Adequate liver function, defined by:
• AST and ALT 50% (or normal per institutional guidelines) by MUGA scan or echocardiogram (ECHO).
• Adequate recovery from recent surgery. At least 1 week must have elapsed from the time of a minor surgery (i.e., sentinel node biopsy, port-acath (placement); at least 3 weeks must have elapsed from the time of a major surgery (i.e., lumpectomy, partial or total mastectomy, axillary lymph node dissection, breast reconstruction procedure).
• Patients with previous history of invasive cancers (including breast cancer)

are eligible if definitive treatment was completed more than 5 years prior to

initiating current study treatment, and there is no evidence of recurrent disease.

• Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
• Patient must be accessible for treatment and follow-up.
• Women of childbearing potential must agree to use an acceptable method of birth control to avoid pregnancy for the duration of study treatment, and for 3 months thereafter.
• All patients must be able to understand the investigational nature of the

study and give written informed consent prior to study entry.

Exclusion Criteria

• 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