Ixabepilone and Cyclophosphamide as Neoadjuvant Therapy in HER-2 Negative Breast Cancer

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

We propose to evaluate ixabepilone in combination with cyclophosphamide for the neoadjuvant treatment of locally advanced breast cancer. In this regimen, ixabepilone is substituted for docetaxel, since preclinical and clinical studies suggest that ixabepilone is more active than either docetaxel or paclitaxel. The combination of ixabepilone and cyclophosphamide could further improve the efficacy of non-anthracycline neoadjuvant therapy.

Key facts

Study ID

NCT00866905

Run by

SCRI Development Innovations, LLC

People needed

168

Starts

2009-04-01

Expected to finish

2014-10-01

Last updated by the study team

2021-11-22

Who can join

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

You may qualify if…

• Female patients, age ≥18 years.
• Histologically confirmed invasive adenocarcinoma of the breast.
• Primary palpable disease confined to a breast and axilla on
• physical examination. For patients without clinically suspicious
• axillary adenopathy, the primary tumor must be larger than 2 cm
• in diameter by physical exam or imaging studies (clinical T2-T3,
• N0-N1, M0). For patients with clinically suspicious axillary
• adenopathy, the primary breast tumor can be any size (clinical
• T1-3, N1-2, M0). (T1N0M0 lesions are excluded.)
• Patients without clearly defined palpable breast mass or axillary
• lymph nodes but radiographically measurable tumor masses are
• acceptable. Accepted procedures for measuring breast disease
• are mammography, MRI, and breast ultrasound. This will need to
• be re-evaluated after 3 cycles and prior to surgery.
• Eastern Cooperative Oncology Group performance status (ECOG
• PS) 0-2.
• No metastatic disease, as documented by complete staging workup
• 6 weeks prior to initiation of study treatment.
• No previous treatment for breast cancer.
• HER2-negative tumor status. HER2-negative is defined as:
• Immunohistochemical (IHC) 0, IHC 1+ OR
• IHC 2+ or IHC 3+ must be confirmed as FISH (fluorescence in situ
• hybridization) negative (defined by ratio <2.2).
• Adequate hematologic function with:
• Absolute neutrophil count (ANC) >1500/μL.

You may not qualify if…

• Inflammatory breast cancer.
• Peripheral neuropathy (motor or sensory) ≥ grade 1 by the
• Common Terminology Criteria for Adverse Events version 3.0
• (CTCAE v 3.0).
• Prior radiation that included ≥30% of major bone marrow containing
• areas (pelvis, lumbar, spine).
• Chronic use of cytochrome P450 (CYP) 3A4 inhibitors and use of
• the following strong CYP3A4 inhibitors: ketoconazole,
• itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir,
• telithromycin, ritonavir, amprenavir, indinavir, nelfinavir,
• delavirdine, and voriconazole. Use of these agents should be
• discontinued at least 72 hours prior to initiation of study treatment.
• Chemotherapy within 5 years of starting study treatment except
• for low doses of agents used for anti-inflammatory indications
• such as rheumatoid arthritis, psoriasis, and connective tissue
• disorders. Although such doses and schedules cannot result in
• myelosuppression, patients must discontinue this therapy while
• they are receiving study treatment.
• Known or suspected hypersensitivity to Cremophor®EL
• (polyoxyethylated castor oil) or a drug formulated in
• Cremophor®EL such as paclitaxel, or any other agent given in the
• course of this study.
• Pregnancy or breast-feeding. A negative serum pregnancy test
• within 7 days prior to first study treatment (Day 1, Cycle 1) for all
• women of childbearing potential is required. Patients of

Where it is running

• Aventura Medical Center — Aventura, Florida, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Watson Clinic Center for Cancer Care and Research — Lakeland, Florida, United States
• Medical Oncology Associates of Augusta — Augusta, Georgia, United States
• Northeast Georgia Medical Center — Gainesville, Georgia, United States
• Providence Medical Group — Terre Haute, Indiana, United States
• Mercy Hospital — Portland, Maine, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• National Capital Clinical Research Consortium — Bethesda, Maryland, United States
• St. Louis Cancer Care — Chesterfield, Missouri, United States
• Methodist Cancer Center — Omaha, Nebraska, United States
• Hematology Oncology Associates of Northern NJ — Morristown, New Jersey, United States
• Oncology Hematology Care — Cincinnati, Ohio, United States
• Cancer Centers of Southwest Oklahoma — Lawton, Oklahoma, United States
• South Carolina Oncology Associates, PA — Columbia, South Carolina, United States
• Chattanooga Oncology Hematology Associates — Chattanooga, Tennessee, United States
• Family Cancer Center — Collierville, Tennessee, United States
• Tennessee Oncology — Nashville, Tennessee, United States
• South Texas Oncology and Hematology — San Antonio, Texas, United States
• Virginia Cancer Institute — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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