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Sponsors and Collaborators: |
Sarah Cannon Research Institute SCRI Oncology Research Consortium Bristol-Myers Squibb Genentech |
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Information provided by: | Sarah Cannon Research Institute |
ClinicalTrials.gov Identifier: | NCT00821886 |
In this phase II trial the investigators propose to evaluate ixabepilone in combination with carboplatin and trastuzumab as neoadjuvant therapy in locally advanced breast cancer patients. Patients with early stage, HER2-positive breast cancer will receive six cycles of neoadjuvant treatment with ixabepilone, carboplatin, and trastuzumab every three weeks prior to surgery; after surgery, patients will continue treatment with trastuzumab every three weeks until week 52. Concomitant with the post-operative trastuzumab treatment, patients with hormone receptor-positive tumors will receive anti-estrogen treatment. Also, after the completion of chemotherapy, patients may receive radiation treatment at the discretion of their physician.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Ixabepilone Drug: Trastuzumab Drug: Carboplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Neoadjuvant Ixabepilone/Carboplatin/Trastuzumab in HER2-Positive Locally Advanced Breast Cancer |
Estimated Enrollment: | 60 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Neoadjuvant Treatment, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate
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Drug: Ixabepilone
Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)
Drug: Trastuzumab
Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52
Drug: Carboplatin
Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Normal bone marrow function as defined by:
Normal hepatic function as defined by:
For patients with previous invasive cancers (including breast cancer) treated with curative intent, completion of chemotherapy or radiation therapy more than 5 years prior to enrollment for this study and no evidence of recurrent disease. Patients may be receiving anti-estrogen hormonal therapy prescribed for previous invasive breast cancer as long as the diagnosis of invasive cancer was made more than 5 years prior to study enrollment.
Patients may be using anti-estrogen hormonal therapy at the time of current diagnosis but must discontinue this therapy before beginning study treatment.
Exclusion Criteria:
History of significant cardiac disease or cardiac risk factors or the following:
Contact: Denise Yardley, M.D. | (615) 329-7274 | dyardley@tnonc.com |
Contact: Trials Info | (615) 329-7274 | trialsinfo@scresearch.net |
United States, Florida | |
Florida Cancer Specialists | Recruiting |
Fort Myers, Florida, United States, 33901 | |
Contact: Katie Goodman 239-274-9930 KatieG@flcancer.com | |
United States, Maine | |
Mercy Hospital | Recruiting |
Portland, Maine, United States, 04101 | |
United States, Maryland | |
Center for Cancer and Blood Disorders | Recruiting |
Bethesda, Maryland, United States, 20817 | |
United States, Missouri | |
St. Louis Cancer Care | Recruiting |
Chesterfield, Missouri, United States, 63017 | |
United States, New Jersey | |
Hematology Oncology Associates of Northern NJ | Recruiting |
Morristown, New Jersey, United States, 07960 | |
United States, Tennessee | |
Tennessee Oncology, PLLC | Recruiting |
Nashville, Tennessee, United States, 37023 | |
United States, Virginia | |
Virginia Cancer Institute | Recruiting |
Richmond, Virginia, United States, 23235 |
Study Chair: | Denise Yardley, M.D. | SCRI Oncology Research Consortium |
Responsible Party: | SCRI Oncolgy Research Consortium ( Denise Yardley, M.D. ) |
Study ID Numbers: | SCRI BRE 139 |
Study First Received: | January 12, 2009 |
Last Updated: | May 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00821886 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Breast Cancer Neoadjuvant Ixabepilone Carboplatin Trastuzumab |
Skin Diseases Epothilones Tubulin Modulators Trastuzumab |
Breast Neoplasms Antimitotic Agents Carboplatin Breast Diseases |
Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Epothilones Mitosis Modulators Breast Neoplasms Carboplatin Antimitotic Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Trastuzumab Breast Diseases |