Phase I/II Trial of Sorafenib Plus Ixabepilone in HER2-Negative Metastatic Breast Cancer
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Official title
Phase I/II Trial of Sorafenib Plus Ixabepilone in HER2-Negative Metastatic Breast Cancer (MBC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
In this study, patients with metastatic HER2-negative breast cancer will receive treatment with ixabepilone and sorafenib until disease progression or unacceptable toxicity occurs. The Phase I portion of this study will determine the maximum tolerated doses (MTDs) of sorafenib and ixabepilone that may be used in combination for first- or second-line treatment of MBC. The MTDs identified in the Phase I portion of the study will be used in the Phase II portion which will evaluate the efficacy and safety of the combination of sorafenib and ixabepilone in patients who have received at least one prior chemotherapy treatment in either the adjuvant or neoadjuvant setting or following one prior MBC chemotherapy in MBC patients who had not received prior adjuvant or neoadjuvant breast cancer chemotherapy. This will be one of the initial trials investigating the use of this treatment combination for MBC. This trial will be conducted under the leadership of the Sarah Cannon Research Institute (SCRI) Oncology Research Consortium, a community-based, multi-center, clinical trial organization.
Study identification
- NCT ID
- NCT00825734
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 83 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2009 (Type not available)
- Primary completion
- Jun 2013 (Actual)
- Completion
- Aug 2014 (Actual)
- Last update posted
- Dec 22, 2014
2009 – 2014
United States locations
- U.S. sites
- 15
- U.S. states
- 12
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Florida Cancer Specialists | Fort Myers | Florida | 33916 | — |
| Providence Medical Group | Terre Haute | Indiana | 47802 | — |
| RHHP/ Hope Cancer Center | Terre Haute | Indiana | 47802 | — |
| Baptist Hospital East | Louisville | Kentucky | 40207 | — |
| Hematology Oncology Clinic, LLP | Baton Rouge | Louisiana | 70806 | — |
| Mercy Hospital | Portland | Maine | 04101 | — |
| Center for Cancer and Blood Disorders | Bethesda | Maryland | 20817 | — |
| National Capital Clinical Research Consortium | Bethesda | Maryland | 20817 | — |
| St. Louis Cancer Care | Chesterfield | Missouri | 63044 | — |
| Portsmouth Regional Hospital | Portsmouth | New Hampshire | 03801 | — |
| Hematology-Oncology Associates of Northern NJ | Morristown | New Jersey | 07962 | — |
| Oncology Hematology Care | Cincinnati | Ohio | 45242 | — |
| South Carolina Oncology Associates | Columbia | South Carolina | 29210 | — |
| Spartanburg Regional Medical Center | Spartanburg | South Carolina | — | — |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37023 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00825734, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 22, 2014 · Synced Nov 13, 2026
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