Phase III Trial Comparing Capecitabine in Combination With Sorafenib or Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer
Public ClinicalTrials.gov record NCT01234337. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III Randomized, Double Blind, Placebo-controlled Trial Comparing Capecitabine Plus Sorafenib Versus Capecitabine Plus Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of this phase-III trial is to compare the efficacy and safety of sorafenib in combination with capecitabine versus capecitabine in combination with placebo in the treatment of subjects with locally advanced or metastatic HER2-negative breast cancer who are resistant to or have failed prior taxane and an anthracycline or for whom further anthracycline therapy is not indicated. After signing consent there can be up to 28 days before starting the treatment during which time a number of tests will be carried out which will include tumor evaluations and medical history. The following tests and evaluations will have to be done within 7 days of the start of treatment,on Day 1 of every cycle and at the end of study: Electrocardiogram, blood tests, patient quality of life questionnaires and a complete physical exam and vital signs. Treatment will be given in 21 day cycles with sorafenib/placebo to be taken every day for 21 days and capecitabine to be taken for the first 14 days. Patients will come in weekly for the first 6 weeks and then on Day1 for every cycle after the first 2 cycles. During the weekly visits the subjects will be check for any side effects and blood draws will happen for the study on Day 1 of each cycle. Subjects will be followed for overall survival.
Study identification
- NCT ID
- NCT01234337
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 537 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
- Feb 20, 2011
- Primary completion
- May 11, 2014
- Completion
- Oct 19, 2017
- Last update posted
- Nov 5, 2018
2011 – 2017
United States locations
- U.S. sites
- 19
- U.S. states
- 16
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Greenbrae | California | 94904-2007 | — |
| Not listed | Sylmar | California | 91342 | — |
| Not listed | West Palm Beach | Florida | 33407 | — |
| Not listed | Joliet | Illinois | 60435 | — |
| Not listed | Evansville | Indiana | 47713 | — |
| Not listed | Louisville | Kentucky | 40207 | — |
| Not listed | Boston | Massachusetts | 02114 | — |
| Not listed | Boston | Massachusetts | 02115-6084 | — |
| Not listed | Jackson | Mississippi | 39202 | — |
| Not listed | Springfield | Missouri | 65804 | — |
| Not listed | Albuquerque | New Mexico | 87131 | — |
| Not listed | Lake Success | New York | 11042 | — |
| Not listed | Durham | North Carolina | 27710 | — |
| Not listed | Philadelphia | Pennsylvania | 19104 | — |
| Not listed | Bristol | Tennessee | 37620 | — |
| Not listed | Memphis | Tennessee | 38120 | — |
| Not listed | El Paso | Texas | 79905 | — |
| Not listed | Burlington | Vermont | 05405 | — |
| Not listed | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 134 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01234337, 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 Nov 5, 2018 · Synced Sep 29, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01234337 live on ClinicalTrials.gov.