Trial of Paclitaxel/Bevacizumab +/- Everolimus for Patients With HER2-Negative Metastatic Breast Cancer
Public ClinicalTrials.gov record NCT00915603. 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 Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Weekly Paclitaxel/Bevacizumab +/- Everolimus as First-Line Chemotherapy for Patients With HER2-Negative Metastatic Breast Cancer (MBC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This randomized, double blind, placebo controlled trial will evaluate the impact of adding everolimus to the combination of weekly paclitaxel plus bevacizumab in the first-line treatment of women with HER2-negative metastatic breast cancer. Patients will be randomized (1:1) to receive either paclitaxel/bevacizumab/everolimus (Treatment Arm 1) or paclitaxel/ bevacizumab/placebo (Treatment Arm 2). Patients will be evaluated for response to treatment every 8 weeks; responding and/or stable patients will continue treatment, with re-evaluations every 8 weeks, until tumor progression or intolerable toxicity occurs. Outcomes will be assessed for each treatment arm separately. This trial is not intended to compare treatment arms primarily. Any such analyses are exploratory and will be conducted without adjustment for multiple hypothesis testing.
Study identification
- NCT ID
- NCT00915603
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 113 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
- Jul 2009 (Type not available)
- Primary completion
- Jun 2014 (Actual)
- Completion
- Jul 2014 (Actual)
- Last update posted
- Dec 22, 2014
2009 – 2014
United States locations
- U.S. sites
- 15
- U.S. states
- 10
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Wilshire Oncology Medical Group | LaVerne | California | 91750 | — |
| Eastern Connecticut Hematology Oncology | Norwich | Connecticut | 06360 | — |
| Aventura Medical Center | Aventura | Florida | 33180 | — |
| Florida Cancer Specialists | Fort Myers | Florida | 33901 | — |
| Mercy Hospital | Portland | Maine | 04101 | — |
| Center for Cancer and Blood Disorders | Bethesda | Maryland | 20817 | — |
| National Capital Clinical Research Associates | Bethesda | Maryland | 20817 | — |
| Oncology Hematology Care | Cincinnati | Ohio | 45242 | — |
| Mid Ohio Oncology/Hematology, Inc./ The Mark H. Zangmeister Center | Columbus | Ohio | 43219 | — |
| South Carolina Oncology Associates, PA | Columbia | South Carolina | 29210 | — |
| Chattanooga Oncology Hematology Associates | Chattanooga | Tennessee | 37404 | — |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37023 | — |
| Texas Oncology | Dallas | Texas | 75246 | — |
| Fairfax Northern Virginia Hem-Onc | Fairfax | Virginia | 22031 | — |
| Virginia Cancer Institute | Richmond | Virginia | 23235 | — |
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 NCT00915603, 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 Oct 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00915603 live on ClinicalTrials.gov.