Study of Icrucumab (IMC-18F1) or Ramucirumab Drug Product (DP) in Combination With Capecitabine or Capecitabine on Previously Treated Breast Cancer Patients
Public ClinicalTrials.gov record NCT01234402. 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
An Open-Label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of Ramucirumab (IMC-1121B) Drug Product or Icrucumab (IMC-18F1) in Combination With Capecitabine or Capecitabine Monotherapy, in Unresectable, Locally Advanced or Metastatic Breast Cancer Patients Previously Treated With Anthracycline and Taxane Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
An open-label, multicenter, randomized, Phase 2 trial in which participant with unresectable, locally advanced or metastatic breast cancer who have been previously treated with anthracycline and taxane therapy receive ramucirumab DP or Icrucumab (IMC-18F1) administered on an every-21-day cycle (in combination with oral capecitabine therapy; capecitabine is administered twice a day on Days 1-14 of each cycle). Approximately 150 participants will be randomized in a 1:1:1 ratio to either ramucirumab DP or Icrucumab (IMC-18F1) in combination with capecitabine (Arm A and Arm B, respectively) or capecitabine monotherapy (Arm C). Randomization will be stratified by triple-negative receptor status (estrogen receptor-negative, progesterone receptor-negative, and human epidermal growth factor receptor-2 \[HER2/neu\]-negative) (yes/no) and receipt of prior antiangiogenic therapy. Treatment with the study medication(s) will continue until disease progression, the development of unacceptable toxicity, noncompliance or withdrawal of consent by the participant, or investigator decision. Capecitabine dose reductions in the setting of significant myelosuppression, hand-and-foot syndrome, or diarrhea will be required.
Study identification
- NCT ID
- NCT01234402
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 153 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 2011 (Type not available)
- Primary completion
- Oct 2013 (Actual)
- Completion
- Jul 2017 (Actual)
- Last update posted
- Aug 14, 2019
2011 – 2017
United States locations
- U.S. sites
- 20
- U.S. states
- 15
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| ImClone Investigational Site | Scottsdale | Arizona | 85259 | — |
| ImClone Investigational Site | Los Angeles | California | 90033 | — |
| ImClone Investigational Site | Jacksonville | Florida | 32224 | — |
| ImClone Investigational Site | Atlanta | Georgia | 30322 | — |
| ImClone Investigational Site | Augusta | Georgia | 30912 | — |
| ImClone Investigational Site | Chicago | Illinois | 60611 | — |
| ImClone Investigational Site | Indianapolis | Indiana | 46202 | — |
| ImClone Investigational Site | Baton Rouge | Louisiana | 70809 | — |
| ImClone Investigational Site | New York | New York | 10021 | — |
| ImClone Investigational Site | Stony Brook | New York | 11794 | — |
| ImClone Investigational Site | The Bronx | New York | 10461 | — |
| ImClone Investigational Site | Washington | North Carolina | 27889 | — |
| ImClone Investigational Site | Cincinnati | Ohio | 45242 | — |
| ImClone Investigational Site | Columbus | Ohio | 43219 | — |
| ImClone Investigational Site | Dallas | Texas | 75390 | — |
| ImClone Investigational Site | San Antonio | Texas | 78229 | — |
| ImClone Investigational Site | Salt Lake City | Utah | 84106 | — |
| ImClone Investigational Site | Richmond | Virginia | 23230 | — |
| ImClone Investigational Site | Spokane | Washington | 99208 | — |
| ImClone Investigational Site | Morgantown | West Virginia | 26506 | — |
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 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01234402, 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 Aug 14, 2019 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01234402 live on ClinicalTrials.gov.