Safety Study of AMG 386 to Treat HER2-positive Locally Recurrent or Metastatic Breast Cancer
Public ClinicalTrials.gov record NCT00807859. 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 Study of AMG 386 in Combination With Either Paclitaxel and Trastuzumab or Capecitabine and Lapatinib in Subjects With HER2-positive Locally Recurrent or Metastatic Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine if AMG 386 in combination with either paclitaxel and trastuzumab or capecitabine and lapatinib is safe and well tolerated in subjects with HER2-positive locally recurrent or metastatic breast cancer. This is an open-label phase 1b trial and has 2 study parts. Study part 1 is a dose escalation study to determine a tolerable dose of AMG 386 in combination with paclitaxel and trastuzumab (cohort A) or with capecitabine and lapatinib (cohort B). Study part 2 is cohort expansion of the tolerable doses determined in part 1.
Study identification
- NCT ID
- NCT00807859
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 65 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- 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 9, 2009 (Actual)
- Primary completion
- Feb 27, 2014 (Actual)
- Completion
- Oct 19, 2015 (Actual)
- Last update posted
- Nov 8, 2022
2009 – 2015
United States locations
- U.S. sites
- 13
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Tucson | Arizona | 85724 | — |
| Research Site | Boca Raton | Florida | 33428 | — |
| Research Site | Iowa City | Iowa | 52242 | — |
| Research Site | Boston | Massachusetts | 02111 | — |
| Research Site | Minneapolis | Minnesota | 55407 | — |
| Research Site | Lebanon | New Hampshire | 03756-0001 | — |
| Research Site | Lebanon | New Hampshire | 03756 | — |
| Research Site | Albuquerque | New Mexico | 87131 | — |
| Research Site | Great Neck | New York | 11021 | — |
| Research Site | New City | New York | 10956 | — |
| Research Site | New York | New York | 10032 | — |
| Research Site | Nyack | New York | 10960 | — |
| Research Site | Middletown | Ohio | 45042 | — |
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 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00807859, 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 8, 2022 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00807859 live on ClinicalTrials.gov.