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
Study identification
- NCT ID
- NCT00807859
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- Amgen
- Industry
- Enrollment
- 65 participants
Conditions and interventions
Conditions
Interventions
- AMG 386 10 mg/kg, Capecitabine and Lapatinib Drug
- AMG 386 10 mgkg, Paclitaxel and Trastuzumab Drug
- AMG 386 30 mg/kg, Capecitabine and Lapatinib Drug
- AMG 386 30 mg/kg, Paclitaxel and Trastuzumab Drug
Drug
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 8, 2009
- Primary completion
- Feb 26, 2014
- Completion
- Oct 18, 2015
- Last update posted
- Nov 7, 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 7, 2022 · Synced May 4, 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 protocol, eligibility criteria, and contact information for NCT00807859 live on ClinicalTrials.gov.