Completed PHASE1 INTERVENTIONAL 4-arm NCT00807859

Safety Study of AMG 386 to Treat HER2-positive Locally Recurrent or Metastatic Breast Cancer

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

Sponsor: Amgen

Conditions Breast Cancer Breast Neoplasms Breast Tumors Cancer Locally Recurrent and Metastatic Breast Cancer Metastases Metastatic Cancer Oncology Solid Tumors Tumors

Interventions AMG 386 10 mg/kg, Capecitabine and Lapatinib AMG 386 10 mgkg, Paclitaxel and Trastuzumab AMG 386 30 mg/kg, Capecitabine and Lapatinib AMG 386 30 mg/kg, Paclitaxel and Trastuzumab

Updated 9 times since 2017 Last updated: Nov 4, 2022 Started: Mar 9, 2009 Primary completion: Feb 27, 2014 Completion: Oct 19, 2015

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on Breast Cancer and Breast Neoplasms, this trial is completed. The trial is conducted by Amgen and has accumulated 9 data snapshots since 2009. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

Change History

9 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE1
Sep 2024 — Sep 2025 [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Dec 2022 — Jul 2024 [monthly]

Completed PHASE1
Jan 2021 — Dec 2022 [monthly]

Completed PHASE1

▶ Show 4 earlier versions

May 2019 — Jan 2021 [monthly]

Completed PHASE1
Jun 2018 — May 2019 [monthly]

Completed PHASE1
Feb 2017 — Jun 2018 [monthly]

Completed PHASE1
Jan 2017 — Feb 2017 [monthly]

Completed PHASE1

First recorded

Mar 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Amgen

Data source: Amgen

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Albuquerque, United States , Boca Raton, United States , Bordeaux, France , Boston, United States , Caen, France , Great Neck, United States , Iowa City, United States , La Roche-sur-Yon, France , Lebanon, United States , Leuven, Belgium and 12 more locations