NCT00807859

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

Completed Phase 1 Last updated 8 November 2022

What this trial tests

Phase 1 trial testing AMG 386 30 mg/kg, Paclitaxel and Trastuzumab in Breast Cancer in 65 participants. Completed in 19 October 2015.

Timeline

9 March 2009

Primary endpoint
27 February 2014

19 October 2015

Quick facts

Lead sponsor	Amgen
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	65
Start date	9 March 2009
Primary completion	27 February 2014
Estimated completion	19 October 2015
Sites	23 locations across Belgium, France, United States

Drugs / interventions tested

• AMG 386 30 mg/kg, Paclitaxel and Trastuzumab — full drug profile →
• AMG 386 30 mg/kg, Capecitabine and Lapatinib — full drug profile →
• AMG 386 10 mgkg, Paclitaxel and Trastuzumab — full drug profile →
• AMG 386 10 mg/kg, Capecitabine and Lapatinib — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Breast Neoplasms — all drugs for Breast Neoplasms →
• Breast Tumors — all drugs for Breast Tumors →
• Cancer — all drugs for Cancer →

Sponsor

Amgen — full company profile →

Who can join

18 and older, female only, with Breast Cancer or Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting tumor cell motility to prevent metastasis.
   Palmer TD, Ashby WJ, Lewis JD, Zijlstra A. · · 2011 · cited 142× · PMID 21664937 · DOI 10.1016/j.addr.2011.04.008
2. Circulating inflammatory cells in patients with metastatic breast cancer: Implications for treatment.
   Gianni C, Palleschi M, Schepisi G, Casadei C, et al · · 2022 · cited 25× · PMID 36003772 · DOI 10.3389/fonc.2022.882896
3. TIE2 Induces Breast Cancer Cell Dormancy and Inhibits the Development of Osteolytic Bone Metastases.
   Drescher F, Juárez P, Arellano DL, Serafín-Higuera N, et al · · 2020 · cited 10× · PMID 32260072 · DOI 10.3390/cancers12040868
4. Efficacy and safety of adding an agent to bevacizumab/taxane regimens for the first-line treatment of Her2-negative patients with locally recurrent or metastatic breast cancer: results from seven randomized controlled trials.
   Liu X, Liu X, Qiao T, Chen W, et al · · 2016 · cited 3× · PMID 27445484 · DOI 10.2147/ott.s103954
5. Exploring angiogenic pathways in breast cancer: Clinicopathologic correlations and prognostic implications based on gene expression profiles from a large-scale genomic dataset.
   Ayoub NM, Sardiah S, Al-Share QY, Alkader MS. · · 2024 · PMID 39302921 · DOI 10.1371/journal.pone.0310557