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

Completed · Phase 1

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

In brief

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.

Key facts

Study ID: NCT00807859
Run by: Amgen
People needed: 65
Starts: 2009-03-09
Expected to finish: 2015-10-19
Last updated by the study team: 2022-11-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease not amenable to any local treatment with curative intent.
HER2-positive by FISH, CISH, or IHC 3+
ECOG performance status 0 or 1
Left ventricular ejection fraction greater than or equal to institutional lower limit of normal
Adequate laboratory studies (hematological, chemistries and urinalysis)
Life expectancy greater than or equal to 3 months
Cohort A only:
Trastuzumab naïve or trastuzumab in the neo-adjuvant setting
No clinically significant drop in cardiac function prior exposure to trastuzumab
No prior chemotherapy for metastatic or locally recurrent breast cancer
No prior lapatinib therapy
At least 3 weeks from enrollment since prior chemotherapeutic agents, including taxanes, in the neoadjuvant or adjuvant setting
At least 3 months from enrollment since prior trastuzumab in the neoadjuvant or adjuvant setting
Cohort B only:
Must have failed trastuzumab in the first-line metastatic setting. Trastuzumab must be discontinued for at least 3 weeks prior to enrollment
Must have received prior chemotherapy as adjuvant therapy or for metastatic disease
Prior chemotherapy treatment must be discontinued for at least 3 weeks prior to enrollment
No prior capecitabine
No prior lapatinib

You may not qualify if…

Inflammatory breast cancer
Central nervous system metastasis
Clinically significant cardiovascular disease
Radiation therapy ≤ 14 days prior to enrollment.
Concurrent anticoagulation therapy, excluding aspirin, anti-platelet agents, low molecular weight heparin or low dose warfarin per protocol.
Uncontrolled hypertension defined as diastolic blood pressure > 90 mmHg OR systolic blood pressure > 140 mmHg.
Subjects with a history of prior malignancy, except:
For Cohort B only:
Current or prior history of long QT syndrome
Baseline ECG report of QTc interval of > 480 milliseconds
Severe chronic liver disease (Child Pugh C)

Where it is running

Research Site — Tucson, Arizona, United States
Research Site — Boca Raton, Florida, United States
Research Site — Iowa City, Iowa, United States
Research Site — Boston, Massachusetts, United States
Research Site — Minneapolis, Minnesota, United States
Research Site — Lebanon, New Hampshire, United States
Research Site — Lebanon, New Hampshire, United States
Research Site — Albuquerque, New Mexico, United States
Research Site — Great Neck, New York, United States
Research Site — New City, New York, United States
Research Site — New York, New York, United States
Research Site — Nyack, New York, United States
Research Site — Middletown, Ohio, United States
Research Site — Leuven, Belgium
Research Site — Liège, Belgium
Research Site — Wilrijk, Belgium
Research Site — Bordeaux, France
Research Site — Caen, France
Research Site — La Roche-sur-Yon, France
Research Site — Marseille, France
Research Site — Nantes, France
Research Site — Toulouse, France

Full record on ClinicalTrials.gov

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