Breast Cancer Clinical Trial
Safety Study of AMG 386 to Treat HER2-positive Locally Recurrent or Metastatic Breast Cancer
Summary
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.
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
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There are 22 Locations for this study
Tucson Arizona, 85724, United States
Boca Raton Florida, 33428, United States
Iowa City Iowa, 52242, United States
Boston Massachusetts, 02111, United States
Minneapolis Minnesota, 55407, United States
Lebanon New Hampshire, 03756, United States
Lebanon New Hampshire, 03756, United States
Albuquerque New Mexico, 87131, United States
Great Neck New York, 11021, United States
New City New York, 10956, United States
New York New York, 10032, United States
Nyack New York, 10960, United States
Middletown Ohio, 45042, United States
Leuven , 3000, Belgium
Liege , 4000, Belgium
Wilrijk , 2610, Belgium
Bordeaux , 33075, France
Caen Cedex 05 , 14076, France
La Roche Sur Yon Cedex 9 , 85925, France
Marseille , 13009, France
Nantes Cedex 2 , 44202, France
Pierre Bénite Cedex , 69495, France
Toulouse , 31052, France
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