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.

View Eligibility Criteria

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)

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

65

Study ID:

NCT00807859

Recruitment Status:

Completed

Sponsor:

Amgen

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There are 22 Locations for this study

See Locations Near You

Research Site
Tucson Arizona, 85724, United States
Research Site
Boca Raton Florida, 33428, United States
Research Site
Iowa City Iowa, 52242, United States
Research Site
Boston Massachusetts, 02111, United States
Research Site
Minneapolis Minnesota, 55407, United States
Research Site
Lebanon New Hampshire, 03756, United States
Research Site
Lebanon New Hampshire, 03756, United States
Research Site
Albuquerque New Mexico, 87131, United States
Research Site
Great Neck New York, 11021, United States
Research Site
New City New York, 10956, United States
Research Site
New York New York, 10032, United States
Research Site
Nyack New York, 10960, United States
Research Site
Middletown Ohio, 45042, United States
Research Site
Leuven , 3000, Belgium
Research Site
Liege , 4000, Belgium
Research Site
Wilrijk , 2610, Belgium
Research Site
Bordeaux , 33075, France
Research Site
Caen Cedex 05 , 14076, France
Research Site
La Roche Sur Yon Cedex 9 , 85925, France
Research Site
Marseille , 13009, France
Research Site
Nantes Cedex 2 , 44202, France
Research Site
Pierre Bénite Cedex , 69495, France
Research Site
Toulouse , 31052, France

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

65

Study ID:

NCT00807859

Recruitment Status:

Completed

Sponsor:


Amgen

How clear is this clinincal trial information?

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