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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


Phase 1
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Breast Neoplasms, Breast Tumors, Cancer, Locally Recurrent and Metastatic Breast Cancer, Metastases, Metastatic Cancer, Oncology, Solid Tumors, Tumors

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Trial Information

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


Inclusion Criteria:



- Subjects must have histologically or cytologically confirmed adenocarcinoma of the
breast with locally recurrent or metastatic disease. Locally recurrent disease must
not be 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:

- Subjects must be either trastuzumab naïve or have had prior trastuzumab in the
neo-adjuvant setting only

- Subjects must not have had a clinically significant drop in cardiac function during a
prior exposure to trastuzumab

- Subjects must have had no prior chemotherapy for metastatic or locally recurrent
breast cancer

- Subjects must have had 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:

- Subjects must have failed (due to disease progression or toxicity) trastuzumab in the
first-line metastatic setting. Trastuzumab must be discontinued for at least 3 weeks
prior to enrollment

- Subjects 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

- Subjects must have had no prior capecitabine

- Subjects must have had no prior lapatinib

Exclusion Criteria:

- Inflammatory breast cancer

- Current or prior history of central nervous system metastasis

- Clinically significant cardiovascular disease

- Radiation therapy ≤ 14 days prior to enrollment. Subjects must have recovered from
all radiation therapy related toxicities.

- Concurrent or prior (within 1 week before enrollment) anticoagulation therapy,
excluding aspirin and anti-platelet agents. The concurrent use of low molecular
weight heparin or low dose warfarin (ie, less than or equal to 1 mg daily) for
prophylaxis against thrombosis is acceptable while on study

- Uncontrolled hypertension defined as diastolic blood pressure > 90 mmHg OR systolic
blood pressure > 140 mmHg. The use of anti-hypertensive medications to control
hypertension is permitted.

- Subjects with a history of prior malignancy, except:

- Malignancy treated with curative intent and with no known active disease present for
greater than or equal to 3 years before enrollment and felt to be at low risk for
recurrence by treating physician

- Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence
of disease

- Adequately treated cervical carcinoma in situ without evidence of disease

- Subjects with interstitial pulmonary disease

- 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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary objective is to identify the incidence of adverse events and clinical laboratory abnormalities defined as a dose limiting toxicity in subjects treated with AMG 386 plus paclitaxel and trastuzumab or with AMG 386 plus capecitabine and lapatinib

Outcome Time Frame:

24 months

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20062042

NCT ID:

NCT00807859

Start Date:

March 2009

Completion Date:

April 2014

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms
  • Breast Tumors
  • Cancer
  • Locally Recurrent and Metastatic Breast Cancer
  • Metastases
  • Metastatic Cancer
  • Oncology
  • Solid Tumors
  • Tumors
  • AMG 386
  • Paclitaxel
  • Trastuzumab
  • Capecitabine
  • Lapatinib
  • HER2-positive
  • metastatic breast cancer
  • locally recurrent breast cancer
  • Taxol
  • Herceptin
  • Xeloda
  • Tykerb
  • anti-angiogenic therapy
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary

Name

Location

Research SiteMesa, Arizona  
Research SiteBoca Raton, Florida  
Research SiteAmes, Iowa  
Research SiteBeverly, Massachusetts  
Research SiteAlexandria, Minnesota  
Research SiteHooksett, New Hampshire  
Research SiteAlbuquerque, New Mexico  
Research SiteAlbany, New York  
Research SiteAkron, Ohio