Safety Study of AMG 386 to Treat HER2-positive Locally Recurrent or Metastatic Breast Cancer
NCT ID: NCT00807859
Last Updated: 2022-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
65 participants
INTERVENTIONAL
2009-03-09
2015-10-19
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A1
AMG 386 10 mgkg, Paclitaxel and Trastuzumab
AMG 386 10 mg/kg IV QW, paclitaxel 80 mg/m2 IV QW, trastuzumab: initial dose 8 mg/kg IV week 1, then 6 mg/kg IV Q3W
Cohort A3
AMG 386 30 mg/kg, Paclitaxel and Trastuzumab
AMG 386 30 mg/kg IV QW, paclitaxel 80 mg/m2 IV QW, trastuzumab: initial dose 8 mg/kg IV week 1, then 6 mg/kg IV Q3W
Cohort B1
AMG 386 10 mg/kg, Capecitabine and Lapatinib
AMG 386 10 mg/kg IV QW, capecitabine 2000 mg/m2 divided into 2 doses given PO Q12 hrs, days 1-14 every 21 days, lapatinib 1250 mg PO QD
Cohort B3
AMG 386 30 mg/kg, Capecitabine and Lapatinib
AMG 386 30 mg/kg IV QW, capecitabine 2000 mg/m2 divided into 2 doses given PO Q12 hrs, days 1-14 every 21 days, lapatinib 1250 mg PO QD
Interventions
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AMG 386 30 mg/kg, Paclitaxel and Trastuzumab
AMG 386 30 mg/kg IV QW, paclitaxel 80 mg/m2 IV QW, trastuzumab: initial dose 8 mg/kg IV week 1, then 6 mg/kg IV Q3W
AMG 386 30 mg/kg, Capecitabine and Lapatinib
AMG 386 30 mg/kg IV QW, capecitabine 2000 mg/m2 divided into 2 doses given PO Q12 hrs, days 1-14 every 21 days, lapatinib 1250 mg PO QD
AMG 386 10 mgkg, Paclitaxel and Trastuzumab
AMG 386 10 mg/kg IV QW, paclitaxel 80 mg/m2 IV QW, trastuzumab: initial dose 8 mg/kg IV week 1, then 6 mg/kg IV Q3W
AMG 386 10 mg/kg, Capecitabine and Lapatinib
AMG 386 10 mg/kg IV QW, capecitabine 2000 mg/m2 divided into 2 doses given PO Q12 hrs, days 1-14 every 21 days, lapatinib 1250 mg PO QD
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
FEMALE
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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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
Pierre Bénite Cedex, , France
Research Site
Toulouse, , France
Countries
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References
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Kaufman PA, Wildiers H, Freyer G, Kemeny M, Goncalves A, Jerusalem G, Stopeck A, Vrindavanam N, Dalenc F, Nanayakkara N, Wu B, Pickett CA. Phase 1b Study of Trebananib Plus Paclitaxel and Trastuzumab in Patients With HER2-Positive Locally Recurrent or Metastatic Breast Cancer. Clin Breast Cancer. 2019 Feb;19(1):47-57. doi: 10.1016/j.clbc.2018.09.012. Epub 2018 Oct 9.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20062042
Identifier Type: -
Identifier Source: org_study_id
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