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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00875979 |
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Date of registration:
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02/04/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1, T-DM1) in Combination With Pertuzumab Administered to Patients With Human Epidermal Growth Factor Receptor-2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer Who Have Previously Received Trastuzumab
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Scientific title:
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A Phase Ib/II, Open-label Study of the Safety, Tolerability, and Efficacy of Trastuzumab Emtansine (Trastuzumab-MCC-DM1, T-DM1) in Combination With Pertuzumab Administered Intravenously to Patients With Human Epidermal Growth Factor Receptor-2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer Who Have Previously Received Trastuzumab |
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Date of first enrolment:
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May 2009 |
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Target sample size:
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67 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00875979 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Belgium
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Canada
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France
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Germany
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Italy
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Spain
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United States
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Contacts
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Name:
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Elaine K. Wong, M.Sc., M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Genentech, Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Histologically documented human epidermal growth factor receptor 2 (HER2)-positive
locally advanced or metastatic breast cancer.
- Tumor tissue blocks or 15-20 unstained tissue slides for confirmatory central
laboratory HER2 status testing and other exploratory assessments.
- Prior trastuzumab in any line of therapy.
- No prior trastuzumab emtansine (T-DM1) or pertuzumab therapy.
- Measurable disease.
- For women of childbearing potential, agreement to use an effective form of
contraception and to continue its use for the duration of the study.
- Life expectancy = 90 days.
Exclusion Criteria:
- Less than 21 days since the last anti-tumor therapy, including chemotherapy, biologic,
experimental, immune, hormonal, or radiotherapy for the treatment of breast cancer,
with the following exceptions: Hormone-replacement therapy or oral contraceptives;
palliative radiation therapy involving = 25% of marrow-bearing bone if administered =
14 days prior to first study treatment.
- History of intolerance or hypersensitivity to trastuzumab and/or adverse events
related to trastuzumab that resulted in trastuzumab being permanently discontinued.
- Peripheral neuropathy of Grade = 2.
- History of clinically significant cardiac dysfunction.
- Current severe, uncontrolled systemic disease, eg, clinically significant
cardiovascular, pulmonary, or metabolic disease.
- Brain metastases that are untreated, progressive, or have required any type of therapy
to control symptoms from brain metastases within 60 days of the first study treatment.
- History of other malignancy within the last 5 years, except for appropriately treated
carcinoma in situ of the cervix, non-melanoma skin carcinoma, or other malignancy with
a similar expected curative outcome.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Metastatic Breast Cancer
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Intervention(s)
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Drug: Pertuzumab 420 mg
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Drug: Trastuzumab emtansine [Kadcyla] 3.0 mg/kg
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Drug: Trastuzumab emtansine [Kadcyla] 3.6 mg/kg
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Primary Outcome(s)
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Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
[Time Frame: Baseline through the end of the study (up to 2 years 3 months)]
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Secondary Outcome(s)
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Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
[Time Frame: Baseline through the end of the study (up to 2 years 3 months)]
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Progression-free Survival Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
[Time Frame: Baseline through the end of the study (up to 2 years 3 months)]
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Secondary ID(s)
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BO22495
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TDM4373g
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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