Status:
COMPLETED
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
Lead Sponsor:
Hoffmann-La Roche
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This was a multi-institutional, multinational, open-label, single-arm Phase Ib/II study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of trastuzumab emtansine (trastuzu...
Detailed Description
There were 2 phases in the study, a Dose Escalation phase (Phase 1b) and a Dose Expansion phase (Phase 2a). In the Dose Escalation phase, 3 patients were enrolled at the first dose level (3.0 mg/kg tr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00875979
Start Date
May 1 2009
End Date
August 1 2011
Last Update
December 24 2013
Active Locations (20)
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1
Boca Raton, Florida, United States, 33428
2
Deerfield Beach, Florida, United States, 33442
3
Maywood, Illinois, United States, 60153
4
Indianapolis, Indiana, United States, 46202