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A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment
A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment
CompletedPhase 3
Sponsor: Hoffmann-La Roche
Conditions: Breast Cancer
Interventions: Trastuzumab Emtansine
Countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China
This two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general participant population; Cohort 2 will include only Asian participants.
Eligibility overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * HER2-positive disease determined locally * Histologically or cytologically confirmed invasive breast cancer * Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced or metastatic setting must include both chemotherapy, alone or in combination with another agent, and an anti-HER2 agent, alone or in combination with another agent * Documented progression of incurable, unresectable, LABC, or mBC, defined by the investigator: progression must occur during or after most recent treatment for LABC/mBC or within 6 months of completing adjuvant therapy * Measurable and/or non-measurable disease * Left ventricular ejection fraction (LVEF) \>/=50% by either echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) * Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2 * Adequate organ function * Use of highly effective contraception as defined by the protocol Exclusion Criteria: * History of treatment with trastuzumab emtansine * Prior enrollment into a clinical study containing trastuzumab emtansine regardless of having received trastuzumab emtansine or not * Peripheral neuropathy of Grade \>/= 3 per National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) v 4.0 * History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive breast cancer * History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to first study treatment except hormone therapy, which can be given up to 7 days prior to first study treatment; recovery of treatment-related toxicity consistent with other eligibility criteria * History of exposure to cumulative doses of anthracyclines * History of radiation therapy within 14 days of first study treatment. The participant must have recovered from any resulting acute toxicity (to Grade \</=1) prior to first study treatment. * Metastatic central nervous system (CNS) disease only * Brain metastases which are symptomatic * History of a decrease in LVEF to less than (\<) 40% or symptomatic congestive heart failure (CHF) with previous trastuzumab treatment * History of symptomatic CHF (New York Heart Association \[NYHA\] Classes II-IV) or serious cardiac arrhythmia requiring treatment * History of myocardial infarction or unstable angina within 6 months of first study treatment * Current dyspnea at rest due to complications of advanced malignancy or requirement for continuous oxygen therapy * Current severe, uncontrolled systemic disease (clinically significant cardiovascular, pulmonary, or metabolic disease) * Pregnancy or lactation * Currently known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus * History of intolerance (such as Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins or any component of the product
Locations (300)
- Buenos Aires, Argentina
- La Rioja, Argentina
- Mar del Plata, Argentina
- North Sydney, New South Wales, Australia
- Waratah, New South Wales, Australia
- Westmead, New South Wales, Australia
- South Brisbane, Queensland, Australia
- Kurralta Park, South Australia, Australia
- Melbourne, Victoria, Australia
- St Albans, Victoria, Australia
- Murdoch, Western Australia, Australia
- Salzburg, Austria
- Vienna, Austria
- Vienna, Austria
- Anderlecht, Belgium
- Brussels, Belgium
- Brussels, Belgium
- Charleroi, Belgium
- Edegem, Belgium
- Ghent, Belgium
- Leuven, Belgium
- Liège, Belgium
- Namur, Belgium
- Wilrijk, Belgium
- Rio de Janeiro, Rio de Janeiro, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- Florianópolis, Santa Catarina, Brazil
- São Paulo, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- Sofia, Bulgaria
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