A Study of Trastuzumab-MCC-DM1 in Patients With HER2- Positive Locally Advanced or Metastatic Breast Cancer

Study Overview
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Brief Summary
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This is a multicenter, open-label, single-arm, expanded access study designed to provide T-DM1 to patients with HER2-positive locally advanced or metastatic breast cancer and to evaluate the safety and efficacy of T-DM1 administered by intravenous (IV) infusion.

Official Title
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An Expanded Access, Open-Label Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2- Positive Locally Advanced or Metastatic Breast Cancer

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Drug: trastuzumab-MCC-DM1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically documented breast cancer Locally advanced or metastatic breast cancer HER2-positive breast cancer documented as FISH-positive, IHC 3 + or CISH-positive by local laboratory assessment Histologically or cytologically confirmed invasive breast cancer: incurable, unresectable, locally advanced breast cancer previously treated with multimodality therapy or metastatic breast cancer Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced, or metastatic setting must include both: a taxane, alone or in combination with another agent, and Trastuzumab, alone or in combination with another agent in the adjuvant, unresectable, locally advanced, or metastatic setting Documented progression of incurable unresectable, locally advanced, or metastatic breast cancer during their most recent treatment regimen Progression must occur during or after most recent treatment for locally advanced/metastatic breast cancer or within 6 months after completing adjuvant therapy Adequate hematologic and end organ function Agreement to use an effective form of birth control throughout the study Life expectancy ≥ 90 days as assessed by the investigator Exclusion Criteria: Less than 14 days from the first study treatment since the last anti-cancer therapy, including chemotherapy, biologic, experimental, immune, hormonal or endocrine therapy Prior T-DM1 therapy History of exposure to cumulative doses of select anthracyclines History of intolerance or hypersensitivity to trastuzumab, murine proteins, or any of the excipients, that resulted in trastuzumab being permanently discontinued Brain metastases that are untreated or progressive or currently require any type of therapy, including radiation, surgery, and/or steroids to control symptoms from brain metastases within 30 days before the first study treatment Peripheral neuropathy of Grade ≥ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0, at the time of the first study treatment History of clinically significant cardiac dysfunction Current known active infection with HIV, hepatitis B virus, or hepatitis C virus Current severe, uncontrolled systemic disease Major surgical procedure or significant traumatic injury within 28 days prior to first study treatment Pregnancy or lactation NOTE: The site selection process has been completed. Patients can enroll at participating sites.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: trastuzumab-MCC-DM1|Intravenous repeating dose|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TDM-1 EAP, T-DM1 EAP, TDM1 EAP, Trastuzumab-MCC-DM1 EAP, Trastuzumab emtansine, EAP, T-PAS