Clinical trial NCT01120561: A Study of Trastuzumab-MCC-DM1 in Patients With HER2- Positive Locally Advanced or Metastatic Breast Cancer
Official title: An Expanded Access, Open-Label Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2- Positive Locally Advanced or Metastatic Breast Cancer
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Metastatic Breast Cancer
Keywords: TDM-1 EAP
T-DM1 EAP
TDM1 EAP
Trastuzumab-MCC-DM1 EAP
Trastuzumab emtansine
EAP
T-PAS
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Highland
country: United States
facility: Investigational Site
state: California
city: Stockton
country: United States
facility: Investigational Site
state: California
city: Denver
country: United States
facility: Investigational Site
state: Colorado
city: Plantation
country: United States
facility: Investigational Site
state: Florida
city: Lafayette
country: United States
facility: Investigational Site
state: Indiana
city: Cedar Rapids
country: United States
facility: Investigational Site
state: Iowa
city: Scarborough
country: United States
facility: Investigational Site
state: Maine
city: Baltimore
country: United States
facility: Investigational Site
state: Maryland
city: Detroit
country: United States
facility: Investigational Site
state: Michigan
city: Clarkson Valley
country: United States
facility: Investigational Site
state: Missouri
city: Farmington
country: United States
facility: Investigational Site
state: New Mexico
city: Charlotte
country: United States
facility: Investigational Site
state: North Carolina
city: Charleston
country: United States
facility: Investigational Site
state: South Carolina
city: Fairfax
country: United States
facility: Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Investigational Site
state: Washington
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: