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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Breast Cancer

Thank you

Trial Information

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


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.

Type of Study:

Expanded Access

Study Design:

N/A

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

TDM4884g

NCT ID:

NCT01120561

Start Date:

May 2010

Completion Date:

Related Keywords:

  • Metastatic Breast Cancer
  • TDM-1 EAP
  • T-DM1 EAP
  • TDM1 EAP
  • Trastuzumab-MCC-DM1 EAP
  • Trastuzumab emtansine
  • EAP
  • T-PAS
  • Breast Neoplasms

Name

Location

Investigational siteSeattle, Washington  98166
Investigational SiteAurora, Colorado  80045
Investigational SiteBaltimore, Maryland  21204
Investigational SiteDuarte, California  91010-3000
Investigational SiteDurham, North Carolina  27710
Investigational SiteLansing, Michigan  48912
Investigational SiteOcala, Florida  
Investigational SiteLafayette, Indiana  47905
Investigational SiteSt. Louis, Missouri  63110
Investigational SiteCedar Rapids, Iowa  52403
Investigational SiteCharleston, South Carolina  29414
Investigational SiteFairfax, Virginia  22031
Investigational SiteScarborough, Maine  04074
Investigational SiteFarmington, New Mexico  87401