A Study of Trastuzumab-MCC-DM1 in Patients With HER2- Positive Locally Advanced or Metastatic Breast Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01120561 |
Expanded Access Status :
No longer available
First Posted : May 11, 2010
Last Update Posted : February 15, 2017
|
- Study Details
- Tabular View
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Metastatic Breast Cancer | Drug: trastuzumab-MCC-DM1 |
Study Type : | Expanded Access |
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 Start Date : | May 2010 |

- Drug: trastuzumab-MCC-DM1
Intravenous repeating dose

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01120561
United States, California | |
Investigational Site | |
Highland, California, United States, 92346 | |
Investigational Site | |
Stockton, California, United States, 95204 | |
United States, Colorado | |
Investigational Site | |
Denver, Colorado, United States, 80220 | |
United States, Florida | |
Investigational Site | |
Plantation, Florida, United States, 33324 | |
United States, Indiana | |
Investigational Site | |
Lafayette, Indiana, United States, 47905 | |
United States, Iowa | |
Investigational Site | |
Cedar Rapids, Iowa, United States, 52403 | |
United States, Maine | |
Investigational Site | |
Scarborough, Maine, United States, 04074 | |
United States, Maryland | |
Investigational Site | |
Baltimore, Maryland, United States, 21231 | |
United States, Michigan | |
Investigational Site | |
Detroit, Michigan, United States, 48201 | |
United States, Missouri | |
Investigational Site | |
Clarkson Valley, Missouri, United States, 63011 | |
United States, New Mexico | |
Investigational Site | |
Farmington, New Mexico, United States, 87401 | |
United States, North Carolina | |
Investigational Site | |
Charlotte, North Carolina, United States, 28203 | |
United States, South Carolina | |
Investigational Site | |
Charleston, South Carolina, United States, 29403 | |
United States, Virginia | |
Investigational Site | |
Fairfax, Virginia, United States, 22031 | |
United States, Washington | |
Investigational Site | |
Seattle, Washington, United States, 98109 |
Study Director: | Clinical Trials | Genentech, Inc. |
Responsible Party: | Genentech, Inc. |
ClinicalTrials.gov Identifier: | NCT01120561 |
Other Study ID Numbers: |
TDM4884g |
First Posted: | May 11, 2010 Key Record Dates |
Last Update Posted: | February 15, 2017 |
Last Verified: | February 2017 |
TDM-1 EAP T-DM1 EAP TDM1 EAP Trastuzumab-MCC-DM1 EAP |
Trastuzumab emtansine EAP T-PAS |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Trastuzumab Ado-trastuzumab emtansine |
Antineoplastic Agents, Immunological Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |