Metastatic Breast CancerNCT01120561
A Study of Trastuzumab-MCC-DM1 in Patients With HER2- Positive Locally Advanced or Metastatic Breast Cancer
A study testing trastuzumab-MCC-DM1 in people with Metastatic Breast Cancer, run by Genentech, Inc. at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- trastuzumab-MCC-DM1
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 15 sitesUnited States
- Study dates
- May 2010to not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Investigational Site
Baltimore, Maryland, 21231
Investigational Site
Cedar Rapids, Iowa, 52403
Investigational Site
Charleston, South Carolina, 29403
Investigational Site
Charlotte, North Carolina, 28203
Investigational Site
Clarkson Valley, Missouri, 63011
Investigational Site
Denver, Colorado, 80220
Investigational Site
Detroit, Michigan, 48201
Investigational Site
Fairfax, Virginia, 22031
Investigational Site
Farmington, New Mexico, 87401
Investigational Site
Highland, California, 92346
Investigational Site
Lafayette, Indiana, 47905
Investigational Site
Plantation, Florida, 33324
Investigational Site
Scarborough, Maine, 04074
Investigational Site
Seattle, Washington, 98109
Investigational Site
Stockton, California, 95204
About this study
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
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.
- Conditions
- Metastatic Breast Cancer
- Being tested
- trastuzumab-MCC-DM1
- Keywords
- TDM-1 EAP, T-DM1 EAP, TDM1 EAP, Trastuzumab-MCC-DM1 EAP, Trastuzumab emtansine, EAP, T-PAS
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trastuzumab-MCC-DM1Drug
Intravenous repeating dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2010 (estimated)
- Study startMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120561
- Sponsor's protocol ID
- TDM4884g
- Status last verified
- Feb 2017
- First submitted
- 7 May 2010
- Last updated
- 15 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01120561
- Acronym / sponsor ID
- TDM4884g
- Conditions
- Metastatic Breast Cancer
- Keywords
- TDM-1 EAP, T-DM1 EAP, TDM1 EAP, Trastuzumab-MCC-DM1 EAP, Trastuzumab emtansine, EAP, T-PAS
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2010
- First posted
- 11 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trastuzumab-MCC-DM1Intravenous repeating dose | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trastuzumab-MCC-DM1 in people with Metastatic Breast Cancer, run by Genentech, Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2017.