Breast CancerPhase 1NCT01513083
A Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function
A Phase 1 study testing trastuzumab emtansine in people with Breast Cancer, run by Hoffmann-La Roche at 13 sites in 5 countries.
Trial summary
This open-label, parallel group study will evaluate the pharmacokinetics and safety of trastuzumab emtansine in patients with HER2-positive metastatic breast cancer and normal or reduced hepatic function. Patients will receive trastuzumab emtansine intravenously on Day 1 of each 3-week cycle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- trastuzumab emtansine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 13 sitesin 5 countries
- Study dates
- Feb 2012to Sep 2014
- Phase
- Phase 1
- 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
- Adult patients, >/= 18 years of age
- Histologically or cytologically documented invasive metastatic breast cancer
- Human epidermal growth factor receptor 2 (HER2) -positive disease
- Adequate bone marrow and organ function (other than hepatic dysfunction allowed by protocol)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Left ventricular ejection fraction >/=50%
- Normal hepatic function, or mild to moderate hepatic impairment (Child-Pugh Class A or B)
Who cannot join
- History of Grade >/=3 infusion reaction, hypersensitivity reaction, or pneumonitis in response to trastuzumab
- Investigational therapy or any other anticancer therapy </=28 days before first study treatment
- Previous treatment with trastuzumab emtansine
- Brain metastases that are untreated or symptomatic or require therapy to control symptoms or any radiation, surgery or other therapy to control symptoms from brain metastases within 1 month of the first study treatment
- History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with a similar outcome as those mentioned above
- Current peripheral neuropathy of Grade >/=2
Show all 16Show fewer
- Child-Pugh Class C hepatic impairment
- Encephalopathy >/= Grade 2
- For patients with normal hepatic function: history of drug or alcohol addiction or history of hepatitis B and/or hepatitis C
- Active hepatitis A, B and/or C
- Current unstable ventricular arrhythmia requiring treatment
- History of symptomatic CHF (NYHA Classes II-IV)
- History of myocardial infarction or unstable angina within 6 months of enrollment
- History of a decrease in LVEF to<40% or symptomatic CHF with previous trastuzumab treatment
- Pregnant or lactating women
- Known HIV infection
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
United States4 sites
Study site
Detroit, Michigan, 48201
Study site
Fort Myers, Florida, 33905
Study site
Nashville, Tennessee, 37203
Study site
Portland, Oregon, 97239
France3 sites
Study site
Marseille, 13273
Study site
Paris, 75231
Study site
Toulouse, 31059
Canada2 sites
Study site
Ottawa, Ontario, K1H8L6
Study site
Toronto, Ontario, M5G 2M9
Italy2 sites
Study site
Catanzaro, Calabria, 88100
Study site
Udine, Friuli Venezia Giulia, 33100
Spain2 sites
Study site
Barcelona, Barcelona, 08003
Study site
Madrid, Madrid, 28007
About this study
Official title: A Phase I, Open Label, Parallel Group, Pharmacokinetic Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function
This open-label, parallel group study will evaluate the pharmacokinetics and safety of trastuzumab emtansine in patients with HER2-positive metastatic breast cancer and normal or reduced hepatic function. Patients will receive trastuzumab emtansine intravenously on Day 1 of each 3-week cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
- Conditions
- Breast Cancer
- Being tested
- trastuzumab emtansine
- 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 emtansineDrug
Multiple intravenous doses
| Study group | Role | What they receive |
|---|---|---|
| Mild hepatic dysfunction | Experimental | Not described Receives: Drug: trastuzumab emtansine |
| Moderate hepatic dysfunction | Experimental | Not described Receives: Drug: trastuzumab emtansine |
| Normal hepatic function | Experimental | Not described Receives: Drug: trastuzumab emtansine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Area under the concentration-time curve
Measured: Multiple sampling pre- and up to 21 days post-dose Cycles 1-3
Secondary outcomes (1)
Safety: Incidence of adverse events in patients with mild or moderate hepatic impairment as compared to patients with normal hepatic function
Measured: approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513083
- Sponsor's protocol ID
- BO25499
- Other IDs
- 2011-004591-10
- Status last verified
- Nov 2016
- First submitted
- 16 Jan 2012
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Parallel Group, Pharmacokinetic Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function
- ClinicalTrials.gov ID
- NCT01513083
- Acronym / sponsor ID
- BO25499
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 20 Jan 2012 (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 open-label, parallel group study will evaluate the pharmacokinetics and safety of trastuzumab emtansine in patients with HER2-positive metastatic breast cancer and normal or reduced hepatic function. Patients will receive trastuzumab emtansine intravenously on Day 1 of each 3-week cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild hepatic dysfunction | Experimental | Drug: trastuzumab emtansine |
| Moderate hepatic dysfunction | Experimental | Drug: trastuzumab emtansine |
| Normal hepatic function | Experimental | Drug: trastuzumab emtansine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients, >/= 18 years of age
- Histologically or cytologically documented invasive metastatic breast cancer
- Human epidermal growth factor receptor 2 (HER2) -positive disease
- Adequate bone marrow and organ function (other than hepatic dysfunction allowed by protocol)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Key exclusion criteria (16 listed)
- History of Grade >/=3 infusion reaction, hypersensitivity reaction, or pneumonitis in response to trastuzumab
- Investigational therapy or any other anticancer therapy </=28 days before first study treatment
- Previous treatment with trastuzumab emtansine
- Brain metastases that are untreated or symptomatic or require therapy to control symptoms or any radiation, surgery or other therapy to control symptoms from brain metastases within 1 month of the first study treatment
- History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with a similar outcome as those mentioned above
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 emtansineMultiple intravenous doses | Drug | Mild hepatic dysfunction, Moderate hepatic dysfunction, Normal hepatic function |
Primary outcome
Pharmacokinetics: Area under the concentration-time curve
Time frame: Multiple sampling pre- and up to 21 days post-dose Cycles 1-3
1 secondary outcome
Safety: Incidence of adverse events in patients with mild or moderate hepatic impairment as compared to patients with normal hepatic function
Time frame: approximately 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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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
Hoffmann-La Roche
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing trastuzumab emtansine in people with Breast Cancer, run by Hoffmann-La Roche at 13 sites in 5 countries.
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 7 inclusion and 16 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: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, France, Canada, Italy, Spain. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Pharmacokinetics: Area under the concentration-time curve (time frame: Multiple sampling pre- and up to 21 days post-dose Cycles 1-3). It is what the study was designed to measure, not a finding.
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 2 Nov 2016.