HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast CancerPhase 4NCT02658734
A Study of Trastuzumab Emtansine in Indian Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Treatment With Trastuzumab and a Taxane
A Phase 4 study testing Trastuzumab emtansine in people with HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer, run by Hoffmann-La Roche at 13 sites in India.
Trial summary
This is a Phase IV, single-arm, multicenter, open-label clinical trial designed to assess the safety of trastuzumab emtansine in Indian patients with HER2-positive unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior treatment with trastuzumab and a taxane. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced 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
- 70 participants
- Where
- 13 sitesIndia
- Study dates
- 1 Nov 2016to 14 Dec 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Prospectively confirmed HER2-positive (i.e., IHC 3+ or IHC 2+ and gene amplified by fluorescence in situ hybridization [FISH] positive) as assessed on primary tumor and/or metastatic site
- Documented progression of unresectable, locally advanced, or mBC, determined by the investigator
- Left ventricular ejection fraction (LVEF) >/= 50% by echocardiogram (ECHO)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- A negative serum Beta-Human Chorionic Gonadotropin (Beta-HCG) test for women of childbearing potential (premenopausal or not meeting the definition of postmenopausal i.e. >/= 12 months of amenorrhea), and women who have not undergone surgical sterilization (i.e., absence of ovaries and/or uterus)
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use two adequate non-hormonal methods of contraception, including at least one method with a failure rate of <1% per year, during the treatment period and for at least 7 months after the last dose of study drug
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm. With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of <1% per year during the treatment period and for at least 7 months plus 90 days (a spermatogenesis cycle) after the last dose of study drug. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 7 months after the last dose of study drug.
Who cannot join
- Prior treatment with trastuzumab emtansine
- Prior treatment with lapatinib or lapatinib with capecitabine or non-comparable biologic or biosimilar of trastuzumab
- Peripheral neuropathy of Grade >/= 3 per the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE [version 4.03])
- History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive breast cancer, or cancers with a similar curative outcome as those mentioned above
- History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to enrollment except hormone therapy, which can be given up to 7 days prior to enrollment; recovery of treatment-related toxicity consistent with other eligibility criteria
- History of exposure to cumulative doses of anthracyclines, as defined in the protocol
Show all 19Show fewer
- History of radiation therapy within 14 days of enrollment
- Brain metastases that are untreated, symptomatic, or require therapy to control symptoms, as well as a history of radiation, surgery, or other therapy, including steroids, to control symptoms from brain metastases within 2 months (60 days) before enrollment
- CNS only disease
- History of a decrease in LVEF to < 40% or symptomatic congestive heart failure (CHF) with previous trastuzumab treatment
- History of symptomatic chronic heart failure (New York Heart Association [NYHA] Classes II-IV) or serious cardiac arrhythmia requiring treatment
- History of myocardial infarction or unstable angina within 6 months of enrollment
- Current dyspnea at rest due to complications of advanced malignancy or requirement for continuous oxygen therapy
- Current severe, uncontrolled systemic disease
- Pregnancy or lactation
- Concurrent, serious, uncontrolled infections or current known infection with human immunodeficiency virus (HIV) or active hepatitis B and/or hepatitis C. For patients who are known carriers of hepatitis B virus (HBV), active hepatitis B infection must be ruled out, based on negative serologic testing and/or determination of HBV DNA viral load per local guidelines
- Presence of conditions that could affect gastrointestinal absorption: malabsorption syndrome, resection of the small bowel or stomach, and ulcerative colitis
- History of intolerance (such as Grade 3-4 infusion reaction) or known hypersensitivity to trastuzumab or murine proteins or any component of the product
- Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
India13 sites
Manipal Hospital; Department of Oncology
Bangalore, Karnataka, 560017
Healthcare Global Enterprises Limited
Bangalore, 560027
Apollo Hospitals International Limited
Gandhinagar, Gujarat, 382428
Artemis Health Institute
Gūrgaon, 122001
Fortis Memorial Research Institute; Department of Medical Oncology & Haematology
Gūrgaon, 122002
Tata Memorial Hospital; Dept of Medical Oncology
Mumbai, Maharashtra, 400012
Indraprastha Apollo Hospitals
New Delhi, National Capital Territory of Delhi, 110076
Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology
New Delhi, National Capital Territory of Delhi, 110085
Sir Gangaram Hospital; Medical Oncology
New Delhi, 110 060
Max Super Speciality Hospital
New Delhi, 110017
Max Super Speciality Hospital; Medical Oncology
North WEST Delhi, National Capital Territory of Delhi, 110088
Jehangir Hospital
Pune, Maharashtra, 411001
Christian Medical College & Hospital; Medicine
Vellore, Tamil Nadu, 632004
About this study
Official title: A Multicenter, Open-Label, Single-Arm, Phase IV Study of Trastuzumab Emtansine in Indian Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Treatment With Trastuzumab and a Taxane
This is a Phase IV, single-arm, multicenter, open-label clinical trial designed to assess the safety of trastuzumab emtansine in Indian patients with HER2-positive unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior treatment with trastuzumab and a taxane.
- 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
3.6 mg/kg intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle, repeated every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Trastuzumab emtansine | Experimental | Not described Receives: Drug: Trastuzumab emtansine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Adverse Events
Adverse events (AEs) grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
Measured: From cycle 1 up to approximately 3 years
Percentage of Participants With Adverse Events
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with the treatment. An adverse event was therefore any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsened during the study were also considered as adverse events.
Measured: From cycle 1 up to approximately 3 years
Secondary outcomes (14)
Percentage of Participants With Serious Adverse Events (SAEs)
SAEs were defined as any AE that fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/ birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.
Measured: From cycle 1 up to approximately 3 years
Severity of SAEs as Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03
Severity refered to the intensity of an AE (e.g., rated as mild, moderate, or severe, or according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria.
Measured: From cycle 1 up to approximately 3 years
Percentage of Participants With Non-Serious Adverse Events of Special Interest
Non-serious AEs of special interest included cases of severe drug-induced liver injury and suspected transmission of an infectious agent by the study drug.
Measured: From cycle 1 up to approximately 3 years
Laboratory Results Abnormalities
Measured: From cycle 1 up to approximately 3 years
Percentage of Participants With Adverse Events Leading to Discontinuation of Study Medication
Measured: From cycle 1 up to approximately 3 years
Percentage of Participants With Adverse Events Leading to Modification of Study Medication
Measured: From cycle 1 up to approximately 3 years
Percentage of Participants With Adverse Events Leading to Interruption of Study Medication
Measured: From cycle 1 up to approximately 3 years
Exposure to Study Drug
Exposure to study drug was the amount of study drug received over time (weeks).
Measured: From cycle 1 up to approximately 3 years
Percentage of Participants With Drug-Induced Liver Injury Meeting Hy's Law Criteria
Hy's law criteria for potential drug-induced liver injury included elevated aminotransferase enzymes (ALT/AST) with concurrent elevated serum total bilirubin, gross jaundice, clinical disability and the need for hospital care.
Measured: From cycle 1 up to approximately 3 years
Percentage of Participants With Congestive Heart Failure
Measured: From cycle 1 up to approximately 3 years
Change in Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram
Measured: From baseline to every three cycles of treatment up to Cycle 39 Day 1, and at the 2-days post-treatment, safety follow-up visits 1 and 3
Overall Response Rate (ORR)
ORR was based on the best (confirmed) overall response (BOR). ORR was defined as the number (%) of participants with confirmed complete response (CR) or partial response (PR) where the confirmation was performed no less than 4 weeks after the criteria for response were first met.
Measured: From cycle 1 up to approximately 3 years
Progression-Free Survival (PFS)
PFS was defined as the time from the date of enrollment until the date of first documented progression of disease or the date of death (by any cause in the absence of progression) whichever occurred first.
Measured: From cycle 1 up to approximately 3 years
Overall Survival (OS)
Overall survival was defined as the time from the date of enrollment until the date of death due to any cause. Participants not known to have died at the time of final analysis were censored based on the last recorded date on which the subject was known to be alive.
Measured: From cycle 1 up to approximately 3 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 2016 (estimated)
- Study start1 Nov 2016
- Primary completion14 Dec 2019
- Study completion14 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced 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 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 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
- NCT02658734
- Sponsor's protocol ID
- ML29662
- Status last verified
- Mar 2021
- First submitted
- 15 Jan 2016
- Last updated
- 2 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Single-Arm, Phase IV Study of Trastuzumab Emtansine in Indian Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Treatment With Trastuzumab and a Taxane
- ClinicalTrials.gov ID
- NCT02658734
- Acronym / sponsor ID
- ML29662
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 14 Dec 2019 (actual)
- Study completion
- 14 Dec 2019 (actual)
- First posted
- 20 Jan 2016 (estimated)
- Results
- Posted 9 Feb 2021
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 Phase IV, single-arm, multicenter, open-label clinical trial designed to assess the safety of trastuzumab emtansine in Indian patients with HER2-positive unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior treatment with trastuzumab and a taxane.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trastuzumab emtansine | 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)
- Prospectively confirmed HER2-positive (i.e., IHC 3+ or IHC 2+ and gene amplified by fluorescence in situ hybridization [FISH] positive) as assessed on primary tumor and/or metastatic site
- Documented progression of unresectable, locally advanced, or mBC, determined by the investigator
- Left ventricular ejection fraction (LVEF) >/= 50% by echocardiogram (ECHO)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- A negative serum Beta-Human Chorionic Gonadotropin (Beta-HCG) test for women of childbearing potential (premenopausal or not meeting the definition of postmenopausal i.e. >/= 12 months of amenorrhea), and women who have not undergone surgical sterilization (i.e., absence of ovaries and/or uterus)
Key exclusion criteria (19 listed)
- Prior treatment with trastuzumab emtansine
- Prior treatment with lapatinib or lapatinib with capecitabine or non-comparable biologic or biosimilar of trastuzumab
- Peripheral neuropathy of Grade >/= 3 per the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE [version 4.03])
- History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive breast cancer, or cancers with a similar curative outcome as those mentioned above
- History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to enrollment except hormone therapy, which can be given up to 7 days prior to enrollment; recovery of treatment-related toxicity consistent with other eligibility criteria
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 emtansine3.6 mg/kg intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle, repeated every 3 weeks | Drug | Trastuzumab emtansine |
Primary outcome
Severity of Adverse Events
Time frame: From cycle 1 up to approximately 3 years
Adverse events (AEs) grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
Percentage of Participants With Adverse Events
Time frame: From cycle 1 up to approximately 3 years
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with the treatment. An adverse event was therefore any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsened during the study were also considered as adverse events.
14 secondary outcomes
Percentage of Participants With Serious Adverse Events (SAEs)
Time frame: From cycle 1 up to approximately 3 years
Severity of SAEs as Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03
Time frame: From cycle 1 up to approximately 3 years
Percentage of Participants With Non-Serious Adverse Events of Special Interest
Time frame: From cycle 1 up to approximately 3 years
Laboratory Results Abnormalities
Time frame: From cycle 1 up to approximately 3 years
Percentage of Participants With Adverse Events Leading to Discontinuation of Study Medication
Time frame: From cycle 1 up to approximately 3 years
Percentage of Participants With Adverse Events Leading to Modification of Study Medication
Time frame: From cycle 1 up to approximately 3 years
Percentage of Participants With Adverse Events Leading to Interruption of Study Medication
Time frame: From cycle 1 up to approximately 3 years
Exposure to Study Drug
Time frame: From cycle 1 up to approximately 3 years
Percentage of Participants With Drug-Induced Liver Injury Meeting Hy's Law Criteria
Time frame: From cycle 1 up to approximately 3 years
Percentage of Participants With Congestive Heart Failure
Time frame: From cycle 1 up to approximately 3 years
Change in Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram
Time frame: From baseline to every three cycles of treatment up to Cycle 39 Day 1, and at the 2-days post-treatment, safety follow-up visits 1 and 3
Overall Response Rate (ORR)
Time frame: From cycle 1 up to approximately 3 years
Progression-Free Survival (PFS)
Time frame: From cycle 1 up to approximately 3 years
Overall Survival (OS)
Time frame: From cycle 1 up to approximately 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trastuzumab emtansine in people with HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer, run by Hoffmann-La Roche at 13 sites in India.
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 19 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 Apr 2021. 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 India. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Severity of Adverse Events (time frame: From cycle 1 up to approximately 3 years). The study lists 2 primary outcomes in all. 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 Apr 2021.