A Phase 3 interventional study of Trastuzumab Emtansine in Breast Cancer, sponsored by Hoffmann-La Roche. Completed at 300 sites in 43 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-04.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general participant population; Cohort 2 will include only Asian participants.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 2,185 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This cohort will enroll all participants with HER2-positive, unresectable, LABC or mBC who have received prior anti-HER2 and chemotherapy treatment and have progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants will receive trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
Drug: Trastuzumab Emtansine
This cohort will enroll Asian race participants with HER2-positive, unresectable, LABC or mBC who have received prior anti-HER2 and chemotherapy treatment and have progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants will receive trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
Drug: Trastuzumab Emtansine
Participants will receive trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenously on Day 1 of a 3-week cycle every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
Also known as: RO5304020, T-DM1, Kadcyla
Percentage of Participants With Adverse Events of Primary Interest (AEPIs)
The AEPIs in this study were defined as the following: adverse events (AEs) Grade \>/= 3, specifically, hepatic events, allergic reactions, thrombocytopenia and hemorrhage events, all Grade \>/= 3 AEs related to trastuzumab emtansine and pneumonitis events of all grades.
Time frame: Baseline up to approximately 7 years
Percentage of Participants With Specific AEPIs
The AEPIs in this study were defined as the following: adverse events (AEs) Grade \>/= 3, specifically, hepatic events, allergic reactions, thrombocytopenia and hemorrhage events, all Grade \>/= 3 AEs related to trastuzumab emtansine and pneumonitis events of all grades.
Time frame: Baseline up to approximately 7 years
Percentage of Participants With Adverse Events of Special Interest (AESIs)
AESIs included: 1) Potential drug-induced liver injury, which included any potential case of drug-induced liver injury as, assessed by laboratory criteria for Hy's law (AST and/or ALT elevations that were \>3 × ULN, Concurrent elevation of total bilirubin \>2 × ULN (or clinical jaundice if total bilirubin measures were not available), except in participants with documented Gilbert's syndrome. Those with Gilbert's syndrome, elevation of direct bilirubin \>2 × ULN was used instead. 2) Suspected transmission of an infectious agent by study drug was defined as any organism, virus, or infectious particle (e.g., prion protein transmitting transmissible spongiform encephalopathy), pathogenic or non-pathogenic. A transmission of an infectious agent suspected from clinical symptoms or laboratory findings indicating an infection in a participant exposed to a medicinal product.
Time frame: Baseline up to approximately 7 years
Progression-Free Survival According to Response Evaluation for Solid Tumors (RECIST) Version (v) 1.1 As Per Investigator Assessment
Progression free survival is defined as the time (in months) between the date of first dose and the date of disease progression or death from any cause. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Time frame: Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
Overall Survival
Overall survival is defined as time to death, which is the time from the date of dosing until the date of death, regardless of the cause of death.
Time frame: Baseline until death (up to approximately 7 years)
Percentage of Participants With Best Overall Response (Complete Response [CR] or Partial Response [PR]) According to RECIST v 1.1 As Per Investigator Assessment
Best Overall Response reported here is the Best confirmed Overall Response. To be assigned a status of PR or CR, i.e., to be a responder, changes in tumor measurements had to be confirmed by repeat assessments that had to be performed no less than 4 weeks after the criteria for response were first met, i.e., participants needed to have two consecutive assessments of PR or CR. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
Time frame: Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
Percentage of Participants With Clinical Benefit (CR or PR or Stable Disease [SD]) According to RECIST v 1.1
Clinical Benefit was defined as CR plus PR plus SD. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD: neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD.
Time frame: Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
Duration of Response (DOR) According to RECIST v 1.1
DOR is defined as the period from the date of initial confirmed PR or CR (whichever occurs first) until the date of PD or death from any cause. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Time frame: Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
Time to Response According to RECIST v 1.1
Time to Response is defined as the time from first dose to first documentation of confirmed PR or CR (whichever occurs first). CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
Time frame: Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
Number of Hospital Visits
The number of hospital visits were recorded to evaluate the resoruce expenditures while participants were on study treatment.
Time frame: Baseline up to approximately 7 years
Type of Hospital Visits
The type of hospital visits (intensive care unit (ICU) versus other) were recorded to evaluate the resoruce expenditures while participants were on study treatment. The number of participants with at least one ICU visit are based on the number of participants with at least one hospital visit, in each group.
Time frame: Baseline up to approximately 7 years
Cohort 1 has 2003 participants and Cohort 2 has 182 participants representing the total enrollment study number. Cohort 1 was conducted in 281 centers in 40 countries worldwide whereas Cohort 2 was conducted in an Asian population in 14 centers in China, Thailand and Indonesia.
| Milestone | Trastuzumab Emtansine (All Participants) | Trastuzumab Emtansine (Asian Participants) |
|---|---|---|
| Started | 2003 | 182 |
| Completed | 494 | 65 |
| Not completed | 1509 | 117 |
| Withdrew: Death | 1067 | 76 |
| Withdrew: Lost to follow-up | 144 | 10 |
| Withdrew: Adverse event/unacceptable toxicity | 4 | 0 |
| Withdrew: Investigator decision | 5 | 0 |
| Withdrew: Not classifiable | 1 | 0 |
| Withdrew: On study treatment at lplv/cohort 1 | 93 | 0 |
| Withdrew: On study treatment at lplv/cohort 2 | 0 | 1 |
| Withdrew: Progressive disease | 3 | 0 |
| Withdrew: Protocol violation | 2 | 0 |
| Withdrew: Safety fu done < 3 months prior to ccod | 9 | 1 |
| Withdrew: Termination by sponsor | 4 | 0 |
| Withdrew: Withdrawal by subject | 177 | 29 |
The AEPIs in this study were defined as the following: adverse events (AEs) Grade \>/= 3, specifically, hepatic events, allergic reactions, thrombocytopenia and hemorrhage events, all Grade \>/= 3 AEs related to trastuzumab emtansine and pneumonitis events of all grades.
| Percentage of Participants | Trastuzumab Emtansine (All Participants) | Trastuzumab Emtansine (Asian Participants) |
|---|---|---|
| Percentage of Participants With Adverse Events of Primary Interest (AEPIs) | 23.1 (21.2 to 25.0) | 51.4 (43.9 to 58.9) |
The AEPIs in this study were defined as the following: adverse events (AEs) Grade \>/= 3, specifically, hepatic events, allergic reactions, thrombocytopenia and hemorrhage events, all Grade \>/= 3 AEs related to trastuzumab emtansine and pneumonitis events of all grades.
| Percentage of Participants | Trastuzumab Emtansine (All Participants) | Trastuzumab Emtansine (Asian Participants) |
|---|---|---|
| AEs Grade >/= 3 for hepatic events | 6.9 | 12.2 |
| AEs Grade >/= 3 for allergic reactions | 2.3 | 1.1 |
| AEs Grade >/= 3 for thrombocytopenia | 3.7 | 36.5 |
| AEs Grade >/= 3 for hemorrhage events | 2.3 | 1.7 |
| AEs Grade >/= 3 related to trastuzumab emtansine | 18.4 | 48.6 |
| Pneumonitis of all grades | 1.0 | 2.2 |
AESIs included: 1) Potential drug-induced liver injury, which included any potential case of drug-induced liver injury as, assessed by laboratory criteria for Hy's law (AST and/or ALT elevations that were \>3 × ULN, Concurrent elevation of total bilirubin \>2 × ULN (or clinical jaundice if total bilirubin measures were not available), except in participants with documented Gilbert's syndrome. Those with Gilbert's syndrome, elevation of direct bilirubin \>2 × ULN was used instead. 2) Suspected transmission of an infectious agent by study drug was defined as any organism, virus, or infectious particle (e.g., prion protein transmitting transmissible spongiform encephalopathy), pathogenic or non-pathogenic. A transmission of an infectious agent suspected from clinical symptoms or laboratory findings indicating an infection in a participant exposed to a medicinal product.
| Percentage of Participants | Trastuzumab Emtansine (All Participants) | Trastuzumab Emtansine (Asian Participants) |
|---|---|---|
| Potential drug-induced liver injury | 1.2 | 1.1 |
| Suspected transmission of an infectious agent | 0.2 | 0.0 |
Progression free survival is defined as the time (in months) between the date of first dose and the date of disease progression or death from any cause. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
| months | Trastuzumab Emtansine (All Participants) | Trastuzumab Emtansine (Asian Participants) |
|---|---|---|
| Progression-Free Survival According to Response Evaluation for Solid Tumors (RECIST) Version (v) 1.1 As Per Investigator Assessment | 6.8 (5.8 to 7.6) | 5.7 (5.5 to 7.0) |
Overall survival is defined as time to death, which is the time from the date of dosing until the date of death, regardless of the cause of death.
| months | Trastuzumab Emtansine (All Participants) | Trastuzumab Emtansine (Asian Participants) |
|---|---|---|
| Overall Survival | 27.2 (25.5 to 28.7) | 29.5 (21.1 to NA) |
Best Overall Response reported here is the Best confirmed Overall Response. To be assigned a status of PR or CR, i.e., to be a responder, changes in tumor measurements had to be confirmed by repeat assessments that had to be performed no less than 4 weeks after the criteria for response were first met, i.e., participants needed to have two consecutive assessments of PR or CR. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
| Percentage of Participants | Trastuzumab Emtansine (All Participants) | Trastuzumab Emtansine (Asian Participants) |
|---|---|---|
| Percentage of Participants With Best Overall Response (Complete Response [CR] or Partial Response [PR]) According to RECIST v 1.1 As Per Investigator Assessment | 29.3 (27.1 to 31.6) | 29.6 (22.8 to 37.1) |
Clinical Benefit was defined as CR plus PR plus SD. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD: neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD.
| Percentage of Participants | Trastuzumab Emtansine (All Participants) | Trastuzumab Emtansine (Asian Participants) |
|---|---|---|
| Percentage of Participants With Clinical Benefit (CR or PR or Stable Disease [SD]) According to RECIST v 1.1 | 47.1 (44.7 to 49.6) | 39.6 (32.2 to 47.4) |
DOR is defined as the period from the date of initial confirmed PR or CR (whichever occurs first) until the date of PD or death from any cause. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
| months | Trastuzumab Emtansine (All Participants) | Trastuzumab Emtansine (Asian Participants) |
|---|---|---|
| Duration of Response (DOR) According to RECIST v 1.1 | 13.8 (12.2 to 15.0) | 14.2 (11.1 to 24.4) |
Time to Response is defined as the time from first dose to first documentation of confirmed PR or CR (whichever occurs first). CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
| months | Trastuzumab Emtansine (All Participants) | Trastuzumab Emtansine (Asian Participants) |
|---|---|---|
| Time to Response According to RECIST v 1.1 | 22.3 (11.8 to 38.2) | 8.3 (5.7 to NA) |
The number of hospital visits were recorded to evaluate the resoruce expenditures while participants were on study treatment.
| Number of Hospital Visits | Trastuzumab Emtansine (All Participants) | Trastuzumab Emtansine (Asian Participants) |
|---|---|---|
| Number of Hospital Visits | 2.7 ± 2.78 | 2.1 ± 1.70 |
The type of hospital visits (intensive care unit (ICU) versus other) were recorded to evaluate the resoruce expenditures while participants were on study treatment. The number of participants with at least one ICU visit are based on the number of participants with at least one hospital visit, in each group.
| Participants | Trastuzumab Emtansine (All Participants) | Trastuzumab Emtansine (Asian Participants) |
|---|---|---|
| Other Hospital Visit | 558 | 33 |
| ICU Visit | 39 | 0 |
Collected over Baseline up to approximately 7 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Trastuzumab Emtansine (All Participants) | 1,072/2,002 (53.5%) | 427/2,002 (21.3%) | 1,734/2,002 (86.6%) |
| Trastuzumab Emtansine (Asian Participants) | 77/181 (42.5%) | 36/181 (19.9%) | 170/181 (93.9%) |
| Event | Trastuzumab Emtansine (All Participants) | Trastuzumab Emtansine (Asian Participants) |
|---|---|---|
| THROMBOCYTOPENIABlood and lymphatic system disorders | 11/2002 | 10/181 |
| PNEUMONIAInfections and infestations | 22/2002 | 8/181 |
| PLATELET COUNT DECREASEDInvestigations | 2/2002 | 8/181 |
| UPPER GASTROINTESTINAL HAEMORRHAGEGastrointestinal disorders | 3/2002 | 2/181 |
| VOMITINGGastrointestinal disorders | 17/2002 | 1/181 |
| ANAEMIABlood and lymphatic system disorders | 13/2002 | 0/181 |
| PYREXIAGeneral disorders | 13/2002 | 0/181 |
| ACUTE CORONARY SYNDROMECardiac disorders | 3/2002 | 1/181 |
| PALPITATIONSCardiac disorders | 1/2002 | 1/181 |
| CATARACTEye disorders | 0/2002 | 1/181 |
| Event | Trastuzumab Emtansine (All Participants) | Trastuzumab Emtansine (Asian Participants) |
|---|---|---|
| ASPARTATE AMINOTRANSFERASE INCREASEDInvestigations | 136/2002 | 77/181 |
| NAUSEAGastrointestinal disorders | 651/2002 | 28/181 |
| ALANINE AMINOTRANSFERASE INCREASEDInvestigations | 86/2002 | 58/181 |
| PLATELET COUNT DECREASEDInvestigations | 91/2002 | 55/181 |
| FATIGUEGeneral disorders | 556/2002 | 12/181 |
| THROMBOCYTOPENIABlood and lymphatic system disorders | 165/2002 | 47/181 |
| PYREXIAGeneral disorders | 339/2002 | 47/181 |
| ASTHENIAGeneral disorders | 491/2002 | 18/181 |
| HEADACHENervous system disorders | 454/2002 | 19/181 |
| EPISTAXISRespiratory, thoracic and mediastinal disorders | 402/2002 | 30/181 |
| Age, Continuous(Years) | Trastuzumab Emtansine (All Participants) | Trastuzumab Emtansine (Asian Participants) | Total |
|---|---|---|---|
| Mean | 54.5 ± 11.4 | 49.1 ± 10.1 | 54.1 ± 11.4 |
| Sex: Female, Male(Participants) | Trastuzumab Emtansine (All Participants) | Trastuzumab Emtansine (Asian Participants) | Total |
|---|---|---|---|
| Female | 1989 | 182 | 2171 |
| Male | 14 | 0 | 14 |
| Race/Ethnicity, Customized(Participants) | Trastuzumab Emtansine (All Participants) | Trastuzumab Emtansine (Asian Participants) | Total |
|---|---|---|---|
| Caucasian | 1397 | 0 | 1397 |
| Black | 21 | 0 | 21 |
| Asian | 72 | 182 | 254 |
| Native American | 41 | 0 | 41 |
| N/A as per local regulation | 466 | 0 | 466 |
| Unknown | 3 | 0 | 3 |
| Other | 2 | 0 | 2 |
| Missing | 1 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | Trastuzumab Emtansine (All Participants) | Trastuzumab Emtansine (Asian Participants) | Total |
|---|---|---|---|
| Hispanic/Latino | 300 | 0 | 300 |
| Chinese | 29 | 147 | 176 |
| N/A as per local regulation | 997 | 16 | 1013 |
| Other | 417 | 19 | 436 |
| Mixed | 9 | 0 | 9 |
| Indian (Indian subcontinent) | 4 | 0 | 4 |
| Unknown | 247 | 0 | 247 |
Showing the first 100 of 300 sites across 43 countries. Choose a country and city above to see the rest.
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Studies of the drug tested here: Ado-Trastuzumab Emtansine