patients with HER2-positive metastatic cancer who enrolled in a trastuzumab emtansine Genentech/Roche-sponsored study and have received either trastuzumab emtansine as part of the study or have received control arm treatment with the option to receive trastuzumab emtansine according to the parent study protocol, and who either have completed the required parent study assessments or continue to receive study treatment at the time of the parent study closure without evidence of disease progression
Conditions
Interventions
investigational material(s)
Generic name etc : Trastuzumab Emtansine
INN of investigational material : trastuzumab emtansine
Therapeutic category code : 429 Other antitumor agents
Dosage and Administr
Sponsors
CHUGAI PHARMACEUTICAL CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Completed single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment in the parent study or who continue to receive single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment at the time of the parent study closure and received the last study drug dose within the 6 weeks (42 days) prior to the first dose of study therapy on the extension study -Expectation by the investigator that the patient may continue to benefit from additional single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment
Exclusion criteria
Exclusion criteria: -AE(s) leading to single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment discontinuation in the parent study - Ongoing SAE(s) from the parent study - PD (except for isolated brain metastases under certain conditions) on single-agent trastuzumab emtansine or a trastuzumab emtansine-containing regimen during the parent study or before starting the extension study, with the exception of patients from Study TDM4688g with early PD who went on to receive pertuzumab + trastuzumab emtansine treatment and have not experienced further disease progression on the combination regimen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety - Incidence of all AEs and SAEs - Incidence of AEs leading to trastuzumab emtansine or combination trastuzumab emtansine treatment discontinuation or dose reduction | — |
Outcome results
None listed