An Open-Label, Multicenter Extension Study of Trastuzumab-MCC-DM1 (T-DM1) Administered as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients Previously Treated With the Equivalent T-DM1 Regimen in a Genentech and/or F. Hoffmann-La Roche Ltd.-Sponsored T-DM1 Study
This is a global, multicenter, open-label extension study. Patients receiving single-agent T-DM1 or combination T-DM1 administered in combination with paclitaxel or with pertuzumab ± paclitaxel in a Genentech/Roche-sponsored study who completed the parent study or who continue to receive study drug(s) at the time of the parent study closure are eligible for continued treatment on this protocol.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : paclitaxel
- drug : docetaxel
- drug : trastuzumab [Herceptin]
- drug : pertuzumab [Perjeta]
- drug : trastuzumab emtansine [Kadcyla]
Phase: Phase 2
Ages Eligible For Study:
- 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 scheduled dose of study therapy on the extension study or Continue to receive treatment in the control arm of Study TDM4450g at the time of the parent study closure if the patient received the last dose of control arm study drug within the 6 weeks (42 days) prior to the first scheduled dose of control arm study therapy in the extension study - Patients in the control arm from Study TDM4450g whose disease progression has occurred during the transition interval between the parent study and this extension study may initiate trastuzumab emtansine treatment at the time of enrollment into Study TDM4529g - Expectation by the investigator that the patient may continue to benefit from additional single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment or Expectation of the investigator that the patient may continue to benefit from control arm treatment as given in Study TDM4450g and at the time of disease progression may benefit from single-agent trastuzumab emtansine treatment - Patients from parent study BO25499 must be on a stable dose of trastuzumab emtansine for at least two cycles - Women of childbearing potential and men with partners of childbearing potential, must be willing to use a highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception by the patient and/or partner, and to continue the use of contraception for the duration of study treatment and for at least 6 months after the last dose of study treatment - Male patients whose partners are pregnant should use condoms for the duration of the pregnancy