Trial Search Results

A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies

This is a global, multicenter, open-label safety extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other agents in a Genentech/Roche-sponsored parent study who are active and deriving benefit at the closure of parent study are eligible for continued treatment in this study.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Genentech, Inc.

Collaborator: Hoffmann-La Roche

Stanford Investigator(s):


  • Drug: Docetaxel
  • Drug: Paclitaxel
  • Drug: Pertuzumab
  • Drug: Trastuzumab
  • Drug: Trastuzumab Emtansine


Phase 2


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 or Continue to receive
   treatment in the control arm of study BO21976/TDM4450g (NCT00679341) at the time of
   the parent study closure if the participant received the last dose of control arm
   study drug within the 6 weeks (42 days) prior to the first dose of control arm study
   therapy in the extension study

   - Participants in the control arm from Study BO21976/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 (NCT00781612)

   - Expectation by the investigator that the participant may continue to benefit from
   additional single-agent trastuzumab emtansine or combination trastuzumab emtansine
   treatment or Expectation of the investigator that the participant may continue to
   benefit from control arm treatment as given in study BO21976/TDM4450g and at the time
   of disease progression may benefit from single-agent trastuzumab emtansine treatment

   - 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 participants and/or partner, and
   to continue the use of contraception for the duration of study treatment and for at
   least 7 months after the last dose of study treatment

   - Male participants whose partners are pregnant should use condoms for the duration of
   the pregnancy

Exclusion Criteria:

   - AEs leading to single-agent trastuzumab emtansine or combination trastuzumab emtansine
   treatment discontinuation in the parent study

   - Ongoing SAEs from the parent study

   - Progressive disease 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 participants from study TDM4688g (NCT00943670) with early
   disease progression who went on to receive pertuzumab + trastuzumab emtansine
   treatment and have not experienced further disease progression on the combination

   - Peripheral neuropathy of Grade greater than or equal to (>/=) 3 per the National
   Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version
   3.0 or 4.0, as utilized in the parent study

   - History of symptomatic congestive heart failure ([CHF]; New York Heart Association
   [NYHA] Classes II-IV), ventricular arrhythmia requiring treatment, current unstable
   angina, or history of myocardial infarction within 6 months prior to study entry

   - Severe dyspnea at rest due to complications of advanced malignancy or current
   requirement for continuous oxygen therapy

   - Current severe, uncontrolled systemic disease (for example [e.g.] clinically
   significant cardiovascular, pulmonary, or metabolic disease)

   - Major surgical procedure or significant traumatic injury within 28 days prior to study
   entry or anticipation of the need for major surgery during the course of study

   - Current pregnancy or lactation

   - History of receiving any investigational treatment or other systemic therapy directed
   at controlling cancer (e.g., chemotherapy, trastuzumab, etc.) since the participant's
   last study drug dose in the parent study

   - History of hypersensitivity with previous trastuzumab emtansine or any agent used with
   trastuzumab emtansine in the parent study, precluding further dosing

   - Assessed by the investigator to be unable or unwilling to comply with the requirements
   of the protocol

Ages Eligible for Study

N/A - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting