None listed
Conditions
Interventions
TX05 Type of group
IV TX05 8 mg/kg loading dose then 6 mg/kg every 3 weeks for 10 cycles.
Group name:Herceptin Type of group
IV Herceptin 8 mg/kg loading dose then 6 mg/kg every 3 weeks for 10 cycles.
Sponsors
Tanvex Biologics Corporation,
Eligibility
Inclusion criteria
Inclusion criteria: Subjects eligible for enrollment in the study must meet all of the following criteria: 1. Signed written informed consent. 2. Females ≥ 18 years of age. 3. Completed neoadjuvant treatment (regardless of treatment arm) in the TX05/ Herceptin neoadjuvant study and the investigator believes the subject requires continued access to single agent trastuzumab in order to continue deriving clinical benefit. 4. Successfully undergone surgical resection of their primary tumor with no evidence of residual disease, as determined by central review and no other adjuvant therapy, other than trastuzumab, is planned. 5. Able to comply with the study protocol. 6. Female subjects of childbearing potential must have a negative serum pregnancy test within 14 days of first administration of study drug and agree to use effective contraception (hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide) throughout the study period and for 7 months after last administration of study drug.
Exclusion criteria
Exclusion criteria: 1. Breast cancer metastases or residual disease post operatively. 2. History or presence of a medical condition or disease that in the investigator´s opinion would place the subject at an unacceptable risk for study participation. 3. Lactating or pregnant female. 4. Women of childbearing potential who do not consent to use highly effective methods of birth control (e.g. true abstinence [periodic abstinence {e.g. calendar ovulation, symptothermal, post-ovulation methods} and withdrawal are not acceptable methods of contraception], sterilization, or other non-hormonal forms of contraception) during treatment and for at least 7 months after the last administration of study drug. Subjects must agree to not breast-feed while receiving study drug. 5. Any condition that in the opinion of the Investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:•TEAEs and SAEs. •Death. •Clinical laboratory parameters. •Vital signs. •12-lead ECG. •LVEF. •Physical examination. In general, continuous variables will be summarized using the following standard descriptive summary statistics: number of observations, arithmetic mean, standard deviation, minimum, median, and maximum. Categorical variables will be displayed by means of frequency tables including percentages. The safety population will include all subjects who are randomized into this extension study and have received at least one dose of study drug. The safety population will be used for all analyses. •Incidence of ADA. •Incidence of Nab. Measure:Safety Endpoints Immunogenicity Endpoints Timepoints:NA | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The time to event endpoints (DFS and OS) will be summarized using Kaplan-Meier survival curves. The Kaplan-Meier survival estimates, together with the number of subjects, percentage of subjects to experience the event, and the number and percentage of subjects censored will be summarized in a table by treatment group. No interim analysis is planned. Measure:Efficacy Endpoints: • DFS, defined as the time from randomization in the neoadjuvant study (Protocol TX05 03) to the documentation of a first failure, where a failure is the recurrence of breast cancer or a diagnosis of a second primary cancer. • OS, defined as the time from randomization in the neoadjuvant study (Protocol TX05-03) until death from any cause. Timepoints:Until the documentation of a first failure, where a failure is the recurrence of breast cancer or a diagnosis of a second primary cancer. ; Outcome name:The time to event endpoints (DFS and OS) will be summarized using Kaplan-Meier survival curves. The Kaplan-Meier survival estimates, together with the number of subjects, percentage of subjects to experience the event, and the number and percentage of subjects censored will be summarized in a table by treatment group. No interim analysis is planned. Measure:Efficacy Endpoints: • DFS, defined as the time from randomization in the neoadjuvant study (Protocol TX05 03) to the documentation of a first failure, where a failure is the recurrence of breast cancer or a diagnosis of a second primary cancer. • OS, defined as the time from randomization in the neoadjuvant study (Protocol TX05-03) until death from any cause. Timepoints:Until the documentation of a first failure, where a failure is the recurrence of breast cancer or a diagnosis of a second primary cancer. | — |
Countries
Brazil, Bulgaria, Chile, Georgia, Hungary, India, Italy, Korea South, Peru, Philippines, Poland, Romania, Russian Federation, Slovakia, Spain, Thailand, Turkey, Ukraine
Contacts
Public ContactElizabeth Ayala
ICON CLINICAL RESEARCH PERU S.A.
Outcome results
None listed