Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: TX05: All participants will receive treatment with single agent Herceptin or TX05 for up to 10 treatment cycles. Subjects fulfilling the eligibility criteria for this extension study wi
and
(2) subjects originally assigned to Herceptin in the neoadjuvant study will be randomized (1:1) to receive either Herceptin or TX05.
Control Intervention1: Herceptin (Roche): All participants wil
and (2) subjects originally assigned to Herceptin in the neoadjuvant study will be randomized (1:1) to receive either Herceptin or TX05.
Sponsors
Tanvex Biologics Corp
Eligibility
Inclusion criteria
Inclusion 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 local assessment) and no other adjuvant therapy, other than trastuzumab, is planned. However, subjects will be allowed to receive hormonal therapy if they have hormone receptor positive tumors. Subjects will also be allowed to receive adjuvant radiation therapy, if required by their treating physician. 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: - Breast cancer metastases or residual disease postoperatively. - Lactating or pregnant female. - Women of childbearing potential who do not consent to use highly effective methods of birth control - Any condition that in the opinion of the Investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for subjects. - History or presence of a medical condition or disease that in the investigator opinion would place the subject at an unacceptable risk for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To collect safety, tolerability, and immunogenicity data for single agent Herceptin or TX05 in the adjuvant setting in subjects with early human epidermal growth factor receptor (HER2)-positive breast cancer who completed neoadjuvant treatment and primary resection in Protocol TX05-03. ââ?¬Â¢ To collect safety, tolerability, and immunogenicity data following a single transition from neoadjuvant Herceptin to adjuvant TX05 in this population. Timepoint: To collect safety, tolerability, and immunogenicity data for single agent Herceptin or TX05 in the adjuvant setting in subjects with early human epidermal growth factor receptor (HER2)-positive breast cancer who completed neoadjuvant treatment and primary resection in Protocol TX05-03. ââ?¬Â¢ To collect safety, tolerability, and immunogenicity data following a single transition from neoadjuvant Herceptin to adjuvant TX05 in this population. End of Study (EOS) Visit at Week 36 (Ã?± 7 days). | — |
Secondary
| Measure | Time frame |
|---|---|
| To collect disease-free survival (DFS) and overall survival (OS) data in this populationTimepoint: 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. | — |
Countries
Belarus, Brazil, Bulgaria, Chile, Georgia, Hungary, India, Italy, Mexico, Peru, Philippines, Poland, Republic of Korea, Romania, Russian Federation, Slovakia, Thailand, Ukraine
Contacts
Public ContactDr Gursimran Kaur
JSS Medical Research India Private Limited
Outcome results
None listed