HER-2 positive breast cancer MedDRA version: 20.0 Level: PT Classification code 10065430 Term: HER-2 positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: TX05
Product Code: TX05
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: TRASTUZUMAB
CAS Number: 180288-69-1
Concentration unit: mg/ml milligram
Sponsors
Tanvex Biologics Corp.
Eligibility
Sex/Gender
All
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 550 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 250
Exclusion criteria
Exclusion criteria: 1. Breast cancer metastases or residual disease post operatively (as determined by local assessment). 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 |
|---|---|
| Main Objective: • To collect safety, tolerability, and immunogenicity data for single agent Herceptin or TX05 in the adjuvant setting in subjects with early HER2-positive breast cancer who completed neoadjuvant treatment and primary resection in Protocol TX05-03. • To collect safety, tolerability, and immunogenicity data following a single transition from neoadjuvant Herceptin to adjuvant TX05 in this population. • To collect disease-free survival (DFS) and overall survival (OS) data in this population.;Secondary Objective: Not applicable;Primary end point(s): Safety Endpoints: • TEAEs and SAEs. • Death. • Clinical laboratory parameters. • Vital signs. • 12-lead ECG. • LVEF. • Physical examination. Immunogenicity Endpoints: • Incidence of ADA. • Incidence of Nab. 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. ;Timepoint(s) of evaluation of this end point: Safety Endpoints: Refer to table 9-1 of the protocol. Immunogenicity Endpoints: Visit 1, visit 6 and end of study visit. Efficacy Endpoints: After end of study. No interim analysis is planned. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Belarus, Brazil, Bulgaria, Chile, Georgia, Hungary, India, Mexico, Peru, Philippines, Poland, Russian Federation, Thailand, Ukraine
Contacts
Public ContactBonnie J. Mills
Tanvex Biologics Corporation
Outcome results
None listed