Status:
COMPLETED
Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03
Lead Sponsor:
Tanvex BioPharma USA, Inc.
Conditions:
HER2-positive Breast Cancer
Early-stage Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
This is an extension study to provide adjuvant treatment with single agent Herceptin or TX05 and assess continued safety and immunogenicity in subjects with HER2-positive early breast cancer following...
Eligibility Criteria
Inclusion
- Signed written informed consent.
- Females ≥ 18 years of age.
- 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.
- 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.
- Able to comply with the study protocol.
- 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
- Breast cancer metastases or residual disease post operatively (as determined by local assessment).
- 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.
- Lactating or pregnant female.
- 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.
- Any condition that in the opinion of the Investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for subjects.
Key Trial Info
Start Date :
August 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2022
Estimated Enrollment :
338 Patients enrolled
Trial Details
Trial ID
NCT04109391
Start Date
August 20 2019
End Date
March 8 2022
Last Update
October 26 2022
Active Locations (86)
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1
Tanvex Investigational Site 1006E
Grodno, Belarus, 230017
2
Tanvex Investigational Site 1003E
Homyel, Belarus, 246012
3
Tanvex Investigational Site 1008E
Lesnoy, Belarus, 223040
4
Tanvex Investigational Site 1002E
Minsk, Belarus, 220013