Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03

Phase 3

Completed

• Conditions: Breast Neoplasms; Early-stage Breast Cancer; Breast Cancer; HER2-positive Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer

• Registration Number: NCT04109391
• Lead Sponsor: Tanvex BioPharma USA, Inc.

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 neoadjuvant treatment and surgical resection in Protocol TX05-03.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-20
• Study First Submitted: 2019-09-20
• Study First Submitted QC: 2019-09-26
• Study First Posted: 2019-09-30
• Primary Completion: 2021-12-25
• Study Completion: 2022-03-08
• Status Verified: 2022-04
• Results First Submitted: 2022-10-04
• Results First Submitted QC: 2022-10-04
• Last Update Submitted: 2022-10-04
• Results First Posted: 2022-10-26
• Last Update Posted: 2022-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 338

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Immunogenicity Assessments (ADA and Nab)	Assessed from first infusion through end of treatment (Week 45) or Early Termination visit. Each cycle is 3 weeks.	Samples for the evaluation of anti-drug antibodies (ADA), including neutralizing antibodies (Nab) were obtained before the administration of Cycle 1 (Week 0), Cycle 6 (Week 15), and the EOT/ET Visit. Only subjects with a positive ADA result were further tested for ADA cross-reactivity and Nab. Only subjects with a positive Nab result were further tested for Nab cross-reactivity.
Disease-Free Survival	Through study completion/end of treatment (Week 45).	DFS, defined as the time from randomization in the neoadjuvant study (Protocol TX05-03) to the documentation of a first failure, where a failure was the recurrence of breast cancer or a diagnosis of a second primary cancer.
Overall Survival	Through study completion/end of treatment (Week 45).	OS, defined as the time from randomization in the neoadjuvant study (Protocol TX05-03) until death from any cause.

Trial Locations

Locations (86)

Tanvex Investigational Site 1003E; 🇧🇾 Gomel, Belarus

Tanvex Investigational Site 1006E; 🇧🇾 Grodno, Belarus

Tanvex Investigational Site 1008E; 🇧🇾 Lesnoy, Belarus

Tanvex Investigational Site 1002E; 🇧🇾 Minsk, Belarus

Tanvex Investigational Site 1005E; 🇧🇾 Mogilev, Belarus

Tanvex Investigational Site 1001E; 🇧🇾 Vitebsk, Belarus

Tanvex Investigational Site 4001E; 🇨🇱 Temuco, Chile

Tanvex Investigational Site 4002E; 🇨🇱 Vina del Mar, Chile

Tanvex Investigational Site 5006E; 🇬🇪 Batumi, Georgia

Tanvex Investigational Site 5002E; 🇬🇪 Batumi, Georgia

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