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

Tanvex BioPharma

Status and phase: Completed; Phase 3

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

Treatments: Biological: Herceptin (trastuzumab); Biological: TX05 (trastuzumab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04109391

TX05-03E

Details and patient eligibility

About

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.

Enrollment: 338 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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338 participants in 3 patient groups

Test Product (TX05)

Experimental group

Description:

IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received TX05 on the TX05-03 study and continued to receive TX05 in this extension study.

Treatment:

Biological: TX05 (trastuzumab)

Reference Therapy (Herceptin)

Active Comparator group

Description:

IV trastuzumab (Herceptin) TX05 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles Herceptin (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received Herceptin on the TX05-03 study and were randomized to receive Herceptin in this extension study.

Treatment:

Biological: Herceptin (trastuzumab)

Test Product (Herceptin/TX05 Transition)

Experimental group

Description:

IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received Herceptin on the TX05-03 study and were randomized to receive TX05 in this extension study.

Treatment:

Biological: TX05 (trastuzumab)