Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03
Condition: HER2-positive Breast Cancer; Early-stage Breast Cancer; Breast Cancer; Breast Neoplasms; Stage II Breast Cancer; Stage IIIA Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: TX05 (trastuzumab); Herceptin (trastuzumab)
Intervention description: Subjects will receive up to 13 cycles of adjuvant treatment.; Subjects will receive up to 13 cycles of adjuvant treatment.
Intervention MeSH terms: Trastuzumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 338.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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.