A clinical study to assess continued safety and immunogencity of trastuzumab in women with HER2 Positive Early breast cancer following primary treatment and surgery.
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2019/08/020723
- Lead Sponsor
- Tanvex Biologics Corp
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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.
- Breast cancer metastases or residual disease postoperatively.
- Lactating or pregnant female.
- Women of childbearing potential who do not consent to use highly effective methods of birth control
- Any condition that in the opinion of the Investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for subjects.
- History or presence of a medical condition or disease that in the investigator opinion would place the subject at an unacceptable risk for study participation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method