A single arm phase II study of ADjuvant Endocrine therapy subcutaneous Pertuzumab and Trastuzumab fixed-dose combination for patients with anatomic stage I hormone receptor-positive HER2-positive breast cancer (ADEPT)
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Anatomic Stage I Hormone Receptor-positive, Her2-positive Breast Cancer
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Age: Between 18 Year(s) - 100 Year(s)
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Gender: Male or Female
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Other Inclusion Criteria:
- HER2-positive T1 histologically confirmed invasive carcinoma of the breast. Patients must have node-negative (N0) or micrometastases (N1mi) breast cancer according to the JCC 8th edition anatomic staging table.
- For unifocal disease, all invasive disease must have been tested for ER and PR. Either ER or PR must be positive, defined as ER>10% or PR>10%. ER- and PR-assays should be performed by immunohistochemical methods according to the local institution standard protocol.
- Bilateral breast cancers that individually meet eligibility criteria are allowed.
- Patients with multifocal or multicentric disease are eligible as long as each tumor individually meets eligibility criteria.
You may not be eligible for this study if the following are true:
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- Neoadjuvant or adjuvant chemotherapy for this breast cancer prior to enrollment is prohibited.
- Any of the following due to teratogenic potential of the study drugs: Pregnant women, ?Nursing women,? Women of childbearing potential who are unwilling to employ adequate contraception.
- Men who are unwilling to employ adequate contraception.
- Participants who are receiving any other investigational agents for treatment of breast cancer.
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.