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:

  • Conditions:
    Anatomic Stage I Hormone Receptor-positive, Her2-positive Breast Cancer
  • Age: Between 18 Year(s) - 100 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. 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.
    2. 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.
    3. Bilateral breast cancers that individually meet eligibility criteria are allowed.
    4. 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:

    1. Neoadjuvant or adjuvant chemotherapy for this breast cancer prior to enrollment is prohibited.
    2. 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.
    3. Men who are unwilling to employ adequate contraception.
    4. Participants who are receiving any other investigational agents for treatment of breast cancer.



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