A Multicenter Phase I/II Trial of Anastrozole Palbociclib Trastuzumab and Pertuzumab in HR-positive Her2-positive Metastatic Breast Cancer (ASPIRE)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Hr-positive, Her2-positive Metastatic Breast Cancer
  • Age: Between 18 - 100 Years
  • Gender: Female
  • Other Inclusion Criteria:
    1) Women with metastatic breast cancer, measurable or evaluable disease including bone metastasis only. 2) No prior systemic treatment for metastatic breast cancer. 3) Pathologic confirmation of metastatic breast cancer diagnosed by core needle biopsy. 4) Metastatic breast cancer with any evidence of ER or PR positivity in = 1% cells in biopsy specimens from either a primary or metastatic site is eligible.

You may not be eligible for this study if the following are true:

  • 1) HER2 negative metastatic breast carcinoma. 2) Any prior treatment for metastatic breast cancer (excluding radiation therapy for the purpose of ovarian ablation). Note: Prior adjuvant therapy with trastuzumab and pertuzumab is permitted after a 6-month window following completion of adjuvant therapy has passed. 3) Patients currently receiving anticancer therapies or who have received anticancer therapies within 2 weeks of the start of study drug (including chemotherapy, radiation therapy, and biologics). Patients who have received prior endocrine therapy for fertility purposes will be eligible. 4) Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study.

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