Anastrazole, Fulvestrant & Abemaciclib for HR+HER2- Metastatic Breast Cancer

Required: ESR1 overexpression (≥1% of tumor cell nuclei immunoreactive by IHC)

a breast cancer must express, by immunohistochemistry (IHC), at least one of the hormone receptors (ER, progesterone receptor [PgR]) as defined in the relevant American Society of Clinical Oncology/College of American Pathologists Guidelines: For ER and PgR assays to be considered positive, ≥1% of tumor cell nuclei must be immunoreactive by immunohistochemistry (IHC)

Required: PR (PGR) overexpression (≥1% of tumor cell nuclei immunoreactive by IHC)

a breast cancer must express, by immunohistochemistry (IHC), at least one of the hormone receptors (ER, progesterone receptor [PgR]) as defined in the relevant American Society of Clinical Oncology/College of American Pathologists Guidelines: For ER and PgR assays to be considered positive, ≥1% of tumor cell nuclei must be immunoreactive by immunohistochemistry (IHC)

Required: HER2 (ERBB2) wild-type

HER2-negative Breast Cancer

Cannot have received: chemotherapy

Exception: Relapse > 12 months from completion of (neo)adjuvant endocrine and/or chemotherapy with no treatment for advanced or metastatic disease (patients with no early stage breast cancer neoadjuvant or adjuvant systemic treatment may qualify)

Patients who have had chemotherapy or radiotherapy within 12 months prior to entering the study.

Cannot have received: radiation therapy

Exception: Palliative radiotherapy does not require a washout

Patients who have had chemotherapy or radiotherapy within 12 months prior to entering the study.

Cannot have received: CDK4/6 inhibitor

Exception: CDK 4/6 inhibitor and/or endocrine therapy within 8 weeks prior to starting study treatment is allowed

For current diagnosis, CDK 4/6 inhibitor and/or endocrine therapy within 8 weeks prior to starting study treatment is allowed

Cannot have received: endocrine therapy (fulvestrant)

Exception: For the current diagnosis, fulvestrant initiated within 8 weeks prior to starting study intervention is allowed

Prior treatment with Fulvestrant (Note: For the current diagnosis, fulvestrant initiated within 8 weeks prior to starting study intervention is allowed)

Cannot have received: biologic agent

Exception: Wash out of at least three half-lives of monoclonal antibody would be required to be enrolled.

Recent therapy with a biologic agent or a monoclonal therapy is excluded. Wash out of at least three half-lives of monoclonal antibody would be required to be enrolled.