PAveMenT: Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer

Required: AR positive

Patients with recurrent inoperable locally advanced or metastatic AR+ triple negative breast cancer with ER, PgR and HER2 status determined locally and AR determined centrally on archival metastatic tissue. Archival tissue from the primary tumour (which must have been ER/PgR negative and collected within 5 years prior to metastatic relapse) may be used for AR testing if no archival metastatic tissue is available.

Required: ESR1 negative

ER, PgR and HER2 status determined locally

Required: PR (PGR) negative

ER, PgR and HER2 status determined locally

Required: HER2 (ERBB2) negative

ER, PgR and HER2 status determined locally

Must have received: chemotherapy — advanced disease

Previously treated with at least one prior line of chemotherapy for advanced disease, but no more than two prior lines of chemotherapy for advanced disease.

Must have received: hormone therapy — advanced disease

Patients with ER+ breast cancer must have received at least one prior line of hormone therapy for advanced disease.

Must have received: HER2-targeted therapy — advanced disease

Patients with HER2+ breast cancer must have received at least one prior line of HER2 directed therapy.

Cannot have received: oral chemotherapy

Oral chemotherapy within two weeks

Cannot have received: weekly intravenous chemotherapy

weekly iv chemotherapy within three weeks

Cannot have received: systemic chemotherapy or investigational medicinal products

any other systemic chemotherapy or investigational medicinal products during the previous four weeks

Cannot have received: hormonal therapy

Exception: luteinizing hormone-releasing hormone (LHRH) analogues for ovarian suppression

Hormonal therapy within 7 days except luteinizing hormone-releasing hormone (LHRH) analogues for ovarian suppression

Cannot have received: immune checkpoint inhibitor or immune co-stimulatory drug

Exception: Patients who have received neoadjuvant and/or adjuvant pembrolizumab are eligible if treatment was completed at 6 months prior to metastatic relapse.

Previous exposure to immune checkpoint inhibitors or immune co-stimulatory drugs in the advanced setting.

Cannot have received: CDK4/6 inhibitor (palbociclib)

Exception: Patients who have received adjuvant abemaciclib or ribociclib for early breast cancer are eligible if treatment was completed at least 12 months prior to metastatic relapse.

Previous treatment with palbociclib or any agents which inhibit CDK4/6.