Trial of BKM120/Tamoxifen-combination in Patients With HR-pos, HER2-neg Breast Cancer

• Status: Completed
• Trial end date: 2017-10-19
• Target enrollment: 0
• Participant gender: Female

Summary

This is a clinical trial with a molecularly stratified parallel cohort, single arm design to explore the efficacy and safety of BKM120 in combination with tamoxifen in patients with ER/PR-positive, HER2-negative breast cancer with prior exposure to antihormonal therapy, and different biomarker profiles, two of them potentially indicative of constitutive PI3K pathway activation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Essen
• Collaborators: iOMEDICO AG; Novartis Pharmaceuticals
• Treatments: Tamoxifen

Criteria

Inclusion Criteria:

• Patient has histologically and/or cytologically confirmed diagnosis of breast cancer

• Patient has radiologic or objective evidence of inoperable locally advanced, or metastatic breast cancer

• Patient has a known hormone receptor status HR-positive (ER and/or PR positive) and HER2-negative status

• Patient has a representative archival formalin-fixed tumor biopsy (metastasis or primary tumor)

• Patient has prior exposure to antihormonal therapy

• Patient has received ≤ 2 prior antihormonal treatments in the metastatic setting

• Prior treatment with tamoxifen in the (neo-)adjuvant setting is allowed but has to be discontinued for at least 1 year.

• Patient may have received up to one prior chemotherapy in the metastatic setting

• Measurable or non-measurable lesions according to RECIST v1.1 criteria

• Patient has an Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2

Exclusion Criteria:

• Patient has received previous treatment with a PI3K- or AKT-inhibitor or mTOR-inhibitors

• Prior treatment with Tamoxifen in the metastatic setting. Treatment with tamoxifen in the (neo-)adjuvant setting is allowed, but has to be discontinued for at least 1 year

• Patient has symptomatic CNS metastases

• Patient has a medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others), or patients with active severe personality disorders (defined according to DSM-IV).

• Patient has a known history of HIV infection (testing not mandatory) infection