PQR309 and Eribulin in Metastatic HER2 Negative and Triple-negative Breast Cancer (PIQHASSO)

Inclusion Criteria:

• Histologically/cytologically confirmed diagnosis of breast cancer. Radiologicalevidence of inoperable locally advanced or metastatic breast cancer.

• HER2 negative breast cancer (based on the most recent analyzed biopsy) defined as anegative in situ hybridization test or an immunohistochemistry status of 0, 1+ or 2+.

• Received at least 2 and no more than 5 prio chemotherapeutic regimens in locallyadvanced and/or metastatic setting.

• Prior therapy has to include an anthracycline and a taxane in any combination ororder.

• For Expansion part: Triple-negative breast cancer defined as a negative in situ hybridization test or animmunohistochemistry (IHC) status of 0,1+ or 2+ER abnd PR status <10% by local laboratorytesting.

Exclusion Criteria:

• Previous systemic treatment with PI3K,mTOR or AKT inhibitors (allowed in theescalation part).

• Previous treatment with eribulin (allowed in the escalation part). Knownhypersensitivity to any of the excipients of PQR309 or eribulin.Concurrent treatmentwith other approved or investigational antineoplastic agent.

• Symptomatic Central Nervous System metastases. The patient must have completed anyprior local treatment for CNS metastases > 28 days prior to first dose of the studydrug (including radiotherapy and/or surgery).

• Clinically manifested diabetes mellitus(treated and/or clinical signs with fastingglucose >125mg/dl or HbA1c>7%), or documented steroid induced diabetes mellitus.