Conditions: Her2 Negative Breast Cancer Patients
Keywords: Breast Cancer Her2 negative Estrogen Receptor Positive Progesterone Receptor Positive MM-121 Exemestane Postmenopausal Women
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 118
Healthy volunteers: no

Brief summary:
To determine whether the combination MM-121 + Exemestane in ER+ and/or PR+ breast cancer patients is more effective than Exemestane alone

Detailed description:
The study is a double-blind, randomized Phase 2 trial of Exemestane +/- MM-121. The trial is designed to demonstrate whether MM-121 + Exemestane is more effective than Exemestane alone in ER+ and/or PR+ and Her2 negative breast cancer patients that have failed first-line anti-estrogen therapy in the locally advanced or metastatic setting and patients that have progressed during (or within 6 months of completing) adjuvant treatment with a non-steroidal aromatase inhibitor (AI)and/or tamoxifen. Patients will be treated until radiologic or clinical progression of their disease is documented. Local radiologist and/or PI assessment is accepted.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: MM-121 intervention 2: Placebo intervention 3: Exemestane
Intervention descriptions: intervention 1: MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week intervention 2: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week and exemestane (25 mg) administered orally once per day intervention 3: Exemestane (25 mg) administered orally once per day

Protocol document: