To determine whether the combination MM-121 + Exemestane in ER+ and/or PR+ breast cancer patients is more effective than Exemestane alone
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
118
MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week
Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week and exemestane (25 mg) administered orally once per day
Exemestane (25 mg) administered orally once per day
Progression Free Survival (PFS)
To determine whether MM-121 + exemestane was more effective than placebo + exemestane in prolonging progression-free survival. PFS was a time to event measure, and progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), "as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions". Progression free survival was defined as the number of months from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD).
Time frame: Time from first dose to date of progression, the longest time frame of 79.1 weeks
Overall Survival
To determine whether MM-121 + exemestane is more effective than placebo + exemestane in prolonging overall survival. This was a time-to-event analysis of time from first dose to date of death.
Time frame: Time from first dose to date of death, over approximately 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Achieve Clinical Research
Birmingham, Alabama, United States
Achieve Clinical Research
Birmingham, Alabama, United States
Arizona Center for Cancer Care
Glendale, Arizona, United States
Pacific Cancer Medical Center
Anaheim, California, United States
Beverly Hills Cancer Center
Beverly Hills, California, United States
Wilshire Oncology Medical Group, Inc.
Corona, California, United States
Southwest Cancer Center
Escondido, California, United States
Hematology Oncology Associates, INC.
Oakland, California, United States
San Jose Medical Center
San Jose, California, United States
Central Coast Medical Oncology Corporation
Santa Maria, California, United States
...and 23 more locations