Trial of Exemestane +/- MM-121 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive and/or Progesterone Receptor Positive Her2 Negative Breast Cancer

Phase 2

Completed

Conditions: Her2 Negative Breast Cancer Patients

Interventions: Drug: MM-121
Drug: Placebo
Drug: Exemestane

Registration Number: NCT01151046

Lead Sponsor: Merrimack Pharmaceuticals

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 118

Inclusion Criteria

Locally advanced or metastatic breast cancer
Histologically or cytologically confirmed ER+ and/or PgR+ and Her2 negative breast cancer
≥ 18 years of age

Exclusion Criteria

Received prior treatment with exemestane
Extensive visceral disease (rapidly progressive, life-threatening metastases, including symptomatic lymphangitic metastases)
Symptomatic CNS disease

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MM-121 (SAR256212) + exemestane	MM-121	-
Placebo + exemestane	Exemestane	-
Placebo + exemestane	Placebo	-
MM-121 (SAR256212) + exemestane	Exemestane	-

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	Time from first dose to date of progression, the longest time frame of 79.1 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Time from first dose to date of death, over approximately 2 years	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.

Trial Locations

Locations (32): Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
Puerta de Hierro
🇪🇸
Madrid, Spain
Pacific Cancer Medical Center
🇺🇸
Anaheim, California, United States
Southwest Cancer Center
🇺🇸
Escondido, California, United States
Horizon Oncology Center
🇺🇸
Lafayette, Indiana, United States
Indiana University Simon Cancer Center
🇺🇸
Indianapolis, Indiana, United States
Arizona Center for Cancer Care
🇺🇸
Glendale, Arizona, United States
Tennessee Cancer Specialists, Oncology Clincial Trials Center for Biomedical Research
🇺🇸
Knoxville, Tennessee, United States
Hopital du Sacre-Coeur de Montreal
🇨🇦
Montreal, Canada
Medico-Diagnostically Center of International Institution of biological systems n.a.S.M.
🇷🇺
Berezina, Russian Federation
Pasco-Pinellas Oncology
🇺🇸
New Port Richey, Florida, United States
Achieve Clinical Research
🇺🇸
Birmingham, Alabama, United States
Hematology Oncology Associates, INC.
🇺🇸
Oakland, California, United States
Leningrad Regional Oncology Center
🇷🇺
St. Petersburg, Russian Federation
Onkogologisches zentrum Munich
🇩🇪
Munich, Germany
Hospital Parc Tauli - Barcelona
🇪🇸
Barcelona, Spain
City Clinical Oncology Center
🇷🇺
St. Petersburg, Russian Federation
Servicio de Oncología Médica / Hospital Universitario Gregorio Marañón
🇪🇸
Madrid, Spain
Vall d'Hebrón University Hospital
🇪🇸
Barcelona, Spain
Hopital Maissoneuve-Rosemont
🇨🇦
Montreal, Quebec, Canada
McGill University Jewish General Hospital
🇨🇦
Montreal, Quebec, Canada
CHA St. Sacrement
🇨🇦
Quebec, Canada
Brustzentrum HS Kliniken Wiesbaden
🇩🇪
Wiesbaden, Germany
Railway Clinical Hospital
🇷🇺
St. Petersburg, Russian Federation
Central Coast Medical Oncology Corporation
🇺🇸
Santa Maria, California, United States
Wilshire Oncology Medical Group, Inc.
🇺🇸
Corona, California, United States
San Jose Medical Center
🇺🇸
San Jose, California, United States
Beverly Hills Cancer Center
🇺🇸
Beverly Hills, California, United States
Hematology Oncology Associates of the Treasure Coast
🇺🇸
Port St. Lucie, Florida, United States
Tennessee Cancer Specialists Oncology Clinical Trials Center for Biomedical Research
🇺🇸
Knoxville, Tennessee, United States
Hospital Clinic (Barcelona)
🇪🇸
Barcelona, Spain
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States