MedTrace Logo

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

NCT01151046 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2016-05-12

Study results available
· View outcomes & findings →

Summary

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

Conditions

  • Her2 Negative Breast Cancer Patients

Interventions

DRUG

MM-121

MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week

DRUG

Placebo

Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week and exemestane (25 mg) administered orally once per day

DRUG

Exemestane

Exemestane (25 mg) administered orally once per day

Sponsors & Collaborators

  • Merrimack Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Victor Moyo, MD · Merrimack Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2014-06-30
Completion
2014-09-30

Countries

  • United States
  • Canada
  • Germany
  • Russia
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01151046 on ClinicalTrials.gov