CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 118 enrolled
Drug / intervention
MM-121 +2 moredrug
Likely dose
MM-121 40mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01151046
NCT01151046Phase 2Completed
CompareCT.gov

A Randomized Double-Blind Phase 2 Trial of Exemestane +/- MM-121 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive (ER+) and/or Progesterone Receptor Positive (PR+) Her2 Negative Breast Cancer

Merrimack Pharmaceuticals·interventional·Posted Jun 25, 2010·Updated May 12, 2016

In Brief

A Phase 2 clinical trial evaluating MM-121, Placebo, and 1 other intervention for Her2 Negative Breast Cancer Patients. Completed, enrolled 118 participants across 33 sites in 5 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHer2 Negative Breast Cancer Patients
CountriesCanada, Germany, Russia, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 25, 2010
Enrollment StartJun 1, 2010
Primary CompletionJun 1, 2014
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 16.0 years ago

Interventions

MM-121drug

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

Placebodrug

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

Exemestanedrug

Exemestane (25 mg) administered orally once per day