Overview

This trial is active, not recruiting.

Condition her2 negative breast cancer patients
Treatments mm-121 (sar256212) and exemestane, placebo and exemestane
Phase phase 2
Sponsor Merrimack Pharmaceuticals
Start date June 2010
End date November 2013
Trial size 130 participants
Trial identifier NCT01151046, MM-121-02-02-03 (ARD11588)

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
mm-121 (sar256212) and exemestane
MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week and exemestane (25 mg) administered orally once per day
(Placebo Comparator)
placebo and exemestane
Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week and exemestane (25 mg) administered orally once per day

Primary Outcomes

Measure
To determine whether the combination MM-121 + exemestane is more effective than exemestane alone based on Progression Free Survival (PFS).
time frame: December 2012

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Merrimack Pharmaceuticals.