Status:
COMPLETED
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
Lead Sponsor:
Merrimack Pharmaceuticals
Conditions:
Her2 Negative Breast Cancer Patients
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 P...
Eligibility Criteria
Inclusion
- Locally advanced or metastatic breast cancer
- Histologically or cytologically confirmed ER+ and/or PgR+ and Her2 negative breast cancer
- ≥ 18 years of age
Exclusion
- Received prior treatment with exemestane
- Extensive visceral disease (rapidly progressive, life-threatening metastases, including symptomatic lymphangitic metastases)
- Symptomatic CNS disease
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT01151046
Start Date
June 1 2010
End Date
September 1 2014
Last Update
May 12 2016
Active Locations (33)
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1
Achieve Clinical Research
Birmingham, Alabama, United States, 35209
2
Achieve Clinical Research
Birmingham, Alabama, United States, 35216
3
Arizona Center for Cancer Care
Glendale, Arizona, United States, 85306
4
Pacific Cancer Medical Center
Anaheim, California, United States, 92801