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
Status: | Recruiting |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/30/2013 |
Start Date: | June 2010 |
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
To determine whether the combination MM-121 + Exemestane in ER+ and/or PR+ breast cancer
patients is more effective than Exemestane alone
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.
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
We found this trial at
20
sites
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Site Overview Achieve has two clinical research sites in Birmingham, AL. Our Birmingham sites are conveniently located...
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535 Barnhill Dr
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(888) 600-4822
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
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Knoxville, Tennessee 37909
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Knoxville, Tennessee 37909
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