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

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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
220 S Palisade Dr # 204
Santa Maria, California 93454
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Anaheim, California 92801
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Beverly Hills, California 90211
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Boynton Beach, Florida 33435
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Glendale, Arizona 85306
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535 Barnhill Dr
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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Indianapolis, IN
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Knoxville, TN
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Lafayette, Indiana 47905
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Murrieta, California 92563
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New Port Richey, Florida 34652
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Oakland, California 94609
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Pomona, California 91767
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Port St. Lucie, FL
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San Francisco, California 94115
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San Jose, California 95124
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Shreveport, Louisiana
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