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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

2014-07-24 14:00:53 | BioPortfolio

Summary

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

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Her2 Negative Breast Cancer Patients

Intervention

MM-121 and Exemestane, Placebo and Exemestane

Location

Pasco-Pinellas Oncology
New Port Richey
Florida
United States
34652

Status

Recruiting

Source

Merrimack Pharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:00:53-0400

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The phosphoprotein encoded by the BRCA1 gene (GENE, BRCA1). In normal cells the BRCA1 protein is localized in the nucleus, whereas in the majority of breast cancer cell lines and in malignant pleural effusions from breast cancer patients, it is localized mainly in the cytoplasm. (Science 1995;270(5237):713,789-91)

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