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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01151046
First received: June 24, 2010
Last updated: November 21, 2013
Last verified: November 2013

June 24, 2010
November 21, 2013
June 2010
November 2013   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01151046 on ClinicalTrials.gov Archive Site
Not Provided
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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
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Her2 Negative Breast Cancer Patients
  • Drug: 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
  • Drug: 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
  • Experimental: MM-121 (SAR256212) and exemestane
    Intervention: Drug: MM-121 (SAR256212) and Exemestane
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo and Exemestane
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
130
June 2014
November 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Canada,   Russian Federation,   Spain
 
NCT01151046
MM-121-02-02-03 (ARD11588)
Yes
Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
Not Provided
Study Director: Victor Moyo, MD Merrimack Pharmaceuticals, Inc.
Merrimack Pharmaceuticals
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP