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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01151046
First received: June 24, 2010
Last updated: April 11, 2016
Last verified: April 2016

June 24, 2010
April 11, 2016
June 2010
June 2014   (final data collection date for primary outcome measure)
Progression Free Survival (PFS) [ Time Frame: Time from first dose to date of progression, the longest time frame of 79.1 weeks ] [ Designated as safety issue: No ]
To determine whether MM-121 + exemestane was more effective than placebo + exemestane in prolonging progression-free survival. PFS was a time to event measure, and progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), "as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions". Progression free survival was defined as the number of months from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD).
Not Provided
Complete list of historical versions of study NCT01151046 on ClinicalTrials.gov Archive Site
Overall Survival [ Time Frame: Time from first dose to date of death, over approximately 2 years ] [ Designated as safety issue: No ]
To determine whether MM-121 + exemestane is more effective than placebo + exemestane in prolonging overall survival. This was a time-to-event analysis of time from first dose to date of death.
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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
    MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week
    Other Name: SAR256212
  • Drug: Placebo
    Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week and exemestane (25 mg) administered orally once per day
  • Drug: Exemestane
    Exemestane (25 mg) administered orally once per day
    Other Name: Aromasin
  • Experimental: MM-121 (SAR256212) + exemestane
    Interventions:
    • Drug: MM-121
    • Drug: Exemestane
  • Placebo Comparator: Placebo + exemestane
    Interventions:
    • Drug: Placebo
    • Drug: Exemestane
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
118
September 2014
June 2014   (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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Germany,   Russian Federation,   Spain
 
NCT01151046
MM-121-02-02-03 (ARD11588)
Yes
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Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
Not Provided
Study Director: Victor Moyo, MD Merrimack Pharmaceuticals, Inc.
Merrimack Pharmaceuticals
April 2016

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