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

April 11, 2016 updated by: Merrimack Pharmaceuticals

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Actual)

118

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Montreal, Canada, H4J 1C5
        • Hopital du Sacre-Coeur de Montreal
      • Quebec, Canada, G1S 4L8
        • CHA St. Sacrement
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • McGill University Jewish General Hospital
      • Montreal, Quebec, Canada, H1T2M4
        • Hopital Maissoneuve-Rosemont
  • Germany
      • Munich, Germany, 80836
        • Onkogologisches zentrum Munich
      • Wiesbaden, Germany, 65189
        • Brustzentrum HS Kliniken Wiesbaden
  • Russian Federation
      • Berezina, Russian Federation
        • Medico-Diagnostically Center of International Institution of biological systems n.a.S.M.
      • St. Petersburg, Russian Federation, 125271
        • Railway Clinical Hospital
      • St. Petersburg, Russian Federation, 188663
        • Leningrad Regional Oncology Center
      • St. Petersburg, Russian Federation, 197022
        • City Clinical Oncology Center
  • Spain
      • Barcelona, Spain, 8035
        • Vall d'Hebron University Hospital
      • Barcelona, Spain, 8036
        • Hospital Clinic (Barcelona)
      • Barcelona, Spain, 8208
        • Hospital Parc Tauli - Barcelona
      • Madrid, Spain, 28007
        • Servicio de Oncología Médica / Hospital Universitario Gregorio Marañón
      • Madrid, Spain, 28220
        • Puerta de Hierro
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Achieve Clinical Research
      • Birmingham, Alabama, United States, 35209
        • Achieve Clinical Research
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Arizona Center for Cancer Care
    • California
      • Anaheim, California, United States, 92801
        • Pacific Cancer Medical Center
      • Beverly Hills, California, United States, 90211
        • Beverly Hills Cancer Center
      • Corona, California, United States, 92879
        • Wilshire Oncology Medical Group, Inc.
      • Escondido, California, United States, 92025
        • Southwest Cancer Center
      • Oakland, California, United States, 94609
        • Hematology Oncology Associates, Inc.
      • San Jose, California, United States, 95124
        • San Jose Medical Center
      • Santa Maria, California, United States, 93454
        • Central Coast Medical Oncology Corporation
    • Florida
      • New Port Richey, Florida, United States, 34652
        • Pasco-Pinellas Oncology
      • Port St. Lucie, Florida, United States, 34952
        • Hematology Oncology Associates of the Treasure Coast
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Simon Cancer Center
      • Lafayette, Indiana, United States, 47905
        • Horizon Oncology Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Tennessee Cancer Specialists Oncology Clinical Trials Center for Biomedical Research
      • Knoxville, Tennessee, United States, 37909
        • Tennessee Cancer Specialists, Oncology Clincial Trials Center for Biomedical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MM-121 (SAR256212) + exemestane
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 Names:
  • SAR256212
Drug: Exemestane
Exemestane (25 mg) administered orally once per day
Other Names:
  • Aromasin
Placebo Comparator: Placebo + exemestane
Drug: Exemestane
Exemestane (25 mg) administered orally once per day
Other Names:
  • Aromasin
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: Time from first dose to date of progression, the longest time frame of 79.1 weeks
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).
Time from first dose to date of progression, the longest time frame of 79.1 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Time from first dose to date of death, over approximately 2 years
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.
Time from first dose to date of death, over approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merrimack Pharmaceuticals

Investigators

  • Study Director: Victor Moyo, MD, Merrimack Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

June 24, 2010

First Submitted That Met QC Criteria

June 24, 2010

First Posted (Estimate)

June 25, 2010

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

April 11, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MM-121-02-02-03 (ARD11588)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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