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

NCT01151046 | Completed Phase 2 Results DMC

• 1 other identifier: MM-121-02-02-03 (ARD11588)
• Study Type: interventional
• Target: 118
• Locations: 5 countries
• Sites: 33

Brief Summary

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

Conditions

Her2 Negative Breast Cancer Patients

Keywords

Breast Cancer; Her2 negative; Estrogen Receptor Positive; Progesterone Receptor Positive; MM-121; Exemestane; Postmenopausal Women

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  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 Outcomes (1)

• Overall Survival

  Time from first dose to date of death, over approximately 2 years

Study Arms (2)

MM-121 (SAR256212) + exemestane

EXPERIMENTAL

Drug: MM-121; Drug: Exemestane

Placebo + exemestane

PLACEBO COMPARATOR

Drug: Placebo; Drug: Exemestane

Interventions

MM-121 DRUG

MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week

Also known as: SAR256212

MM-121 (SAR256212) + exemestane

Placebo DRUG

Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week and exemestane (25 mg) administered orally once per day

Placebo + exemestane

Exemestane DRUG

Exemestane (25 mg) administered orally once per day

Also known as: Aromasin

MM-121 (SAR256212) + exemestane; Placebo + exemestane

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Locally advanced or metastatic breast cancer
• Histologically or cytologically confirmed ER+ and/or PgR+ and Her2 negative breast cancer
• ≥ 18 years of age

You may not qualify if:

• Received prior treatment with exemestane
• Extensive visceral disease (rapidly progressive, life-threatening metastases, including symptomatic lymphangitic metastases)
• Symptomatic CNS disease

Sponsors & Collaborators

• Merrimack Pharmaceuticals: lead

Study Sites (33)

Achieve Clinical Research

Birmingham, Alabama, 35209, United States

Location

Achieve Clinical Research

Birmingham, Alabama, 35216, United States

Location

Arizona Center for Cancer Care

Glendale, Arizona, 85306, United States

Location

Pacific Cancer Medical Center

Anaheim, California, 92801, United States

Location

Beverly Hills Cancer Center

Beverly Hills, California, 90211, United States

Location

Wilshire Oncology Medical Group, Inc.

Corona, California, 92879, United States

Location

Southwest Cancer Center

Escondido, California, 92025, United States

Location

Hematology Oncology Associates, INC.

Oakland, California, 94609, United States

Location

San Jose Medical Center

San Jose, California, 95124, United States

Location

Central Coast Medical Oncology Corporation

Santa Maria, California, 93454, United States

Location

Pasco-Pinellas Oncology

New Port Richey, Florida, 34652, United States

Location

Hematology Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, 34952, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Horizon Oncology Center

Lafayette, Indiana, 47905, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Tennessee Cancer Specialists Oncology Clinical Trials Center for Biomedical Research

Knoxville, Tennessee, 37909, United States

Location

Tennessee Cancer Specialists, Oncology Clincial Trials Center for Biomedical Research

Knoxville, Tennessee, 37909, United States

Location

Hopital Maissoneuve-Rosemont

Montreal, Quebec, H1T2M4, Canada

Location

McGill University Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Hopital du Sacre-Coeur de Montreal

Montreal, H4J 1C5, Canada

Location

CHA St. Sacrement

Québec, G1S 4L8, Canada

Location

Onkogologisches zentrum Munich

Munich, 80836, Germany

Location

Brustzentrum HS Kliniken Wiesbaden

Wiesbaden, 65189, Germany

Location

Medico-Diagnostically Center of International Institution of biological systems n.a.S.M.

Berezina, Russia

Location

Railway Clinical Hospital

Saint Petersburg, 125271, Russia

Location

Leningrad Regional Oncology Center

Saint Petersburg, 188663, Russia

Location

City Clinical Oncology Center

Saint Petersburg, 197022, Russia

Location

Vall d'Hebrón University Hospital

Barcelona, 8035, Spain

Location

Hospital Clinic (Barcelona)

Barcelona, 8036, Spain

Location

Hospital Parc Tauli - Barcelona

Barcelona, 8208, Spain

Location

Servicio de Oncología Médica / Hospital Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Puerta de Hierro

Madrid, 28220, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

seribantumab; exemestane

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: Merrimack Pharmaceuticals

smathews@merrimack.com

617-441-1000

Study Officials

• Victor Moyo, MD

  Merrimack Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2010
• First Posted: June 25, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: September 1, 2014
• Last Updated: May 12, 2016
• Results First Posted: May 12, 2016

Record last verified: 2016-04

Locations

CA (4); US (18); DE (2); RU (4); ES (5)