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

Her2 Negative Breast Cancer Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01151046
• Other study ID #: MM-121-02-02-03 (ARD11588)
• Status: Active, not recruiting
• Phase: Phase 2
• First received: June 24, 2010
• Last updated: November 21, 2013
• Start date: June 2010
• Est. completion date: June 2014

Study information

• Verified date: November 2013
• Source: Merrimack Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: June 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Her2 Negative Breast Cancer Patients

Intervention

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
• 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

Locations

Country	Name	City	State
Canada	Hopital du Sacre-Coeur de Montreal	Montreal
Canada	Hopital Maissoneuve-Rosemont	Montreal	Quebec
Canada	McGill University Jewish General Hospital	Montreal	Quebec
Canada	CHA St. Sacrement	Quebec
Germany	Onkogologisches zentrum Munich	Munich
Germany	Brustzentrum HS Kliniken Wiesbaden	Wiesbaden
Russian Federation	Medico-Diagnostically Center of International Institution of biological systems n.a.S.M.	Berezina
Russian Federation	City Clinical Oncology Center	St. Petersburg
Russian Federation	Leningrad Regional Oncology Center	St. Petersburg
Russian Federation	Railway Clinical Hospital	St. Petersburg
Spain	Hospital Clinic (Barcelona)	Barcelona
Spain	Hospital Parc Tauli - Barcelona	Barcelona
Spain	Vall d'Hebrón University Hospital	Barcelona
Spain	Puerta de Hierro	Madrid
Spain	Servicio de Oncología Médica / Hospital Universitario Gregorio Marañón	Madrid
United States	Pacific Cancer Medical Center	Anaheim	California
United States	Beverly Hills Cancer Center	Beverly Hills	California
United States	Achieve Clinical Research	Birmingham	Alabama
United States	Achieve Clinical Research	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Rush University Medical Center	Chicago	Illinois
United States	Wilshire Oncology Medical Group, Inc.	Corona	California
United States	Southwest Cancer Center	Escondido	California
United States	Arizona Center for Cancer Care	Glendale	Arizona
United States	Indiana University Simon Cancer Center	Indianapolis	Indiana
United States	Tennessee Cancer Specialists Oncology Clinical Trials Center for Biomedical Research	Knoxville	Tennessee
United States	Tennessee Cancer Specialists, Oncology Clincial Trials Center for Biomedical Research	Knoxville	Tennessee
United States	Horizon Oncology Center	Lafayette	Indiana
United States	Pasco-Pinellas Oncology	New Port Richey	Florida
United States	Hematology Oncology Associates, INC.	Oakland	California
United States	Hematology Oncology Associates of the Treasure Coast	Port St. Lucie	Florida
United States	San Jose Medical Center	San Jose	California
United States	Central Coast Medical Oncology Corporation	Santa Maria	California

Sponsors (1)

Lead Sponsor	Collaborator
Merrimack Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine whether the combination MM-121 + exemestane is more effective than exemestane alone based on Progression Free Survival (PFS).		December 2012	No