Clinical trial NCT01151046: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Her2 Negative Breast Cancer Patients
Keywords: Breast Cancer
Her2 negative
Estrogen Receptor Positive
Progesterone Receptor Positive
MM-121
Exemestane
Postmenopausal Women
Lead sponsor: Merrimack Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-06-25
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Time from first dose to date of progression, the longest time frame of 79.1 weeks
Secondary outcomes:
measure: Overall Survival
timeFrame: Time from first dose to date of death, over approximately 2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research
state: Alabama
city: Birmingham
country: United States
facility: Achieve Clinical Research
state: Alabama
city: Glendale
country: United States
facility: Arizona Center for Cancer Care
state: Arizona
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center
state: California
city: Beverly Hills
country: United States
facility: Beverly Hills Cancer Center
state: California
city: Corona
country: United States
facility: Wilshire Oncology Medical Group, Inc.
state: California
city: Escondido
country: United States
facility: Southwest Cancer Center
state: California
city: Oakland
country: United States
facility: Hematology Oncology Associates, INC.
state: California
city: San Jose
country: United States
facility: San Jose Medical Center
state: California
city: Santa Maria
country: United States
facility: Central Coast Medical Oncology Corporation
state: California
city: New Port Richey
country: United States
facility: Pasco-Pinellas Oncology
state: Florida
city: Port St. Lucie
country: United States
facility: Hematology Oncology Associates of the Treasure Coast
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Simon Cancer Center
state: Indiana
city: Lafayette
country: United States
facility: Horizon Oncology Center
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Knoxville
country: United States
facility: Tennessee Cancer Specialists Oncology Clinical Trials Center for Biomedical Research
state: Tennessee
city: Knoxville
country: United States
facility: Tennessee Cancer Specialists, Oncology Clincial Trials Center for Biomedical Research
state: Tennessee
city: Montreal
country: Canada
facility: Hopital Maissoneuve-Rosemont
state: Quebec
city: Montreal
country: Canada
facility: McGill University Jewish General Hospital
state: Quebec
city: Montreal
country: Canada
facility: Hopital du Sacre-Coeur de Montreal
city: Quebec
country: Canada
facility: CHA St. Sacrement
city: Munich
country: Germany
facility: Onkogologisches zentrum Munich
city: Wiesbaden
country: Germany
facility: Brustzentrum HS Kliniken Wiesbaden
city: Berezina
country: Russian Federation
facility: Medico-Diagnostically Center of International Institution of biological systems n.a.S.M.
city: St. Petersburg
country: Russian Federation
facility: Railway Clinical Hospital
city: St. Petersburg
country: Russian Federation
facility: Leningrad Regional Oncology Center
city: St. Petersburg
country: Russian Federation
facility: City Clinical Oncology Center
city: Barcelona
country: Spain
facility: Vall d'Hebrón University Hospital
city: Barcelona
country: Spain
facility: Hospital Clinic (Barcelona)
city: Barcelona
country: Spain
facility: Hospital Parc Tauli - Barcelona
city: Madrid
country: Spain
facility: Servicio de Oncología Médica / Hospital Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Puerta de Hierro
Study officials:
affiliation: Merrimack Pharmaceuticals, Inc.
name: Victor Moyo, MD
role: STUDY_DIRECTOR
References: