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
18 Years
N/A
Female
Her2 Negative Breast Cancer Patients
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
To determine whether the combination MM-121 + exemestane is more effective than exemestane alone based on Progression Free Survival (PFS).
Outcome Time Frame:
December 2012
Safety Issue:
No
Principal Investigator
Victor Moyo, MD
Investigator Role:
Study Director
Investigator Affiliation:
Merrimack Pharmaceuticals, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
MM-121-02-02-03 (ARD11588)
NCT ID:
NCT01151046
Start Date:
June 2010
Completion Date:
September 2013
Related Keywords:
- Her2 Negative Breast Cancer Patients
- Breast Cancer
- Her2 negative
- Estrogen Receptor Positive
- Progesterone Receptor Positive
- MM-121
- Exemestane
- Postmenopausal Women
- Breast Neoplasms
Name | Location |
|---|---|
| Rush University Medical Center | Chicago, Illinois 60612-3824 |
| Wilshire Oncology Medical Group, Inc. | Rancho Cucamonga, California 91730 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
| Hematology Oncology Associates of the Treasure Coast | Port St. Lucie, Florida 34952 |
| Pacific Cancer Medical Center | Anaheim, California 92801 |
| Central Coast Medical Oncology Corporation | Santa Maria, California 93454 |
| Horizon Oncology Center | Lafayette, Indiana 47905 |
| Indiana University Simon Cancer Center | Indianapolis, Indiana 46202 |
| Arizona Center for Cancer Care | Glendale, Arizona 85306 |
| Beverly Hills Cancer Center | Beverly Hills, California 90211 |
| Achieve Clinical Research | Birmingham, Alabama 35209 |
| Southwest Cancer Center | Escondido, California 92025 |
| Hematology Oncology Associates, INC. | Oakland, California 94609 |
| San Jose Medical Center | San Jose, California 95124 |
| Pasco-Pinellas Oncology | New Port Richey, Florida 34652 |
| Tennessee Cancer Specialists, Oncology Clincial Trials Center for Biomedical Research | Knoxville, Tennessee 37909 |
| Tennessee Cancer Specialists Oncology Clinical Trials Center for Biomedical Research | Knoxville, Tennessee 37909 |
