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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Her2 Negative Breast Cancer Patients

Thank you

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 CenterChicago, Illinois  60612-3824
Wilshire Oncology Medical Group, Inc.Rancho Cucamonga, California  91730
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Hematology Oncology Associates of the Treasure CoastPort St. Lucie, Florida  34952
Pacific Cancer Medical CenterAnaheim, California  92801
Central Coast Medical Oncology CorporationSanta Maria, California  93454
Horizon Oncology CenterLafayette, Indiana  47905
Indiana University Simon Cancer CenterIndianapolis, Indiana  46202
Arizona Center for Cancer CareGlendale, Arizona  85306
Beverly Hills Cancer CenterBeverly Hills, California  90211
Achieve Clinical ResearchBirmingham, Alabama  35209
Southwest Cancer CenterEscondido, California  92025
Hematology Oncology Associates, INC.Oakland, California  94609
San Jose Medical CenterSan Jose, California  95124
Pasco-Pinellas OncologyNew Port Richey, Florida  34652
Tennessee Cancer Specialists, Oncology Clincial Trials Center for Biomedical ResearchKnoxville, Tennessee  37909
Tennessee Cancer Specialists Oncology Clinical Trials Center for Biomedical ResearchKnoxville, Tennessee  37909