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
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| ClinicalTrials.gov Identifier: NCT01151046 |
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Recruitment Status :
Completed
First Posted : June 25, 2010
Results First Posted : May 12, 2016
Last Update Posted : May 12, 2016
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Sponsor:
Merrimack Pharmaceuticals
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
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Brief Summary:
To determine whether the combination MM-121 + Exemestane in ER+ and/or PR+ breast cancer patients is more effective than Exemestane alone
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Her2 Negative Breast Cancer Patients | Drug: MM-121 Drug: Placebo Drug: Exemestane | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 118 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| 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 Start Date : | June 2010 |
| Actual Primary Completion Date : | June 2014 |
| Actual Study Completion Date : | September 2014 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
MedlinePlus related topics:
Breast Cancer
Drug Information available for:
Exemestane
| Arm | Intervention/treatment |
|---|---|
| Experimental: MM-121 (SAR256212) + exemestane |
Drug: MM-121
MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week
Other Name: SAR256212 Drug: Exemestane Exemestane (25 mg) administered orally once per day
Other Name: Aromasin |
| Placebo Comparator: Placebo + exemestane |
Drug: Placebo
Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week and exemestane (25 mg) administered orally once per day Drug: Exemestane Exemestane (25 mg) administered orally once per day
Other Name: Aromasin |
Primary Outcome Measures :
- Progression Free Survival (PFS) [ Time Frame: Time from first dose to date of progression, the longest time frame of 79.1 weeks ]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).
Secondary Outcome Measures :
- Overall Survival [ Time Frame: Time from first dose to date of death, over approximately 2 years ]To determine whether MM-121 + exemestane is more effective than placebo + exemestane in prolonging overall survival. This was a time-to-event analysis of time from first dose to date of death.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01151046
Locations
Show 33 study locations
Sponsors and Collaborators
Merrimack Pharmaceuticals
Investigators
| Study Director: | Victor Moyo, MD | Merrimack Pharmaceuticals, Inc. |
| Responsible Party: | Merrimack Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01151046 |
| Other Study ID Numbers: |
MM-121-02-02-03 (ARD11588) |
| First Posted: | June 25, 2010 Key Record Dates |
| Results First Posted: | May 12, 2016 |
| Last Update Posted: | May 12, 2016 |
| Last Verified: | April 2016 |
Keywords provided by Merrimack Pharmaceuticals:
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Breast Cancer Her2 negative Estrogen Receptor Positive Progesterone Receptor Positive |
MM-121 Exemestane Postmenopausal Women |
Additional relevant MeSH terms:
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Exemestane Antineoplastic Agents Aromatase Inhibitors |
Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |