Study of MEDI-573 Plus Standard Endocrine Therapy for Women With Hormone-sensitive Metastatic Breast Cancer
NCT ID: NCT01446159
Last Updated: 2020-06-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
188 participants
INTERVENTIONAL
2011-06-13
2019-06-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MEDI-573 10 mg/kg + AI
Participants who will be enrolled in Phase 1b Cohort A of the study will receive intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
MEDI-573
Intravenous infusion of MEDI-573 (10 or 30 or 45 mg/kg) will be administered on Day 1 of each 21-day cycle until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
Aromatase Inhibitor
Aromatase inhibitor of the investigator's choice (letrozole, anastrozole, or exemestane) will be provided orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
MEDI-573 30 mg/kg + AI
Participants who will be enrolled in Phase 1b Cohort B of the study will receive intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
MEDI-573
Intravenous infusion of MEDI-573 (10 or 30 or 45 mg/kg) will be administered on Day 1 of each 21-day cycle until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
Aromatase Inhibitor
Aromatase inhibitor of the investigator's choice (letrozole, anastrozole, or exemestane) will be provided orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
MEDI-573 45 mg/kg + AI
Participants who will be enrolled in Phase 1b Cohort C and Phase 2 Arm 1 of the study will receive intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
MEDI-573
Intravenous infusion of MEDI-573 (10 or 30 or 45 mg/kg) will be administered on Day 1 of each 21-day cycle until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
Aromatase Inhibitor
Aromatase inhibitor of the investigator's choice (letrozole, anastrozole, or exemestane) will be provided orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
Aromatase Inhibitor
Participants who will be enrolled in Phase 2 Arm 2 of the study will receive oral AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
Aromatase Inhibitor
Aromatase inhibitor of the investigator's choice (letrozole, anastrozole, or exemestane) will be provided orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
Interventions
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MEDI-573
Intravenous infusion of MEDI-573 (10 or 30 or 45 mg/kg) will be administered on Day 1 of each 21-day cycle until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
Aromatase Inhibitor
Aromatase inhibitor of the investigator's choice (letrozole, anastrozole, or exemestane) will be provided orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
Eligibility Criteria
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Inclusion Criteria
* Tumors are positive for ER, PgR, or both
* Tumors must be negative for HER2 (by FISH, CISH or IHC)
* Female gender and age ≥ 18 years at time of study entry
* Postmenopausal
* Karnofsky Performance Status ≥ 70
* Life expectancy of ≥ 6 months
Exclusion Criteria
* Prior adjuvant therapy with an AI and/or tamoxifen is allowed, provided treatment ended at least 2 weeks prior to the first dose of MEDI-573
* Prior neoadjuvant and/or adjuvant chemotherapy for breast cancer is allowed
* Extensive symptomatic visceral disease including hepatic involvement and pulmonary lymphangitic spread of tumor, or disease that is considered by the investigator to be rapidly progressing or life threatening (eg, subjects who are intended for chemotherapy)
* Active brain metastases with the exception of subject has been treated and are asymptomatic and there has been no evidence of CNS progression for at least 4 weeks of first dose of MEDI-573
* Evidence of ongoing spinal cord compression or leptomeningeal carcinomatosis
* Unresolved toxicities from prior therapy with the exception of alopecia that have not resolved to ≤ Grade 1 at the time of starting study treatment
* Previous treatment with agents that target the IGF receptor
* History of allergy or reaction attributed to compounds of chemical or biologic composition similar to those of MEDI-573 or AI
* History of another invasive malignancy within 5 years except for curatively resected nonmelanoma skin cancer or carcinoma in situ of the cervix
* Poorly controlled diabetes mellitus
18 Years
99 Years
FEMALE
No
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Principal Investigators
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MedImmune LLC
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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Research Site
Scottsdale, Arizona, United States
Research Site
Bakersfield, California, United States
Research Site
Pleasant Hill, California, United States
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Stamford, Connecticut, United States
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Fort Myers, Florida, United States
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Orlando, Florida, United States
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Port Saint Lucie, Florida, United States
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St. Petersburg, Florida, United States
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Athens, Georgia, United States
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Augusta, Georgia, United States
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Lawrenceville, Georgia, United States
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Scarborough, Maine, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Frederick, Maryland, United States
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Rockville, Maryland, United States
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Ann Arbor, Michigan, United States
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Lansing, Michigan, United States
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Rochester, Minnesota, United States
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Albuquerque, New Mexico, United States
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Lake Success, New York, United States
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Lake Success, New York, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Middletown, Ohio, United States
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Toledo, Ohio, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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Richmond, Virginia, United States
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Aalst, , Belgium
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Brasschaat, , Belgium
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Bruges, , Belgium
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Brussels, , Belgium
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Edegem, , Belgium
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Leuven, , Belgium
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Mons, , Belgium
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Oshawa, Ontario, Canada
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Ottawa, Ontario, Canada
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Montreal, Quebec, Canada
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Le Mans, , France
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Montpellier, , France
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Dortmund, , Germany
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Frankfurt, , Germany
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München, , Germany
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Witten, , Germany
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Miskolc, , Hungary
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Nyíregyháza, , Hungary
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Haifa, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Rehovot, , Israel
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Tel Aviv, , Israel
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Ẕerifin, , Israel
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Lodz, , Poland
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
Research Site
Nassau, , The Bahamas
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Cardiff, , United Kingdom
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London, , United Kingdom
Research Site
Southampton, , United Kingdom
Research Site
Stoke-on-Trent, , United Kingdom
Research Site
Wolverhampton, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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CD-ON-MEDI-573-1030-Protocol\_amendment 3\_redaction-PDF-A
CD-ON-MEDI-573-1030-SAP-V1\_and\_V2\_Final\_Redacted\_PDF-A
Other Identifiers
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CD-ON-MEDI-573-1030
Identifier Type: -
Identifier Source: org_study_id
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