Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients
NCT ID: NCT01202591
Last Updated: 2016-02-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
127 participants
INTERVENTIONAL
2010-12-31
2014-10-31
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
TRIPLE
Study Groups
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AZD4547 + exemestane
Safety run-in: AZD4547 plus exemestane
AZD4547
Tablet oral twice daily
Exemestane
Tablet oral once daily
AZD4547 + fulvestrant
A Randomised phase IIa: AZD4547 plus fulvestrant
AZD4547
Tablet oral twice daily
Fulvestrant
A monthly intramuscular injection of a depot formulation with a loading dose 14 days after initial administration
Placebo + fulvestrant
Randomised phase IIa: Matching placebo plus fulvestrant
Placebo
Tablet oral twice daily
Fulvestrant
A monthly intramuscular injection of a depot formulation with a loading dose 14 days after initial administration
Interventions
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AZD4547
Tablet oral twice daily
Exemestane
Tablet oral once daily
Placebo
Tablet oral twice daily
Fulvestrant
A monthly intramuscular injection of a depot formulation with a loading dose 14 days after initial administration
Eligibility Criteria
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Inclusion Criteria
* Histological confirmation of Breast Cancer with documented ER+ receptor status
* Safety run-in: Relapsing during/within 12 months of completion of a single regimen of adjuvant endocrine therapy with non-steroidal AI and/ tamoxifen or progression following 1st line endocrine therapy with non-steroidal AL
* Rand phase IIa: Received at least 1 prior endocrine therapy in the metastatic setting or have relapsed during/ within 6 months of completion of adjuvant endocrine therapy (either non-steroidal AI or tamoxifen or a combination of both). Chemotherapy administered in the adjuvant setting is permitted.
* Rand phase IIa: Mandatory provision of tumour sample to confirm FGFR1 polysomy or gene amplification. At least one measurable lesion that can be accurately assessed by CT/MRI/x-ray at baseline and follow up visits
Exclusion Criteria
* More than 1 prior regimen of chemotherapy for breast cancer
* ECG recordings that demonstrate significant abnormalities in cardiac rate, rhythm or conduction
* History of hypersensitivity to active or inactive excipients of AZD4547 or exemestane (safety run-in ) or fulvestrant (Randomized phase), including castor oil, or drugs with a similar chemical structure or class to AZD4547 or exemestane or fulvestrant.
* Randomized phase IIa: bleeding/blood clotting conditions that would prevent the administration of the fulvestrant injection into the buttocks
18 Years
99 Years
FEMALE
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Donal Landers
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Leuven, , Belgium
Research Site
Namur, , Belgium
Research Site
Brno, , Czechia
Research Site
Prague, , Czechia
Research Site
Villejuif, , France
Research Site
Erlangen, , Germany
Research Site
München, , Germany
Research Site
Rostock, , Germany
Research Site
Budapest, , Hungary
Research Site
Kaposvár, , Hungary
Research Site
Nyíregyháza, , Hungary
Research Site
Szeged, , Hungary
Research Site
Genova, , Italy
Research Site
Lido di Camaiore, , Italy
Research Site
Roma, , Italy
Research Site
Cluj-Napoca, , Romania
Research Site
Dundee, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Manchester, , United Kingdom
Research Site
Oxford, , United Kingdom
Research Site
Sutton, , United Kingdom
Countries
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Other Identifiers
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2010-021220-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D2610C00003
Identifier Type: -
Identifier Source: org_study_id
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