A Clinical Trial to Compare Efficacy and Tolerability of Faslodex With Arimidex in Patients With Advanced Breast Cancer (FIRST)
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| ClinicalTrials.gov Identifier: NCT00274469 |
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Recruitment Status :
Completed
First Posted : January 11, 2006
Results First Posted : August 12, 2009
Last Update Posted : September 6, 2019
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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Brief Summary:
The purpose of this study is to compare the efficacy and tolerability of Faslodex (fulvestrant) with Arimidex (anastrozole) in postmenopausal women with hormone receptor positive advanced breast cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metastatic Breast Cancer | Drug: fulvestrant Drug: anastrozole | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 205 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Open-Label, Parallel-Group, Multicentre, Phase II Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Anastrozole (ARIMIDEX™) 1 mg as First Line Hormonal Treatment for Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer |
| Actual Study Start Date : | February 6, 2006 |
| Actual Primary Completion Date : | January 10, 2008 |
| Actual Study Completion Date : | January 13, 2017 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
MedlinePlus related topics:
Breast Cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
Fulvestrant
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Drug: fulvestrant
500 mg intramuscular injection
Other Names:
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Active Comparator: 2
Anastrozole
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Drug: anastrozole
1 mg oral tablet
Other Names:
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Primary Outcome Measures :
- Clinical Benefit Rate [ Time Frame: From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled. ]A Clinical Benefit (CB) responder is defined as a patient having a best overall response of either complete response (CR), partial response (PR) or stable disease (SD) for at least 24 weeks evaluated according to modified RECIST. The Clinical Benefit Rate is the percentage of patients with CB.
Secondary Outcome Measures :
- Objective Response Rate [ Time Frame: From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled. ]For each patient with measurable disease at baseline, the determination of the overall response for each visit was carried out using a SAS program per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete Response (CR): Disappearance of all target lesion (TL) and non-target lesions (NTLs) and no new lesions. Partial Response (PR): At least a 30% decrease in the sum of longest diameter of TLs (compared to baseline), no progression of NTLs and no new lesions. Objective response rate is defined as percentage of patients with either CR or PR.
- Time to Progression [ Time Frame: From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled. ]Time from randomization until earlier of disease progression or death. Progression was defined according to RECIST: a patient is determined to have progressed if they have progression of target lesions, clear progression of existing non-target lesions, or the appearance of one or more new lesions. Progression of target lesions is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum of LD recorded. Kaplan-Meier estimates of median for each treatment are reported.
- Time to Treatment Failure [ Time Frame: From randomisation to data cut off (DCO) for 75% treatment failure. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007. The DCO for 75% treatment failure was on 26 Mar 2010, 32 months after the last patient was enrolled. ]Time from randomization to treatment discontinuation
- Time to Progression (Investigator Assessed) [ Time Frame: From randomisation to data cut off (DCO) for 75% treatment failure. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007. The DCO for 75% treatment failure was on 26 Mar 2010, 32 months after the last patient was enrolled. ]Time from randomization to disease progression (investigator assessed) or death from any cause. Progression was defined by investigator opinion, as patients did not have formal RECIST visits in the follow-up period after the data cut off for the primary analysis of the study.
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| Ages Eligible for Study: | 45 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Confirmed hormone receptor positive advanced breast cancer, postmenopausal women
Exclusion Criteria:
- Previous treatment for advanced breast cancer (previous treatment for early breast cancer is allowed).
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): NCT00274469
Locations
| United States, Maryland | |
| Research Site | |
| Frederick, Maryland, United States, 21701 | |
| United States, Missouri | |
| Research Site | |
| Saint Louis, Missouri, United States, 63113 | |
| United States, New Jersey | |
| Research Site | |
| Teaneck, New Jersey, United States, 07666 | |
| United States, Texas | |
| Research Site | |
| Austin, Texas, United States, 78705 | |
| Research Site | |
| Duncanville, Texas, United States, 75137 | |
| Brazil | |
| Research Site | |
| Barretos, Brazil, 14784-400 | |
| Research Site | |
| Belo Horizonte, Brazil, 30380-490 | |
| Research Site | |
| Goiânia, Brazil, 74000-000 | |
| Research Site | |
| Jaú, Brazil, 17210-120 | |
| Research Site | |
| Rio de Janeiro, Brazil, 20560-120 | |
| Research Site | |
| Sao Paulo, Brazil, 01219-010 | |
| Bulgaria | |
| Research Site | |
| Blagoevgrad, Bulgaria, 2700 | |
| Research Site | |
| Plovdiv, Bulgaria, 4000 | |
| Research Site | |
| Shumen, Bulgaria, 9700 | |
| Research Site | |
| Sofia, Bulgaria, 1233 | |
| Research Site | |
| Sofia, Bulgaria, 1527 | |
| Research Site | |
| Sofia, Bulgaria, 1784 | |
| Research Site | |
| Varna, Bulgaria, 9000 | |
| Research Site | |
| Veliko Tarnovo, Bulgaria, 5000 | |
| Research Site | |
| Vratza, Bulgaria, 3000 | |
| Czechia | |
| Research Site | |
| Brno, Czechia, 656 53 | |
| Research Site | |
| Brno, Czechia, 656 91 | |
| Research Site | |
| Jicin, Czechia, 506 43 | |
| Research Site | |
| Ostrava, Czechia, 708 52 | |
| Research Site | |
| Praha 4, Czechia, 140 00 | |
| Research Site | |
| Usti nad Labem, Czechia, 401 13 | |
| France | |
| Research Site | |
| Nice, France, 06100 | |
| Research Site | |
| Poitiers, France, 86000 | |
| Research Site | |
| Saint-cloud, France, 92210 | |
| Italy | |
| Research Site | |
| Napoli, Italy, 80131 | |
| Research Site | |
| Sassari, Italy, 07100 | |
| Poland | |
| Research Site | |
| Kraków, Poland, 31-115 | |
| Research Site | |
| Olsztyn, Poland, 10-228 | |
| Spain | |
| Research Site | |
| Barcelona, Spain, 08003 | |
| Research Site | |
| Barcelona, Spain, 08025 | |
| Research Site | |
| Córdoba, Spain, 14004 | |
| Research Site | |
| Lérida, Spain, 25198 | |
| Research Site | |
| Pontevedra, Spain, 36002 | |
| United Kingdom | |
| Research Site | |
| Derby, United Kingdom, DE22 3DT | |
| Research Site | |
| Dundee, United Kingdom, DD1 9SY | |
| Research Site | |
| Edinburgh, United Kingdom, EH4 2XU | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | AstraZeneca Faslodex Medical Science Director, MD | AstraZeneca |
Additional Information:
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00274469 |
| Other Study ID Numbers: |
D6995C00006 FIRST |
| First Posted: | January 11, 2006 Key Record Dates |
| Results First Posted: | August 12, 2009 |
| Last Update Posted: | September 6, 2019 |
| Last Verified: | August 2019 |
Keywords provided by AstraZeneca:
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oncology cancer breast cancer |
Additional relevant MeSH terms:
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Fulvestrant Anastrozole Antineoplastic Agents, Hormonal Antineoplastic Agents |
Estrogen Receptor Antagonists Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Aromatase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |