NCT00274469 (FIRST) is a Phase 2 clinical trial of fulvestrant in Metastatic Breast Cancer, sponsored by AstraZeneca.

Who is sponsoring NCT00274469?

NCT00274469 is sponsored by AstraZeneca.

What drugs are being tested in NCT00274469?

Interventions in NCT00274469: fulvestrant, anastrozole.

What condition does NCT00274469 study?

NCT00274469 studies Metastatic Breast Cancer.

Is NCT00274469 still recruiting?

NCT00274469 is currently completed. Last updated 6 September 2019.

Are results published for NCT00274469?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-09-06 · How we verify

NCT00274469: FIRST

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Clinical Trial to Compare Efficacy and Tolerability of Faslodex With Arimidex in Patients With Advanced Breast Cancer

Completed Phase 2 Results posted Last updated 6 September 2019

What this trial tests

Phase 2 trial testing fulvestrant in Metastatic Breast Cancer in 205 participants. Completed in 13 January 2017.

Timeline

6 February 2006

Primary endpoint
10 January 2008

13 January 2017

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	205
Start date	6 February 2006
Primary completion	10 January 2008
Estimated completion	13 January 2017
Sites	41 locations across France, Italy, United Kingdom, Poland, Bulgaria, Spain, United States, Brazil

Drugs / interventions tested

fulvestrant (fulvestrant) — full drug profile →
anastrozole (anastrozole) — full drug profile →

Conditions studied

Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 45 to 100, female only, with Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Clinical Benefit Rate Primary · 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.

Group	Value	95% CI
Fulvestrant 500 mg	72.5
Anastrozole 1 mg	67.0

Objective Response Rate Secondary · 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.

Group	Value	95% CI
Fulvestrant 500 mg	36.0
Anastrozole 1 mg	35.5

Time to Progression Secondary · 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.

Group	Value	95% CI
Fulvestrant 500 mg	NA	173 – NA
Anastrozole 1 mg	381	168 – NA

Time to Treatment Failure Secondary · 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

Group	Value	95% CI
Fulvestrant 500 mg	536	166 – 1303
Anastrozole 1 mg	387	169 – 838

Time to Progression (Investigator Assessed) Secondary · 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.

Group	Value	95% CI
Fulvestrant 500 mg	712	173 – 1331
Anastrozole 1 mg	400	168 – 908

Overall Survival Secondary · From randomization to data cut off (DCO) for 65% OS analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for 65% OS analysis was on 15 Jul 2014, 7 years after the last patient was enrolled.

Time from randomization to death (any cause)

Group	Value	95% CI
Fulvestrant 500 mg	54.1	29.7 – NA
Anastrozole 1 mg	48.4	28.6 – 78.5

Adverse events — posted to ClinicalTrials.gov

Time frame: Non-serious adverse events = randomisation upto the point of data cut off for the primary efficacy analysis. Serious adverse events = randomisation up to the point of data cut off for the 65% overall survival analysis.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Fulvestrant 500 mg

Serious: 24/101 (24%)

Deaths: 63/102

Anastrozole 1 mg

Serious: 22/103 (21%)

Deaths: 74/103

Serious adverse events (55 terms)

Reaction	System	Fulvestrant 500 mg	Anastrozole 1 mg
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	—	—
FEMUR FRACTURE	Injury, poisoning and procedural complications	—	—
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	—	—
CARDIAC FAILURE	Cardiac disorders	—	—
DEATH	General disorders	—	—
DECREASED APPETITE	Metabolism and nutrition disorders	—	—
DEHYDRATION	Metabolism and nutrition disorders	—	—
ATRIAL FIBRILLATION	Cardiac disorders	—	—
BRONCHITIS	Infections and infestations	—	—
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	—	—
CONFUSIONAL STATE	Psychiatric disorders	—	—
FALL	Injury, poisoning and procedural complications	—	—
GASTRIC ULCER	Gastrointestinal disorders	—	—
GASTROENTERITIS VIRAL	Infections and infestations	—	—
HUMERUS FRACTURE	Injury, poisoning and procedural complications	—	—
LACRIMAL DISORDER	Eye disorders	—	—
LYMPHADENOPATHY	Blood and lymphatic system disorders	—	—
NAUSEA	Gastrointestinal disorders	—	—
NEURALGIA	Nervous system disorders	—	—
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	—	—
PLEURITIC PAIN	Respiratory, thoracic and mediastinal disorders	—	—
PNEUMONIA	Infections and infestations	—	—
RADIUS FRACTURE	Injury, poisoning and procedural complications	—	—
VOMITING	Gastrointestinal disorders	—	—
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	—	—

Other adverse events (201 terms — click to expand)

Reaction	System	Fulvestrant 500 mg	Anastrozole 1 mg
BONE PAIN	Musculoskeletal and connective tissue disorders	—	—
HOT FLUSH	Vascular disorders	—	—
HEADACHE	Nervous system disorders	—	—
ARTHRALGIA	Musculoskeletal and connective tissue disorders	—	—
CONSTIPATION	Gastrointestinal disorders	—	—
NAUSEA	Gastrointestinal disorders	—	—
MYALGIA	Musculoskeletal and connective tissue disorders	—	—
COUGH	Respiratory, thoracic and mediastinal disorders	—	—
FATIGUE	General disorders	—	—
VOMITING	Gastrointestinal disorders	—	—
ASTHENIA	General disorders	—	—
DIARRHOEA	Gastrointestinal disorders	—	—
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	—	—
DIZZINESS	Nervous system disorders	—	—
HYPERTENSION	Vascular disorders	—	—
INFLUENZA	Infections and infestations	—	—
INJECTION SITE PAIN	General disorders	—	—
DYSPEPSIA	Gastrointestinal disorders	—	—
DYSPHONIA	Respiratory, thoracic and mediastinal disorders	—	—
OEDEMA PERIPHERAL	General disorders	—	—
URINARY TRACT INFECTION	Infections and infestations	—	—
HYPERHIDROSIS	Skin and subcutaneous tissue disorders	—	—
DEPRESSION	Psychiatric disorders	—	—
BACK PAIN	Musculoskeletal and connective tissue disorders	—	—
INFLUENZA LIKE ILLNESS	General disorders	—	—
BRONCHITIS	Infections and infestations	—	—
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	—	—
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	—	—
CYSTITIS	Infections and infestations	—	—
ALOPECIA	Skin and subcutaneous tissue disorders	—	—
ANXIETY	Psychiatric disorders	—	—
ANOREXIA	Metabolism and nutrition disorders	—	—
VERTIGO	Ear and labyrinth disorders	—	—
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	—	—
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	—	—
ABDOMINAL PAIN	Gastrointestinal disorders	—	—
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	—	—
HIATUS HERNIA	Gastrointestinal disorders	—	—
DRY MOUTH	Gastrointestinal disorders	—	—
ANAL DISCOMFORT	Gastrointestinal disorders	—	—

Most-reported serious reactions: DYSPNOEA, FEMUR FRACTURE, TRANSIENT ISCHAEMIC ATTACK, CARDIAC FAILURE, DEATH, DECREASED APPETITE, DEHYDRATION, ATRIAL FIBRILLATION.

Data from ClinicalTrials.gov NCT00274469 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Fulvestrant 500 mg Versus Anastrozole 1 mg for the First-Line Treatment of Advanced Breast Cancer: Overall Survival Analysis From the Phase II FIRST Study.
Ellis MJ, Llombart-Cussac A, Feltl D, Dewar JA, et al · · 2015 · cited 166× · PMID 26371134 · DOI 10.1200/jco.2015.61.5831
Cost-Effectiveness Analysis of Fulvestrant 500 mg in Endocrine Therapy-Naïve Postmenopausal Women with Hormone Receptor-Positive Advanced Breast Cancer in the UK.
Telford C, Bertranou E, Large S, Phelps H, et al · · 2019 · cited 8× · PMID 31025302 · DOI 10.1007/s41669-019-0134-3
A meta-analysis of clinical benefit rates for fulvestrant 500 mg vs. alternative endocrine therapies for hormone receptor-positive advanced breast cancer.
Robertson JFR, Jiang Z, Di Leo A, Ohno S, et al · · 2019 · cited 7× · PMID 31079343 · DOI 10.1007/s12282-019-00973-4

Verify or expand the search:

Other trials of fulvestrant

Trials testing the same drug.

NCT06726148 — Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Soli · Phase 1, PHASE2 · recruiting
NCT07096024 — A Study to Understand About the Study Medicine Palbociclib in Breast Cancer Patients After it is Out in the Japanese Mar · completed
NCT05384119 — Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Brea · Phase 1 · terminated
NCT05577923 — Exploring Whether Disease-free Intervals Can Guide Endocrine Combined Targeted Therapy for ER+/HER2+ Advanced Breast Can · Phase 2 · unknown
NCT05082025 — Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K · Phase 2 · terminated

Other recruiting trials for Metastatic Breast Cancer

Currently open trials in the same condition.

NCT07524855 — A Study of HLD-0117 in Patients With Metastatic Breast Cancer · Phase 1 · recruiting
NCT07408089 — Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer · Phase 1 · recruiting
NCT07340541 — Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies · Phase 2 · recruiting
NCT07233928 — Breast Cancer Organelle Properties and Protein Expression Atlas in the Three Immunohistochemical Subtypes of Breast Canc · NA · recruiting
NCT07347600 — A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, · recruiting

Other AstraZeneca trials

Trials by the same sponsor.

NCT06998095 — Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea · not yet recruiting
NCT07431775 — Saphnelo Use in Females of Child-bearing Potential · not yet recruiting
NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis · NA · not yet recruiting
NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec · Phase 4 · not yet recruiting
NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00274469 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 6 September 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00274469.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing