Breast CancerPhase 3CONFIRMNCT00099437
Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.
A Phase 3 study testing Fulvestrant in people with Breast Cancer, run by AstraZeneca at 106 sites in 17 countries.
Trial summary
The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment. Read more about this study
- Who is it for?
- Ages 45 to 130 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Fulvestrant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 736 participants
- Where
- 106 sitesin 17 countries
- Study dates
- 13 Feb 2005to 31 Dec 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 130 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor
- Requiring hormonal treatment
- Postmenopausal women defined as a woman who has stopped having menstrual periods
- Evidence of positive estrogen receptor hormone sensitivity
- Written informed consent to participate in the trial
Who cannot join
- Treatment with an investigational or non-approved drug within one month
- An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
- A history of allergies to any active or inactive ingredients of Faslodex (i.e. castor oil)
- Treatment with more than one regimen of chemotherapy for advanced breast cancer
- Treatment with more than one regimen of hormonal treatment for advanced breast cancer
Trial locations and contacts
106 sites in 17 countries.
106 sites in 17 countries
Russia16 sites
Research Site
Ivanovo, 153040
Research Site
Kazan, Tatarstan, 420029
Research Site
Kazan, Tatarstan, 420111
Research Site
Krasnodar, 350040
Research Site
Lipetsk, 398005
Research Site
Moscow, 107005
Research Site
Moscow, 115478
Research Site
Moscow, 121356
Research Site
Moscow, 59401
Research Site
Nizhny Novgorod, 603081
Research Site
Obninsk, 249020
Research Site
Ryazan, 390046
Research Site
Saint Petersburg, 191014
Research Site
Saint Petersburg, 197089
Research Site
Saint Petersburg, 197758
Research Site
Yaroslavl, 150054
United States14 sites
Research Site
Casa Grande, Arizona, 85122
Research Site
Crystal River, Florida, 34429
Research Site
Detroit, Michigan, 48202
Research Site
Fort Lauderdale, Florida, 33308
Research Site
Fountain Valley, California, 92708
Research Site
Greenville, North Carolina, 27858
Research Site
Kansas City, Missouri, 64131
Research Site
New Britain, Connecticut, 06052
Research Site
Pasadena, Texas, 77504
Research Site
Rosedale, Maryland, 21237
Research Site
St Louis, Missouri, 63141
Research Site
Urbana, Illinois, 61801
Research Site
Voorhees Township, New Jersey, 08043
Research Site
West Bend, Wisconsin, 53095
India11 sites
Research Site
Ansārinagar, 110 029
Research Site
Bhopal, 462001
Research Site
Hyderabad, 500082
Research Site
Jaipur, 302013
Research Site
Kolkata, 700054
Research Site
Manipal, 576 104
Research Site
Marg Jaipur, 302004
Research Site
Mumbai, 400012
Research Site
Pune, 411001
Research Site
Trivandrum, 2417
Research Site
Vellore, 632004
Belgium8 sites
Research Site
Brasschaat, 2930
Research Site
Brussels, 1070
Research Site
Brussels, 1090
Research Site
Edegem, 2650
Research Site
Ghent, 9000
Research Site
Hasselt, 3500
Research Site
Liège, 4000
Research Site
Turnhout, 2300
Czechia8 sites
Research Site
Brno, 656 53
Research Site
České Budějovice, 370 87
Research Site
Pardubice, 520 03
Research Site
Prague, 100 34
Research Site
Prague, 128 08
Research Site
Prague, 180 00
Research Site
Tábor, 390 03
Research Site
V Uvalu 84, 150 06
Ukraine8 sites
Research Site
Cherkasy, 18009
Research Site
Dnipro, 49102
Research Site
Donetsk, 83092
Research Site
Kyiv, 03022
Research Site
Lviv, 79031
Research Site
Sumy, 40022
Research Site
Ternopil, 46023
Research Site
Uzhhorod, 88000
Italy7 sites
Research Site
Aviano, 33081
Research Site
Bergamo, 24128
Research Site
Carpi, 41012
Research Site
Genova, 16132
Research Site
Prato, 59100
Research Site
Reggio Emilia, 42100
Research Site
Varese, 21100
Brazil6 sites
Research Site
Barretos, 14784-400
Research Site
Londrina, 86010-640
Research Site
Porto Alegre, 91350-200
Research Site
Recife, 50670-420
Research Site
Salvador, 40170-070
Research Site
São Paulo, 04039-001
Spain6 sites
Research Site
A Coruña, 15006
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Madrid, 28040
Research Site
Málaga, 29010
Research Site
Oviedo, 33011
Research Site
Salamanca, 37007
Research Site
Seville, 41013
Slovakia4 sites
Research Site
Bardejov, 08501
Research Site
Bratislava, 812 50
Research Site
Nitra, 949 01
Research Site
Trnava, 917 75
Chile3 sites
Research Site
Antofagasta, 1240000
Research Site
Santiago, 8380455
Research Site
Santiago
Hungary3 sites
Research Site
Nyíregyháza, 4400
Research Site
Székesfehérvár, 8000
Research Site
Szombathely, 9700
Mexico3 sites
Research Site
México, 01090
Research Site
México, 14140
Research Site
Mexico City, 06720
Poland3 sites
Research Site
Bialystok, 15-027
Research Site
Lodz, 90-553
Research Site
Poznan, 61-878
Venezuela3 sites
Research Site
Caracas, 1010
Research Site
Caracas, 1053
Research Site
Caracas, 1060
About this study
Official title: A Randomised, Double-Blind, Parallel-group, Multicentre, Phase III Study Comparing the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Fulvestrant (FASLODEX™) 250 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy
The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment.
- Conditions
- Breast Cancer
- Being tested
- Fulvestrant
- Keywords
- Advanced Breast Cancer, Metastatic Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FulvestrantDrug
Also called Faslodex, ZD9238
intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Fulvestrant 500 mg Receives: Drug: Fulvestrant |
| 2 | Experimental | Fulvestrant 250 mg Receives: Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Progression (TTP)
Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).
Measured: RECIST(Response Evaluation Criteria in Solid Tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
Secondary outcomes (7)
Objective Response Rate (ORR)
Using the RECIST scan data, an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR) which is subsequently confirmed as per RECIST. ORR is defined as the percentage of patients with OR.
Measured: RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
Clinical Benefit Rate (CBR)
A Clinical Benefit (CB) responder is defined as a patient having a best overall response of CR, PR or SD (stable disease) >=24 weeks. The Clinical Benefit Rate is the percentage of patients with CB.
Measured: Clinical Benefit from the sequence of RECIST scan data for study duration (48 months) . RECIST (Response Evaluation Criteria in Solid Tumours) scans were performed every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
Duration of Response (DoR)
Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR) or confirmed partial response (PR)
Measured: RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
Duration of Clinical Benefit (DoCB)
Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) >=24 weeks
Measured: RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
Overall Survival (OS)
Median time (in months) from randomisation until death (from any cause) (analysis at 50% deaths )
Measured: Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring for study duration (48 months)
Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study
Mean (and standard deviation) change from randomisation until treatment discontinuation in TOI (defined as the first visit response of 'worsened' which is a decrease in TOI from baseline of 5 points or more) using the Kaplan-Meier method. If a subject has not shown a reduction of 5 points or more at the time of analysis then the observation will be right censored using the last QOL assessment date. Trial Outcome Index (TOI) is derived from the FACT-B questionnaire (Cella et al, 1993) by adding together the scores from the following 3 subscales; Physical well-being (PWB), Functional well-being (FWB) and Breast cancer subscale (BCS). The TOI score range is 0-92 with the higher scores representing the more favourable outcomes. Data were collected from a subgroup of patients.
Measured: TOI questionnaires were completed every 4 weeks from randomisation until week 24 and then again at treatment discontinuation, for study duration (48 months)
Overall Survival (OS) - Follow-up
Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring during the study as a whole until the data cut-off for the survival extension (31st October 2011) are presented (analysis at 75% deaths)
Measured: Median time (in months) from randomisation until death (from any cause),up to 80 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2004 (estimated)
- Study start13 Feb 2005
- Primary completion27 Feb 2009
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 736 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Faslodex Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00099437
- Sponsor's protocol ID
- D6997C00002
- Other IDs
- 2004-002371-16, 2004
- Acronym
- CONFIRM
- Status last verified
- Sep 2026
- First submitted
- 13 Dec 2004
- Last updated
- 14 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Publications
Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.
PubMed 29522361