A Phase 3 interventional study of Fulvestrant in Breast Cancer, sponsored by AstraZeneca. Active, not recruiting at 106 sites in 17 countries. Open to female participants aged 45 Years to 130 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 736 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fulvestrant 500 mg
Drug: Fulvestrant
Fulvestrant 250 mg
Drug: Fulvestrant
intramuscular injection
Also known as: Faslodex, ZD9238
Time to Progression (TTP)
Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).
Time frame: RECIST(Response Evaluation Criteria in Solid Tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
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.
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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 )
Time frame: 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.
Time frame: 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)
Time frame: Median time (in months) from randomisation until death (from any cause),up to 80 months
| Milestone | Fulvestrant 250 mg | Fulvestrant 500 mg |
|---|---|---|
| Started | 374 | 362 |
| Completed | 8 | 13 |
| Not completed | 366 | 349 |
| Withdrew: Lost to follow-up | 30 | 33 |
| Withdrew: Death | 293 | 261 |
| Withdrew: Withdrawal by subject | 6 | 10 |
| Withdrew: Ongoing in fu but not on treatment | 37 | 45 |
Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).
| months | Fulvestrant 250 mg | Fulvestrant 500 mg |
|---|---|---|
| Time to Progression (TTP) | 5.5 (0 to NA) | 6.5 (0 to NA) |
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.
| Percentage of patients | Fulvestrant 250 mg | Fulvestrant 500 mg |
|---|---|---|
| Objective Response Rate (ORR) | 14.6 | 13.8 |
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.
| Percentage of patients | Fulvestrant 250 mg | Fulvestrant 500 mg |
|---|---|---|
| Clinical Benefit Rate (CBR) | 39.6 | 45.6 |
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)
| Time (in months) | Fulvestrant 250 mg | Fulvestrant 500 mg |
|---|---|---|
| Duration of Response (DoR) | 16.4 (3.7 to NA) | 19.4 (5.7 to NA) |
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
| Time (in months) | Fulvestrant 250 mg | Fulvestrant 500 mg |
|---|---|---|
| Duration of Clinical Benefit (DoCB) | 13.9 (3.7 to NA) | 16.6 (2.5 to NA) |
Median time (in months) from randomisation until death (from any cause) (analysis at 50% deaths )
| Time (in months) | Fulvestrant 250 mg | Fulvestrant 500 mg |
|---|---|---|
| Overall Survival (OS) | 22.8 (0.2 to NA) | 25.1 (0.1 to NA) |
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.
| Scores on a scale | Fulvestrant 250 mg | Fulvestrant 500 mg |
|---|---|---|
| Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study | -5.9 ± 9.89 | -7.5 ± 13.72 |
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)
| months | Fulvestrant 250 mg | Fulvestrant 500 mg |
|---|---|---|
| Overall Survival (OS) - Follow-up | 22.3 (0.2 to NA) | 26.4 (0.1 to NA) |
Collected over SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fulvestrant 250 mg | — | 27/374 (7.2%) | 235/374 (62.8%) |
| Fulvestrant 500 mg | — | 35/361 (9.7%) | 241/361 (66.8%) |
| Event | Fulvestrant 250 mg | Fulvestrant 500 mg |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 1/374 | 3/361 |
| VomitingGastrointestinal disorders | 1/374 | 3/361 |
| BronchitisInfections and infestations | 0/374 | 2/361 |
| PneumoniaInfections and infestations | 0/374 | 2/361 |
| HyperglycaemiaMetabolism and nutrition disorders | 0/374 | 2/361 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/374 | 2/361 |
| Acute Myocardial InfarctionCardiac disorders | 2/374 | 0/361 |
| Femur FractureInjury, poisoning and procedural complications | 2/374 | 1/361 |
| NeutropeniaBlood and lymphatic system disorders | 0/374 | 1/361 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/374 | 1/361 |
| Event | Fulvestrant 250 mg | Fulvestrant 500 mg |
|---|---|---|
| NauseaGastrointestinal disorders | 51/374 | 35/361 |
| Injection Site PainGastrointestinal disorders | 34/374 | 42/361 |
| Back PainMusculoskeletal and connective tissue disorders | 40/374 | 26/361 |
| Bone PainMusculoskeletal and connective tissue disorders | 28/374 | 34/361 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 29/374 | 29/361 |
| HeadacheNervous system disorders | 25/374 | 28/361 |
| FatigueGastrointestinal disorders | 24/374 | 27/361 |
| Pain In ExtremityMusculoskeletal and connective tissue disorders | 26/374 | 25/361 |
| Hot FlushVascular disorders | 22/374 | 24/361 |
| AstheniaGastrointestinal disorders | 23/374 | 21/361 |
| Age, Continuous(Years) | Fulvestrant 250 mg | Fulvestrant 500 mg | Total |
|---|---|---|---|
| Mean | 60.8 ± 11.94 | 61.0 ± 11.47 | 60.9 ± 11.71 |
| Sex: Female, Male(Participants) | Fulvestrant 250 mg | Fulvestrant 500 mg | Total |
|---|---|---|---|
| Female | 374 | 362 | 736 |
| Male | 0 | 0 | 0 |
Showing the first 100 of 106 sites across 17 countries. Choose a country and city above to see the rest.
Plan to share: 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
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com
Ran from Feb 2005 to primary completion in Feb 2009, 48 months.
Results were first posted in Jun 2010, 1 year 3 months after primary completion.
Of 272 industry-sponsored phase 3 interventional studies under Breast Neoplasms, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 63. This study's 48 months is above that.
Counting every sponsor, half of 600 studies reached it within 59 months; a quarter within 36 and three quarters within 96.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Fulvestrant