Trial Outcomes & Findings for 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. (NCT NCT00099437)

Last Updated: 2025-09-24

Results Overview

Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

736 participants

Primary outcome timeframe

RECIST(Response Evaluation Criteria in Solid Tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)

Results posted on

2025-09-24

Participant Flow

Participant milestones

Participant milestones
Measure	Fulvestrant 250 mg Fulvestrant 250 mg Intramuscular Injection every 28 days	Fulvestrant 500 mg Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
Overall Study STARTED	374	362
Overall Study COMPLETED	8	13
Overall Study NOT COMPLETED	366	349

Reasons for withdrawal

Reasons for withdrawal
Measure	Fulvestrant 250 mg Fulvestrant 250 mg Intramuscular Injection every 28 days	Fulvestrant 500 mg Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
Overall Study Lost to Follow-up	30	33
Overall Study Death	293	261
Overall Study Withdrawal by Subject	6	10
Overall Study Ongoing in FU but not on treatment	37	45

Baseline Characteristics

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.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fulvestrant 250 mg n=374 Participants Fulvestrant 250 mg Intramuscular Injection every 28 days	Fulvestrant 500 mg n=362 Participants Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14	Total n=736 Participants Total of all reporting groups
Age, Continuous	60.8 Years STANDARD_DEVIATION 11.94 • n=5 Participants	61.0 Years STANDARD_DEVIATION 11.47 • n=7 Participants	60.9 Years STANDARD_DEVIATION 11.71 • n=5 Participants
Sex: Female, Male Female	374 Participants n=5 Participants	362 Participants n=7 Participants	736 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: RECIST(Response Evaluation Criteria in Solid Tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)

Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).

Outcome measures

Outcome measures
Measure	Fulvestrant 250 mg n=374 Participants Fulvestrant 250 mg Intramuscular Injection every 28 days	Fulvestrant 500 mg n=362 Participants Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
Time to Progression (TTP)	5.5 months Interval 0.0 to Not Applicable - not all participants had an event at time of analysis, max time censored	6.5 months Interval 0.0 to Not Applicable - not all participants had an event at time of analysis, max time censored

SECONDARY outcome

Timeframe: RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)

Population: All patients with measurable disease at baseline.

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.

Outcome measures

Outcome measures
Measure	Fulvestrant 250 mg n=261 Participants Fulvestrant 250 mg Intramuscular Injection every 28 days	Fulvestrant 500 mg n=240 Participants Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
Objective Response Rate (ORR)	14.6 Percentage of patients	13.8 Percentage of patients

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure	Fulvestrant 250 mg n=374 Participants Fulvestrant 250 mg Intramuscular Injection every 28 days	Fulvestrant 500 mg n=362 Participants Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
Clinical Benefit Rate (CBR)	39.6 Percentage of patients	45.6 Percentage of patients

SECONDARY outcome

Timeframe: RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)

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)

Outcome measures

Outcome measures
Measure	Fulvestrant 250 mg n=38 Participants Fulvestrant 250 mg Intramuscular Injection every 28 days	Fulvestrant 500 mg n=33 Participants Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
Duration of Response (DoR)	16.4 Time (in months) Interval 3.7 to Not Applicable - not all participants had an event at time of analysis, max time censored	19.4 Time (in months) Interval 5.7 to Not Applicable - not all participants had an event at time of analysis, max time censored

SECONDARY outcome

Timeframe: RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)

Outcome measures

Outcome measures
Measure	Fulvestrant 250 mg n=148 Participants Fulvestrant 250 mg Intramuscular Injection every 28 days	Fulvestrant 500 mg n=165 Participants Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
Duration of Clinical Benefit (DoCB)	13.9 Time (in months) Interval 3.7 to Not Applicable - not all participants had an event at time of analysis, max time censored	16.6 Time (in months) Interval 2.5 to Not Applicable - not all participants had an event at time of analysis, max time censored

SECONDARY outcome

Timeframe: Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring for study duration (48 months)

Population: All patients with measurable disease at baseline.

Median time (in months) from randomisation until death (from any cause) (analysis at 50% deaths )

Outcome measures

Outcome measures
Measure	Fulvestrant 250 mg n=374 Participants Fulvestrant 250 mg Intramuscular Injection every 28 days	Fulvestrant 500 mg n=362 Participants Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
Overall Survival (OS)	22.8 Time (in months) Interval 0.2 to Not Applicable - not all participants had an event at time of analysis, max time censored	25.1 Time (in months) Interval 0.1 to Not Applicable - not all participants had an event at time of analysis, max time censored

SECONDARY outcome

Timeframe: TOI questionnaires were completed every 4 weeks from randomisation until week 24 and then again at treatment discontinuation, for study duration (48 months)

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.

Outcome measures

Outcome measures
Measure	Fulvestrant 250 mg n=35 Participants Fulvestrant 250 mg Intramuscular Injection every 28 days	Fulvestrant 500 mg n=34 Participants Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study	-5.9 Scores on a scale Standard Deviation 9.89	-7.5 Scores on a scale Standard Deviation 13.72

SECONDARY outcome

Timeframe: Median time (in months) from randomisation until death (from any cause),up to 80 months

Population: All randomised patients

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)

Outcome measures

Outcome measures
Measure	Fulvestrant 250 mg n=374 Participants Fulvestrant 250 mg Intramuscular Injection every 28 days	Fulvestrant 500 mg n=362 Participants Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
Overall Survival (OS) - Follow-up	22.3 months Interval 0.2 to Not Applicable - not all participants had an event at time of analysis, max time censored	26.4 months Interval 0.1 to Not Applicable - not all participants had an event at time of analysis, max time censored

Adverse Events

Fulvestrant 250 mg

Serious events: 27 serious events

Other events: 235 other events

Deaths: 0 deaths

Fulvestrant 500 mg

Serious events: 35 serious events

Other events: 241 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Fulvestrant 250 mg n=374 participants at risk Fulvestrant 250 mg Intramuscular Injection every 28 days	Fulvestrant 500 mg n=361 participants at risk Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
Gastrointestinal disorders Nausea	13.6% 51/374 • SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009 1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.	9.7% 35/361 • SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009 1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.
Gastrointestinal disorders Vomiting	5.3% 20/374 • SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009 1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.	5.8% 21/361 • SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009 1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.
Gastrointestinal disorders Injection Site Pain	9.1% 34/374 • SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009 1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.	11.6% 42/361 • SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009 1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.
Gastrointestinal disorders Fatigue	6.4% 24/374 • SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009 1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.	7.5% 27/361 • SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009 1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.
Gastrointestinal disorders Asthenia	6.1% 23/374 • SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009 1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.	5.8% 21/361 • SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009 1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.
Metabolism and nutrition disorders Anorexia	3.7% 14/374 • SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009 1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.	6.1% 22/361 • SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009 1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.
Musculoskeletal and connective tissue disorders Back Pain	10.7% 40/374 • SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009 1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.	7.2% 26/361 • SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009 1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.
Musculoskeletal and connective tissue disorders Bone Pain	7.5% 28/374 • SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009 1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.	9.4% 34/361 • SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009 1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.
Musculoskeletal and connective tissue disorders Arthralgia	7.8% 29/374 • SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009 1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.	8.0% 29/361 • SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009 1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.
Musculoskeletal and connective tissue disorders Pain In Extremity	7.0% 26/374 • SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009 1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.	6.9% 25/361 • SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009 1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	3.2% 12/374 • SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009 1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.	5.5% 20/361 • SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009 1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.
Nervous system disorders Headache	6.7% 25/374 • SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009 1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.	7.8% 28/361 • SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009 1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.
Respiratory, thoracic and mediastinal disorders Cough	5.3% 20/374 • SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009 1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.	5.3% 19/361 • SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009 1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.
Vascular disorders Hot Flush	5.9% 22/374 • SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009 1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.	6.6% 24/361 • SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009 1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.

Additional Information

Gerard Lynch

AstraZeneca

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that they cannot publish any information to do with the trial without written consent from Quintiles.
Publication restrictions are in place

Restriction type: OTHER