TriangleNCT00099437 · CITED IN SOURCE DOCUMENTS
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.
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- ACTIVE NOT RECRUITING
- Registry last update
- 2026-06-11
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Time to Progression (TTP)
Objective Response Rate (ORR)
Clinical Benefit Rate (CBR)
Duration of Response (DoR)
Duration of Clinical Benefit (DoCB)
Overall Survival (OS)
Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study
Overall Survival (OS) - Follow-up
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * 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 Exclusion Criteria: * 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
- healthy Volunteers
- false
- maximum Age
- 130 Years
- minimum Age
- 45 Years
- sex
- FEMALE
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Fulvestrant 500 mg
- intervention Names
- Drug: Fulvestrant
- label
- 1
- type
- EXPERIMENTAL
- description
- Fulvestrant 250 mg
- intervention Names
- Drug: Fulvestrant
- label
- 2
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- 1
- 2
- description
- intramuscular injection
- name
- Fulvestrant
- other Names
- Faslodex
- ZD9238
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- QUADRUPLE
- who Masked
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 736
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).
- measure
- Time to Progression (TTP)
- 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)
- secondary Outcomes
- description
- 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.
- measure
- Objective Response Rate (ORR)
- time Frame
- RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
- description
- 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.
- measure
- Clinical Benefit Rate (CBR)
- 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)
- description
- 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)
- measure
- Duration of Response (DoR)
- time Frame
- RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
- description
- 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
- measure
- Duration of Clinical Benefit (DoCB)
- time Frame
- RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
- description
- Median time (in months) from randomisation until death (from any cause) (analysis at 50% deaths )
- measure
- Overall Survival (OS)
- time Frame
- Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring for study duration (48 months)
- description
- 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.
- measure
- Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study
- 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)
- description
- 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)
- measure
- Overall Survival (OS) - Follow-up
- time Frame
- Median time (in months) from randomisation until death (from any cause),up to 80 months
Full study description
- brief 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.
Source references
- references
- citation
- 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.
- pmid
- 29522361
- type
- DERIVED
- see Also Links
- label
- CSP-D6997C00002.PDF
- label
- D6997C00002 Study Report Synopsis
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice