TriangleNCT00256698 · CITED IN SOURCE DOCUMENTS
Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination 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
- COMPLETED
- Registry last update
- 2012-08-01
The purpose of this study is to determine the efficacy of anastrozole monotherapy versus maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared with in treatment of hormone receptor positive women with first relapse of breast cancer.
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)
Percentage of Evaluable Participants With Objective Response Rate (ORR)
Percentage of Clinical Benefit Rate (CBR) Responders
Duration of Response (DoR)
Duration of Clinical Benefit (DoCB)
Time to Treatment Failure (TTF)
Overall Survival (OS)
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Signed informed consent, postmenopausal females, histological or cytological confirmed oestrogene and/or progesterone (PgR) receptor positive breast cancer, local recurrence or metastasis Exclusion Criteria: * Previous systemic endocrine therapy for advanced or recurrent disease; prior fulvestrant therapy * Premenopausal women
- healthy Volunteers
- false
- sex
- FEMALE
- std Ages
- CHILD
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Anastrozole
- intervention Names
- Drug: Anastrozole
- label
- 1
- type
- ACTIVE_COMPARATOR
- description
- Anastrozole + Fulvestrant
- intervention Names
- Drug: Fulvestrant
- Drug: Anastrozole
- label
- 2
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- 2
- description
- intramuscular injection 250 mg loading dose (LD) regimen
- name
- Fulvestrant
- other Names
- Faslodex
- ZD9238
- type
- DRUG
- arm Group Labels
- 1
- 2
- description
- 1 mg oral tablet
- name
- Anastrozole
- other Names
- Arimidex
- ZD1033
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 514
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- RECIST (Response Evaluation Criteria in Solid Tumours) assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009. TTP, time in months to worsen 'progression' according to RECIST criteria. (RECIST is a set of published rules that define when cancer patients improve "respond", stay the same "stable"or worsen "progression" during treatments.
- measure
- Time to Progression (TTP)
- time Frame
- RECIST assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
- secondary Outcomes
- description
- No. of patients who were objective responders over the no. of patients evaluable for response x100. An objective responder = a patient whose best response is either CR (disappearance of all lesions) or PR (\>= 30% shrinkage in the sum of the longest diamemeters of the measurable lesions + no new lesions + no progression of non-measurable lesions)
- measure
- Percentage of Evaluable Participants With Objective Response Rate (ORR)
- time Frame
- RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
- description
- No. of patients who were clinical benefit responders over the no. of randomised patients x100. A clinical benefit responder = a patient whose best response is CR, PR or SD\>=24 weeks (where a best response of SD = no new lesions and for existing lesions; neither suffient shrinkage to count as PR nor sufficient growth to count as progression)
- measure
- Percentage of Clinical Benefit Rate (CBR) Responders
- time Frame
- RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
- description
- Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are objective responders
- measure
- Duration of Response (DoR)
- time Frame
- RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
- description
- Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are clinical benefit responders
- measure
- Duration of Clinical Benefit (DoCB)
- time Frame
- RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
- description
- Time from randomisation until the date of discontinuation of randomised treatment for any reason
- measure
- Time to Treatment Failure (TTF)
- time Frame
- From randomisation until data cut-off on 30th April 2009
- description
- Overall survival is equivalent to time to death. Time from randomisation until the date of death
- measure
- Overall Survival (OS)
- time Frame
- All deaths occurring between randomisation and data cut-off on 30th April 2009 are included.
Full study description
- brief Summary
- The purpose of this study is to determine the efficacy of anastrozole monotherapy versus maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared with in treatment of hormone receptor positive women with first relapse of breast cancer.
Source references
Source notices and limitations
Discovery and provenance
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- occurrences
- context exact
- Group (SWOG) trial included more patients who presented with metastatic disease; the Fulvestrant and Anastrozole Combination Therapy (<a href="/clinicaltrials/NCT00256698">FACT</a> [NCT00256698]) study enrolled more patients who had previously received tamoxifen.[<a href="#cit/section_10.48">48</a>,<a href="#cit/section_10.49"
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- context exact
- uded more patients who presented with metastatic disease; the Fulvestrant and Anastrozole Combination Therapy (<a href="/clinicaltrials/NCT00256698">FACT</a> [NCT00256698]) study enrolled more patients who had previously received tamoxifen.[<a href="#cit/section_10.48">48</a>,<a href="#cit/section_10.49">49</a>]</p> <
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- source retrieved at
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- source title
- Breast Cancer Treatment (PDQ®)–Health Professional Version
- source update dates
- context
- Updated: April 25, 2025
- datetime
- 2025-04-25T12:00:00Z
- display
- April 25, 2025
Preserved source evidence · Not medical advice