TriangleNCT00635713 · CITED IN SOURCE DOCUMENTS
Second Line Breast Cancer Trial
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
- 2009-04-10
The main purpose of this study is to compare the effect of 2 doses of FASLODEX with 1 dose of ARIMIDEX in terms of time to tumor progression in postmenopausal women with advanced 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.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility Criteria
- Inclusion Criteria: * postmenopausal women with confirmation of breast cancer * objective evidence of recurrence or progression of breast cancer no more than 1 prior hormonal therapy for breast cancer Exclusion Criteria: * presence of life-threatening metastatic visceral disease * previous treatment with FASLODEX, ARIMIDEX or any aromatase inhibitor for breast cancer * more than 1 prior endocrine medical treatment for advanced breast cancer .
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- FEMALE
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Faslodex 125mg and Arimidex 1 mg
- intervention Names
- Drug: Fulvestrant
- Drug: Anastrozole
- label
- 1
- type
- EXPERIMENTAL
- description
- Faslodex 250mg and Arimidex 1mg
- intervention Names
- Drug: Anastrozole
- Drug: Fulvestrant
- label
- 2
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- 1
- description
- 125mg
- name
- Fulvestrant
- other Names
- Faslodex
- type
- DRUG
- arm Group Labels
- 1
- 2
- description
- ARIMIDEX
- name
- Anastrozole
- type
- DRUG
- arm Group Labels
- 2
- description
- 250mg
- name
- Fulvestrant
- other Names
- Faslodex
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- DOUBLE
- primary Purpose
- TREATMENT
Enrollment
- count
- 588
- type
- ESTIMATED
Registered outcome plans (not posted results)
- primary Outcomes
- measure
- time to tumor progression
- time Frame
- Every 3 months
- secondary Outcomes
- measure
- objective tumor response
- time Frame
- Every 3 months
- measure
- time to treatment failure
- time Frame
- Every 3 months
- measure
- time to death
- time Frame
- Every 3 months
Full study description
- brief Summary
- The main purpose of this study is to compare the effect of 2 doses of FASLODEX with 1 dose of ARIMIDEX in terms of time to tumor progression in postmenopausal women with advanced breast cancer.
Source references
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-1295c3ffe9fd169faccc
- requested nct id
- NCT00635713
- primary nct id
- NCT00635713
- source kind
- fda_spl_label
- source record id
- 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
- source file sha256
- 424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
- payload sha256
- 62810fc2550f4d300045c39f58599f9c94660e6cba3cdd57cf264f229d85ba4f
- payload
- application numbers
- NDA021344
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-1295c3ffe9fd169faccc
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT00635713
- occurrences
- context exact
- ished by comparison to the selective aromatase inhibitor anastrozole in two randomized, controlled clinical trials (one conducted in North America, Study 0021, NCT00635713; the other predominantly in Europe, Study 0020) in postmenopausal women with locally advanced or metastatic breast cancer. All patients had progressed after pr
- end
- 6453
- exact text
- NCT00635713
- start
- 6442
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00500.json
- source file sha256
- 424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
- source json pointer
- /results/47/clinical_studies/0
- source kind
- fda_spl_label
- source record id
- 9541dd80-09f9-4d3c-bb2a-fc354e198a2e
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- cdde2914473c48e33fa5ddb3dbfa22c651ca0bd542fc87b6d73793b3f907e74c
- spl effective time
- 20200925
- spl set id
- 83d7a440-e904-4e36-afb5-cb02b1c919f7
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-6fa207cd87e5e108fddb
- requested nct id
- NCT00635713
- primary nct id
- NCT00635713
- source kind
- fda_spl_label
- source record id
- 29f2a48e-b9af-486e-bc0c-eab3a1ce0b3c
- source file sha256
- fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
- payload sha256
- bb90058ab1cc24d6abb9c4919d6c3c2412dcc84f2e1999bebad67914ec9e8568
- payload
- application numbers
- NDA210063
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-6fa207cd87e5e108fddb
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT00635713
- occurrences
- context exact
- ished by comparison to the selective aromatase inhibitor anastrozole in two randomized, controlled clinical trials (one conducted in North America, Study 0021, NCT00635713; the other predominantly in Europe, Study 0020) in postmenopausal women with locally advanced or metastatic breast cancer. All patients had progressed after pr
- end
- 6606
- exact text
- NCT00635713
- start
- 6595
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00100.json
- source file sha256
- fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
- source json pointer
- /results/53/clinical_studies/0
- source kind
- fda_spl_label
- source record id
- 29f2a48e-b9af-486e-bc0c-eab3a1ce0b3c
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- e227d6c42ab921a450a86a626d97a911eb7620ba99068fdf82a880a6e7ae7f12
- spl effective time
- 20260624
- spl set id
- e20d8ca3-8837-4003-8b01-1ebec342062a
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-91119926bd1ca3a75f94
- requested nct id
- NCT00635713
- primary nct id
- NCT00635713
- source kind
- fda_spl_label
- source record id
- c584c51e-3ce0-4682-a4dd-d0ac149201a8
- source file sha256
- a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
- payload sha256
- ee620ba8d05a7c2f50b5957ff806f7856743a1cd626fc04f4e587e08a95ee868
- payload
- application numbers
- NDA210326
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-91119926bd1ca3a75f94
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT00635713
- occurrences
- context exact
- ished by comparison to the selective aromatase inhibitor anastrozole in two randomized, controlled clinical trials (one conducted in North America, Study 0021, NCT00635713; the other predominantly in Europe, Study 0020) in postmenopausal women with locally advanced or metastatic breast cancer. All patients had progressed after pr
- end
- 6663
- exact text
- NCT00635713
- start
- 6652
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00600.json
- source file sha256
- a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
- source json pointer
- /results/57/clinical_studies/0
- source kind
- fda_spl_label
- source record id
- c584c51e-3ce0-4682-a4dd-d0ac149201a8
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- f1966f2ebe8f1f77795ede3763664849d851f6b174b9428129c2ee738d840c7b
- spl effective time
- 20240131
- spl set id
- fabe9bd8-ac23-4df1-a89a-223d5cd38914
Preserved source evidence · Not medical advice