Clinical trial NCT00099437: 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.
Official title: A Randomised, Double-Blind, Parallel-group, Multicentre, Phase III Study Comparing the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Fulvestrant (FASLODEX™) 250 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Advanced Breast Cancer
Metastatic Breast Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2004-12-14
Enrollment: 736
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Time to Progression (TTP)
timeFrame: 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:
measure: Objective Response Rate (ORR)
timeFrame: RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
measure: Clinical Benefit Rate (CBR)
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)
measure: Duration of Response (DoR)
timeFrame: RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
measure: Duration of Clinical Benefit (DoCB)
timeFrame: RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
measure: Overall Survival (OS)
timeFrame: Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring for study duration (48 months)
measure: Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study
timeFrame: TOI questionnaires were completed every 4 weeks from randomisation until week 24 and then again at treatment discontinuation, for study duration (48 months)
measure: Overall Survival (OS) - Follow-up
timeFrame: Median time (in months) from randomisation until death (from any cause),up to 80 months
Other outcomes:
Locations:
city: Casa Grande
country: United States
facility: Research Site
state: Arizona
city: Fountain Valley
country: United States
facility: Research Site
state: California
city: New Britain
country: United States
facility: Research Site
state: Connecticut
city: Crystal River
country: United States
facility: Research Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Research Site
state: Florida
city: Urbana
country: United States
facility: Research Site
state: Illinois
city: Rosedale
country: United States
facility: Research Site
state: Maryland
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Kansas City
country: United States
facility: Research Site
state: Missouri
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Voorhees
country: United States
facility: Research Site
state: New Jersey
city: Greenville
country: United States
facility: Research Site
state: North Carolina
city: Pasadena
country: United States
facility: Research Site
state: Texas
city: West Bend
country: United States
facility: Research Site
state: Wisconsin
city: Brasschaat
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Edegem
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Hasselt
country: Belgium
facility: Research Site
city: Liège
country: Belgium
facility: Research Site
city: Turnhout
country: Belgium
facility: Research Site
city: Barretos
country: Brazil
facility: Research Site
city: Londrina
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Recife
country: Brazil
facility: Research Site
city: Salvador
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: Antofagasta
country: Chile
facility: Research Site
city: Santiago
country: Chile
facility: Research Site
city: Santiago
country: Chile
facility: Research Site
city: Bogota
country: Colombia
facility: Research Site
city: Cali
country: Colombia
facility: Research Site
city: Brno
country: Czechia
facility: Research Site
city: Ceske Budejovice
country: Czechia
facility: Research Site
city: Pardubice
country: Czechia
facility: Research Site
city: Praha 10
country: Czechia
facility: Research Site
city: Praha 2
country: Czechia
facility: Research Site
city: Praha 8
country: Czechia
facility: Research Site
city: Tabor
country: Czechia
facility: Research Site
city: V Uvalu 84
country: Czechia
facility: Research Site
city: Nyíregyháza
country: Hungary
facility: Research Site
city: Szombathely
country: Hungary
facility: Research Site
city: Székesfehérvár
country: Hungary
facility: Research Site
city: Ansari Nagar
country: India
facility: Research Site
city: Bhopal
country: India
facility: Research Site
city: Hyderabad
country: India
facility: Research Site
city: Jaipur
country: India
facility: Research Site
city: Kolkata
country: India
facility: Research Site
city: Manipal
country: India
facility: Research Site
city: Marg Jaipur
country: India
facility: Research Site
city: Mumbai
country: India
facility: Research Site
city: Pune
country: India
facility: Research Site
city: Trivandrum
country: India
facility: Research Site
city: Vellore
country: India
facility: Research Site
city: Aviano
country: Italy
facility: Research Site
city: Bergamo
country: Italy
facility: Research Site
city: Carpi
country: Italy
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: Prato
country: Italy
facility: Research Site
city: Reggio Emilia
country: Italy
facility: Research Site
city: Varese
country: Italy
facility: Research Site
city: Floriana
country: Malta
facility: Research Site
city: Mexico City
country: Mexico
facility: Research Site
city: Mexico
country: Mexico
facility: Research Site
city: Mexico
country: Mexico
facility: Research Site
city: Białystok
country: Poland
facility: Research Site
city: Poznań
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Ivanovo
country: Russian Federation
facility: Research Site
city: Kazan, Tatarstan
country: Russian Federation
facility: Research Site
city: Kazan, Tatarstan
country: Russian Federation
facility: Research Site
city: Krasnodar
country: Russian Federation
facility: Research Site
city: Lipetsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Nizhniy Novgorod
country: Russian Federation
facility: Research Site
city: Obninsk
country: Russian Federation
facility: Research Site
city: Ryazan
country: Russian Federation
facility: Research Site
city: St-Petersburg
country: Russian Federation
facility: Research Site
city: St.-Petersburg
country: Russian Federation
facility: Research Site
city: St.Petersburg
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Bardejov
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Nitra
country: Slovakia
facility: Research Site
city: Trnava
country: Slovakia
facility: Research Site
city: A Coruña
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Oviedo
country: Spain
facility: Research Site
city: Salamanca
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Cherkasy
country: Ukraine
facility: Research Site
city: Dnipro
country: Ukraine
facility: Research Site
city: Donetsk
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Lviv
country: Ukraine
facility: Research Site
city: Sumy
country: Ukraine
facility: Research Site
city: Ternopil
country: Ukraine
facility: Research Site
city: Uzhhorod
country: Ukraine
facility: Research Site
city: Caracas
country: Venezuela
facility: Research Site
city: Caracas
country: Venezuela
facility: Research Site
city: Caracas
country: Venezuela
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Faslodex Medical Science Director, MD
role: STUDY_DIRECTOR
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.