A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg Plus 250mg Loading Regimen and 500mg

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00313170
• Date of registration: 10/04/2006
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg Plus 250mg Loading Regimen and 500mg FINDER II
• Scientific title: Phase II Study to Evaluate the Efficacy and Tolerability of Fulvestrant 250mg, 250mg Plus 250mg Loading Regimen and 500mg in Postmenopausal Women With ER +ve Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy
• Date of first enrolment: May 30, 2006
• Target sample size: 144
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00313170
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Belgium, Canada, Czech Republic, Czechia, France, Hungary, Poland, Romania, Turkey

Contacts

• Name: AstraZeneca Breast Cancer Established Brands Team Medical Science Director, MD
• Affiliation: AstraZeneca

Key inclusion & exclusion 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 (woman who has stopped having menstrual periods)

Exclusion Criteria:

- Treatment with more than one previous regimen of systemic anticancer therapy other
than endocrine therapy for advanced BC.

- Treatment with more than one previous regimen of endocrine therapy for advanced BC.

- An existing condition that prevents compliance.



Age minimum: 45 Years
Age maximum: 130 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Advanced Breast Cancer

Metastatic Breast Cancer

Intervention(s)

Drug: Fulvestrant

Primary Outcome(s)

Objective Response (ORR) [Time Frame: The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.]

Secondary Outcome(s)

Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body [Time Frame: Baseline to 12 weeks]

Pharmacokinetic Parameter: Mean Volume of Distribution at Steady State, a Measure of the Apparent Volume in the Body Into Which Fulvestrant Distributes [Time Frame: Baseline to 12 weeks]

Time to Progression (TTP) [Time Frame: The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.]

Clinical Benefit Rate (CBR) [Time Frame: The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.]

Duration of Response (DoR) [Time Frame: The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.]

Secondary ID(s)

FINDER II

D6997C00006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 29/08/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00313170