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A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer.

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hormone Receptor Positive Breast Cancer

Intervention: faslodex 500mg (Drug); arimidex 1mg (Drug); faslodex dummy (Drug); arimidex dummy (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Yuri E Rukazenkov, MD, Study Director, Affiliation: AstraZeneca
John Robertson, MD, Principal Investigator, Affiliation: Graduate Medicine and Health School, University of Nottingham, UK
Matthew Ellis, DM, Principal Investigator, Affiliation: Washington University School of Medicine, USA

Summary

The purpose of the study is to compare how treatment with Fulvestrant (FASLODEX) or Anastrozole (ARIMIDEX) effects disease progression for women with locally advanced or metastatic breast cancer who have not had prior hormonal treatment.

Clinical Details

Official title: A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg With Anastrozole (ARIMIDEX) 1 mg as Hormonal Treatment for Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal Therapy.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Compare the progression free survival (PFS) in patients treated with Fulvestrant with those treated with Anastrozole.

Secondary outcome:

Compare the Overall Survival (OS, death due to any cause) in patients treated with Fulvestrant with those treated with Anastrozole when 50% of patients are recorded as having died.

Measure objective response rate (ORR) for Fulvestrant treatment versus Anastrozole. (ORR =% of patients recording partial (PR) or complete response (CR).

Measure the duration of response (DoR) for Fulvestrant versus Anastrozole treatment. (DoR = days from PR/CR response to objective disease progression).

Measure expected duration of response (EDoR) for Fulvestrant treatment versus Anastrozole. (EDoR = p Efp(x), where x=DoR, p=proportion of responders, Efp(x) is mean duration of response).

Measure clinical benefit rate (CBR) for Fulvestrant treatment versus Anastrozole. (CBR= proportion of patients recording RECIST assessments of CR/PR or stable disease (SD) over at least 154 days.

Measure the duration of clinical benefit (DoCB) for Fulvestrant versus Anastrozole treatment. (DoCB = for patients recording clinical benefit responses only; days from randomization to date of disease progression).

Measure expected duration of clinical benefit (EDoCB) for Fulvestrant treatment versus Anastrozole. (EDoCB = p Efp(x), where x=DoCB, p=proportion of responders, Efp(x) is mean duration of clinical benefit).

Compare the effect of Fulvestrant treatment versus Anastrozole treatment on Health Related Quality of Life (HRQoL).

Compare the safety of fulvestrant versus anastrozole treatment by assessing adverse events and vital sign measurements: weight, pulse and blood pressure.

Compare the safety of fulvestrant versus anastrozole treatment by assessing a panel of adverse events measures: electrocardiogram, haematology and clinical chemistry assessments.

Compare the safety of fulvestrant versus anastrozole treatment after the primary analysis by continued collection and evaluation of serious adverse events.

Detailed description: A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg with Anastrozole (ARIMIDEX) 1 mg as Hormonal Treatment for Postmenopausal Women with Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal Therapy.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Histological confirmation of breast cancer in post menopausal women (age >=60).

Positive hormone receptor status (ER +ve and/or PgR +ve) of primary or metastatic tumour tissue based on local laboratory assessment.

- EITHER locally advanced disease (1 line of chemotherapy allowed only if remain

unsuitable for therapy of curative intent) OR Metastatic disease. (1 line of chemotherapy for breast cancer allowed only if subsequent evidence of further progressive disease)

- At least 1 lesion (measurable and/or non-measurable) that can be accurately assessed

at baseline and is suitable for repeated assessment.

- Postmenopausal women, fulfilling 1 of:

- Prior bilateral oophorectomy

- Age >60 years

- Age < 60 years and amenorrheic for 12+months in the absence of chemotherapy,

tamoxifen, toremifene, or ovarian suppression and FSH and oestradiol in the postmenopausal range Exclusion Criteria:

- Presence of life-threatening metastatic disease

- Any of:

- Extensive hepatic involvement

- involving brain or meninges

- symptomatic pulmonary lymph spread

- Discrete lung metastases are acceptable if respiratory function is not significantly

compromised

- Prior systemic therapy for breast cancer other than one line of cytotoxic

chemotherapy (the last dose of chemotherapy must have been received more than 28 days prior to randomisation)

- Radiation therapy if not completed within 28 days prior to randomisation (with the

exception of radiotherapy given for control of bone pain, started prior to randomisation). Prior hormonal treatment for breast cancer.

- Current or prior malignancy within previous 3 years (other than breast cancer or

adequately treated basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix).

Locations and Contacts

Research Site, La Rioja, Argentina

Research Site, Mar del Plata, Argentina

Research Site, Pergamino, Argentina

Research Site, Rosario, Argentina

Research Site, Porto Alegre, Brazil

Research Site, Santo André, Brazil

Research Site, Montreal, Canada

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Research Site, Guangzhou, China

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Research Site, Shenyang, China

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Research Site, Praha 5, Czech Republic

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Additional Information

Starting date: October 2012
Last updated: March 11, 2015

Page last updated: August 20, 2015

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