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

Purpose

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.

Condition	Intervention	Phase
Hormone Receptor Positive Breast Cancer	Drug: faslodex 500mg Drug: arimidex 1mg Drug: faslodex dummy Drug: arimidex dummy	Phase 3

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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Anastrozole Fulvestrant

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Compare the progression free survival (PFS) in patients treated with Fulvestrant with those treated with Anastrozole. [ Time Frame: Baseline RECIST 1.1 assessments and then every 12 weeks until the earliest of disease progression evident, patient dies or has surgery/radiotherapy for their disease. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: Following disease progression, patients will be contacted at 12 weekly intervals to determine survival status ] [ Designated as safety issue: No ]
Measure objective response rate (ORR) for Fulvestrant treatment versus Anastrozole. (ORR =% of patients recording partial (PR) or complete response (CR). [ Time Frame: Baseline RECIST 1.1 assessments and then every 12 weeks ] [ Designated as safety issue: No ]
Measure the duration of response (DoR) for Fulvestrant versus Anastrozole treatment. (DoR = days from PR/CR response to objective disease progression). [ Time Frame: Baseline RECIST 1.1 assessments and then every 12 weeks ] [ Designated as safety issue: No ]
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). [ Time Frame: Baseline RECIST 1.1 assessments and then every 12 weeks ] [ Designated as safety issue: No ]
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. [ Time Frame: Baseline RECIST 1.1 assessments and then every 12 weeks ] [ Designated as safety issue: No ]
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). [ Time Frame: Baseline RECIST 1.1 assessments and then every 12 weeks ] [ Designated as safety issue: No ]
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). [ Time Frame: Baseline RECIST 1.1 assessments and then every 12 weeks ] [ Designated as safety issue: No ]
Compare the effect of Fulvestrant treatment versus Anastrozole treatment on Health Related Quality of Life (HRQoL). [ Time Frame: Quality of life questionnaires completed at baseline, 12 weekly whilst on treatment, or 24 weekly for patients being followed for survival ] [ Designated as safety issue: No ]
Compare the safety of fulvestrant versus anastrozole treatment by assessing adverse events and vital sign measurements: weight, pulse and blood pressure. [ Time Frame: Up to the primary analysis: Adverse events will be collected from date of consent to 56 days after final injection. Vital signs will be collected at each on-treatment visit and until 35 days after last injection ] [ Designated as safety issue: Yes ]
Compare the safety of fulvestrant versus anastrozole treatment by assessing a panel of adverse events measures: electrocardiogram, haematology and clinical chemistry assessments. [ Time Frame: Up to the primary analysis: ECGs, clinical chemistry and haematology will be collected from randomization and every 12 weeks until 35 days after final injection. ] [ Designated as safety issue: Yes ]
Compare the safety of fulvestrant versus anastrozole treatment after the primary analysis by continued collection and evaluation of serious adverse events. [ Time Frame: Following the primary analysis, only serious adverse events are recorded up until 56 days after a patient's final injection. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	450
Study Start Date:	October 2012
Estimated Study Completion Date:	September 2017
Estimated Primary Completion Date:	April 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: faslodex+placebo Blinded: Fulvestrant 500mg intramuscular injection (2x250mg) plus dummy Anastrozole tablets	Drug: faslodex 500mg 2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter Drug: arimidex dummy oral tablet 1 daily
Active Comparator: arimidex +placebo Blinded: Anastrozole 1mg tablets plus dummy Fulvestrant intramuscular injection (2x0mg)	Drug: arimidex 1mg oral tablet 1 daily Drug: faslodex dummy 2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter

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

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01602380

Contacts

Contact: AstraZeneca Cancer Study Locator Service	877-400-4656	astrazeneca@emergingmed.com
Contact: Michala Worrell	+44 (0) 1530 519421	michala.worrell@quintiles.com

Show 149 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Yuri E Rukazenkov, MD	AstraZeneca
Principal Investigator:	John Robertson, MD	Graduate Medicine and Health School, University of Nottingham, UK
Principal Investigator:	Matthew Ellis, DM	Washington University School of Medicine, USA

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01602380 History of Changes
Other Study ID Numbers:	D699BC00001
Study First Received:	May 11, 2012
Last Updated:	March 1, 2013
Health Authority:	Argentina: Human Research Bioethics Committee Argentina: Ministry of Health Brazil: Ministry of Health Brazil: Ethics Committee Canada: Ethics Review Committee Canada: Health Canada China: Food and Drug Administration China: Ministry of Health China: National Natural Science Foundation Czech Republic: State Institute for Drug Control Czech Republic: Ethics Committee India: Drugs Controller General of India India: Institutional Review Board Italy: Ethics Committee Italy: Ministry of Health Japan: Pharmaceuticals and Medical Devices Agency Mexico: Ethics Committee Mexico: Ministry of Health Peru: General Directorate of Pharmaceuticals, Devices, and Drugs Peru: Ministry of Health Poland: Ethics Committee Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products ROMANIA: The National Board of Ethics for the Clinical Study of Medicines Romania: National Agency for Medicines and Medical Devices Russia: FSI Scientific Center of Expertise of Medical Application Russia: Ministry of Health of the Russian Federation Russia: Ethics Committee Russia: Pharmacological Committee, Ministry of Health Slovakia: State Institute for Drug Control Slovenia: Ethics Committee South Africa: Medicines Control Council Spain: Spanish Agency of Medicines Taiwan: Institutional Review Board Taiwan: Department of Health Turkey: Ethics Committee Turkey: Ministry of Health Ukraine: Ministry of Health Ukraine: State Pharmacological Center - Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: Research Ethics Committee United States: Food and Drug Administration

Keywords provided by AstraZeneca:

hormone receptor positive breast cancer
endocrine
no hormone therapy
hormone
breast

cancer
neoplasm
metastatic
tumour

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Anastrozole
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013

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