Overview

This trial is active, not recruiting.

Condition hormone receptor positive breast cancer
Treatments faslodex 500mg, arimidex 1mg, faslodex dummy, arimidex dummy
Phase phase 3
Sponsor AstraZeneca
Start date October 2012
End date April 2016
Trial size 524 participants
Trial identifier NCT01602380, D699BC00001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Blinded: Fulvestrant 500mg intramuscular injection (2x250mg) plus dummy Anastrozole tablets
faslodex 500mg
2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter
arimidex dummy
oral tablet 1 daily
(Active Comparator)
Blinded: Anastrozole 1mg tablets plus dummy Fulvestrant intramuscular injection (2x0mg)
arimidex 1mg
oral tablet 1 daily
faslodex dummy
2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter

Primary Outcomes

Measure
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.

Secondary Outcomes

Measure
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; cut off is expected in III quarter of 2017
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 until disease progression or treatment discontinuation. Then during survival follow up every 12 months until treatment discontinuation.
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 until disease progression or treatment discontinuation. Then during survival follow up every 12 months until treatment discontinuation.
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 until disease progression or treatment discontinuation. Then during survival follow up every 12 months until treatment discontinuation.
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 until disease progression or treatment discontinuation. Then during survival follow up every 12 months until treatment discontinuation.
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 until disease progression or treatment discontinuation. Then during survival follow up every 12 months until treatment discontinuation.
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 until disease progression or treatment discontinuation. Then during survival follow up every 12 months until treatment discontinuation.
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
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
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.
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.

Eligibility Criteria

Female participants from 18 years up to 130 years old.

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).

Additional Information

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.
Principal investigator John Robertson, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.