Clinical Trials List
Protocol NumberD699BC00001
2012-11-01 - 2018-01-31
Phase III
Terminated5
A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEXTM) 500 mg with Anastrozole (ARIMIDEXTM) 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 (FALCON)
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
AstraZeneca
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 金光亮 Division of General Surgery
- Chun-Yu Liu Division of General Surgery
- Ta-Chung Chao Division of General Surgery
- Yi-Fang Tsai Division of General Surgery
- 邱仁輝 Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 吳志雄 Division of Hematology & Oncology
- 林漢斌 Division of Hematology & Oncology
- 蘇智銘 Division of Hematology & Oncology
- CHIH-MING SU 未分科
- Tsu-Yi Chao Division of Hematology & Oncology
- 謝耀宇 Division of Hematology & Oncology
- 蘇勇誠 Division of Hematology & Oncology
- 林漢枏 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- HWEI-CHUNG WANG Division of General Surgery
- 葉名焮 Division of General Surgery
- Chih-Jung Chen Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Breast Cancer
Objectives
To demonstrate the superior progression-free survival (PFS) of patients treated with
fulvestrant 500 mg versus patients treated with anastrozole 1 mg.
Test Drug
FASLODEX
Active Ingredient
Fulvestrant
Dosage Form
Syringe
Dosage
250 mg/5ml
Endpoints
Primary:
To demonstrate the superior progression-free survival (PFS) of patients treated with
fulvestrant 500 mg versus patients treated with anastrozole 1 mg.
Secondary:
1. To compare the overall survival (OS) of patients treated with fulvestrant 500 mg
versus patients treated with anastrozole 1 mg.
2. To compare the objective response rate (ORR), duration of response (DoR) and the
expected duration of response (EDoR) of patients treated with fulvestrant 500 mg
versus patients treated with anastrozole 1 mg.
3. To compare the clinical benefit rate (CBR), the duration of clinical benefit (DoCB)
and the expected duration of clinical benefit (EDoCB) of patients treated with
fulvestrant 500 mg versus patients treated with anastrozole 1 mg.
4. To compare the quality of life (QoL) of patients treated with fulvestrant 500 mg
versus patients treated with anastrozole 1 mg.
5. To compare the safety and tolerability of fulvestrant 500 mg treatment versus that
of anastrozole 1 mg treatment.
Exploratory:
To explore how variations in tumour biomarkers (DNA, RNA and/or protein based) may be
related to factors that may influence development of cancer and/or study treatment response and resistance.
To demonstrate the superior progression-free survival (PFS) of patients treated with
fulvestrant 500 mg versus patients treated with anastrozole 1 mg.
Secondary:
1. To compare the overall survival (OS) of patients treated with fulvestrant 500 mg
versus patients treated with anastrozole 1 mg.
2. To compare the objective response rate (ORR), duration of response (DoR) and the
expected duration of response (EDoR) of patients treated with fulvestrant 500 mg
versus patients treated with anastrozole 1 mg.
3. To compare the clinical benefit rate (CBR), the duration of clinical benefit (DoCB)
and the expected duration of clinical benefit (EDoCB) of patients treated with
fulvestrant 500 mg versus patients treated with anastrozole 1 mg.
4. To compare the quality of life (QoL) of patients treated with fulvestrant 500 mg
versus patients treated with anastrozole 1 mg.
5. To compare the safety and tolerability of fulvestrant 500 mg treatment versus that
of anastrozole 1 mg treatment.
Exploratory:
To explore how variations in tumour biomarkers (DNA, RNA and/or protein based) may be
related to factors that may influence development of cancer and/or study treatment response and resistance.
Inclution Criteria
1. Provision of signed, written informed consent prior to any study specific
procedures.
2. Histological confirmation of breast cancer.
3. Positive hormone receptor status (ER +ve and/or PgR +ve) of primary or metastatic
tumour tissue based on local laboratory assessment.
4. Have EITHER
− locally advanced disease not amenable to surgery or radiotherapy of curative
intent. Patients may have had one line of cytotoxic chemotherapy, following
which they must remain unsuitable for therapy of curative intent.
OR
− metastatic disease
Patients may have received one line of cytotoxic chemotherapy as previous
treatment of breast cancer but must show progressive disease prior to enrolment.
5. At least 1 lesion (measurable and/or non-measurable) that can be accurately
assessed at baseline and is suitable for repeated assessment by CT, MRI or plain
x-ray.
6. Postmenopausal woman, defined as a woman fulfilling any 1 of the following
criteria (based on the NCCN definition of menopause
− Prior bilateral oophorectomy
− Age ≥60 years
− Age <60 years and amenorrheic for 12 or more months in the absence of
chemotherapy, tamoxifen, toremifene, or ovarian suppression and follicle
stimulating hormone and oestradiol in the postmenopausal range.
7. WHO performance status 0, 1 or 2.
For inclusion in the optional biomarker research component of this study, patients should
fulfil the following criterion:
• Provision of informed consent for biomarker research.
If a patient declines to participate in the biomarker research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent to the main protocol.
procedures.
2. Histological confirmation of breast cancer.
3. Positive hormone receptor status (ER +ve and/or PgR +ve) of primary or metastatic
tumour tissue based on local laboratory assessment.
4. Have EITHER
− locally advanced disease not amenable to surgery or radiotherapy of curative
intent. Patients may have had one line of cytotoxic chemotherapy, following
which they must remain unsuitable for therapy of curative intent.
OR
− metastatic disease
Patients may have received one line of cytotoxic chemotherapy as previous
treatment of breast cancer but must show progressive disease prior to enrolment.
5. At least 1 lesion (measurable and/or non-measurable) that can be accurately
assessed at baseline and is suitable for repeated assessment by CT, MRI or plain
x-ray.
6. Postmenopausal woman, defined as a woman fulfilling any 1 of the following
criteria (based on the NCCN definition of menopause
− Prior bilateral oophorectomy
− Age ≥60 years
− Age <60 years and amenorrheic for 12 or more months in the absence of
chemotherapy, tamoxifen, toremifene, or ovarian suppression and follicle
stimulating hormone and oestradiol in the postmenopausal range.
7. WHO performance status 0, 1 or 2.
For inclusion in the optional biomarker research component of this study, patients should
fulfil the following criterion:
• Provision of informed consent for biomarker research.
If a patient declines to participate in the biomarker research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent to the main protocol.
Exclusion Criteria
1. Presence of life-threatening metastatic visceral disease, defined as extensive hepatic
involvement, or any degree of brain or leptomeningeal involvement (past or
present), or symptomatic pulmonary lymphangitic spread. Patients with discrete
pulmonary parenchymal metastases are eligible, provided their respiratory function
is not significantly compromised as a result of disease in the opinion of the
investigator.
2. 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).
3. Radiation therapy if not completed within 28 days prior to randomisation (with the
exception of radiotherapy given for control of bone pain, which must be completed
prior to the day of randomisation, see Section 5.6).
4. Herceptin-eligible (HER2 overexpression or gene amplification,
ie, immunohistochemistry (IHC)3+ve or fluorescence in situ hybridisation
(FISH)+ve, where appropriate).
5. Prior treatment with a non-approved or experimental drug for breast cancer.
6. Concomitant anticancer treatment (with the exception of bisphosphonates, see
Section 5.6).
7. Prior hormonal treatment for breast cancer.
8. Prior treatment with systemic hormone replacement therapy.
9. Current or prior malignancy (other than breast cancer or adequately treated basal
cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix)
unless curatively treated with no evidence of disease within previous 5 years.
10. Any of the following laboratory values within 4 weeks of randomisation:
− Platelets <100 × 109/L
− Total bilirubin >1.5 × upper limit of reference range (ULRR) (Patients with
confirmed Gilbert’s syndrome may be included in the study)
− ALT or AST >2.5 × ULRR if no demonstrable liver metastases or >5 × ULRR
in presence of liver metastases.
11. History of:
− bleeding diathesis (ie, disseminated intravascular coagulation, clotting factor
deficiency) or
− long-term anticoagulant therapy (although patients treated with anti-platelet
therapy and low dose warfarin are eligible providing they have an international
normalised ratio [INR] of ≤1.6).
12. History of hypersensitivity to active or inactive excipients of FASLODEX™ or
ARIMIDEX™ or castor oil.
13. Any severe concomitant condition which makes it undesirable for the patient to
participate in the trial or which would jeopardise compliance with the study
protocol, eg, uncontrolled cardiac disease or uncontrolled diabetes mellitus.
14. Previous randomisation in the present study.
15. Involvement in the planning and/or conduct of the study (applies to AstraZeneca
staff, its agents, and/or staff at the study site).
16. Participation in a clinical study and/or receipt of an investigational drug within
28 days prior to randomisation (participation in the survival follow-up period of a
study is not an exclusion).
involvement, or any degree of brain or leptomeningeal involvement (past or
present), or symptomatic pulmonary lymphangitic spread. Patients with discrete
pulmonary parenchymal metastases are eligible, provided their respiratory function
is not significantly compromised as a result of disease in the opinion of the
investigator.
2. 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).
3. Radiation therapy if not completed within 28 days prior to randomisation (with the
exception of radiotherapy given for control of bone pain, which must be completed
prior to the day of randomisation, see Section 5.6).
4. Herceptin-eligible (HER2 overexpression or gene amplification,
ie, immunohistochemistry (IHC)3+ve or fluorescence in situ hybridisation
(FISH)+ve, where appropriate).
5. Prior treatment with a non-approved or experimental drug for breast cancer.
6. Concomitant anticancer treatment (with the exception of bisphosphonates, see
Section 5.6).
7. Prior hormonal treatment for breast cancer.
8. Prior treatment with systemic hormone replacement therapy.
9. Current or prior malignancy (other than breast cancer or adequately treated basal
cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix)
unless curatively treated with no evidence of disease within previous 5 years.
10. Any of the following laboratory values within 4 weeks of randomisation:
− Platelets <100 × 109/L
− Total bilirubin >1.5 × upper limit of reference range (ULRR) (Patients with
confirmed Gilbert’s syndrome may be included in the study)
− ALT or AST >2.5 × ULRR if no demonstrable liver metastases or >5 × ULRR
in presence of liver metastases.
11. History of:
− bleeding diathesis (ie, disseminated intravascular coagulation, clotting factor
deficiency) or
− long-term anticoagulant therapy (although patients treated with anti-platelet
therapy and low dose warfarin are eligible providing they have an international
normalised ratio [INR] of ≤1.6).
12. History of hypersensitivity to active or inactive excipients of FASLODEX™ or
ARIMIDEX™ or castor oil.
13. Any severe concomitant condition which makes it undesirable for the patient to
participate in the trial or which would jeopardise compliance with the study
protocol, eg, uncontrolled cardiac disease or uncontrolled diabetes mellitus.
14. Previous randomisation in the present study.
15. Involvement in the planning and/or conduct of the study (applies to AstraZeneca
staff, its agents, and/or staff at the study site).
16. Participation in a clinical study and/or receipt of an investigational drug within
28 days prior to randomisation (participation in the survival follow-up period of a
study is not an exclusion).
The Estimated Number of Participants
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Taiwan
11 participants
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Global
450 participants
