Phase 3
Completed N=462
A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer.
Source: ClinicalTrials.gov NCT01602380 ↗Enrolled (actual)
462
Serious AEs
16.3%
Results posted
May 2017
Primary outcomePrimary: Comparison of Progression-Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole — 16.6; 13.8 Months — p=0.0486
◆ Published Evidence
Highly cited
602citations · ~60 / year
Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial.
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.
Linked Publications (4)
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Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial.
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Fulvestrant 500 mg Versus Anastrozole 1 mg for the First-Line Treatment of Advanced Breast Cancer: Overall Survival Analysis From the Phase II FIRST Study.
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Health-related quality of life from the FALCON phase III randomised trial of fulvestrant 500 mg versus anastrozole for hormone receptor-positive advanced breast cancer.
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Fulvestrant Versus Anastrozole in Endocrine Therapy-Naïve Women With Hormone Receptor-Positive Advanced Breast Cancer: Final Overall Survival in the Phase III FALCON Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Progression-Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole |
16.6; 13.8 | 0.0486 sig |
| SECONDARY Comparison of Overall Survival (OS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole; Percentage of Patients With Events |
68.3; 67.7 | 0.7579 |
| SECONDARY Objective Response Rate (ORR) for Fulvestrant Treatment Versus Anastrozole Treatment |
46.1; 44.9 | 0.7290 |
| SECONDARY Duration of Response (DoR) for Fulvestrant Treatment Versus Anastrozole Treatment |
20.0; 13.2 | — |
| SECONDARY Expected Duration of Response (EDoR) for Fulvestrant Treatment Versus Anastrozole Treatment |
346.84; 227.58 | 0.0367 sig |
| SECONDARY Clinical Benefit Rate (CBR) for Fulvestrant Treatment Versus Anastrozole Treatment |
78.3; 74.1 | 0.3045 |
| SECONDARY Duration of Clinical Benefit (DoCB) for Fulvestrant Treatment Versus Anastrozole Treatment |
22.1; 19.1 | — |
| SECONDARY Expected Duration of Clinical Benefit (EDoCB) for Fulvestrant Treatment Versus Anastrozole Treatment |
667.94; 532.04 | 0.0561 |
| SECONDARY Comparison of the Effect of Fulvestrant Treatment Versus Anastrozole Treatment on Time to Deterioration of Health-Related Quality of Life (HRQoL) |
14.1; 11.1; 13.8; 11.1 | 0.2846 |
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT01602380) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.