Phase 3
N=698
Study of Faslodex +/- Concomitant Arimidex v Exemestane Following Progression on Non-steroidal Aromatase Inhibitors
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00253422 ↗Enrolled (actual)
698
Serious AEs
15.4%
Results posted
Jun 2025
Primary outcome: Primary: Progression-free Survival — 4.8; 4.1; 3.5 Months — p=0.76
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Anastrozole (Drug); Exemestane (Drug); Fulvestrant (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Institute of Cancer Research, United Kingdom
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
4.8; 4.1; 3.5 | 0.76 |
| SECONDARY Objective Response Rate |
16; 17; 10 | 0.99 |
| SECONDARY Duration of Response |
10.2; 8.7; 12.8 | — |
| SECONDARY Clinical Benefit Rate |
55; 66; 57 | 0.33 |
| SECONDARY Duration of Clinical Benefit |
11.2; 11.5; 12.2 | — |
| SECONDARY Time to Treatment Failure |
3.8; 3.9; 3.4 | 0.95 |
| SECONDARY Overall Survival |
20.1; 20.2; 22.5 | 0.91 |
| SECONDARY Tolerability of Treatment |
221; 227; 230 | — |
Summary
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant, anastrozole, or exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. It is not yet known whether giving fulvestrant together with anastrozole is more effective than giving fulvestrant together with a placebo or exemestane alone in treating breast cancer.
PURPOSE: This randomized phase III trial is studying fulvestrant and anastrozole to see how well they work compared to fulvestrant and a placebo or exemestane alone in treating postmenopausal women with locally advanced or metastatic breast cancer.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the breast
- Locally advanced or metastatic disease
- Metastatic disease must be measurable or evaluable
- Patients with bone only metastases are eligible provided there is an evaluable site of bone metastasis that can be followed by x-ray, MRI, or CT scan
- Relapsed or progressed during prior treatment with single-agent nonsteroidal aromatase inhibitor (NSAI)*, meeting either of the following criteria:
- NSAI given as adjuvant therapy that lasted ≥ 12 months
- Achieved an objective complete response, partial response, or stable disease that lasted ≥ 6 months after prior first-line therapy with NSAI for locally advanced or metastatic disease
- Chemotherapy as part of the first-line therapy given before initiation of NSAI allowed NOTE: *Patients are required to continue to take NSAI until beginning of study treatment.
- No rapidly progressive visceral disease (i.e., lymphangitis carcinomatosa or diffuse hepatic involvement)
- Hormone receptor status:
- Estrogen receptor (ER) and/or progesterone receptor positive tumor
- No ER-unknown disease
PATIENT CHARACTERISTICS:
Sex
- Female
Menopausal status
- Postmenopausal, as defined by 1 of the following criteria:
- Age 60 and over
- Age 45 to 59 AND ≥ 12 months since last menstrual period with no prior hysterectomy
- Any age with prior bilateral oophorectomy
Performance status
- WHO 0-2
Life expectancy
- More than 3 months
Hematopoietic
- Neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- No thrombocytopenia
- Hemoglobin ≥ 10 g/dL
Hepatic
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 5 times ULN (unless due to bone metastases)
- No liver disease
Renal
- Creatinine 15 days within the past 4 weeks
Other
- More than 4 weeks since prior investigational drugs
- Concurrent bisphosphonates for bone metastases allowed provided bisphosphonate therapy has been established for ≥ 6 months
- Concurrent initiation of bisphosphonate allowed provided patient has soft tissue or visceral metastases as the measurable or evaluable target lesion
- No concurrent anticoagulant therapy
- No concurrent unlicensed noncancer investigational agents
Data sourced from ClinicalTrials.gov (NCT00253422). 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.