Study of Faslodex +/- Concomitant Arimidex v Exemestane Following Progression on Non-steroidal Aromatase Inhibitors

What this trial studies

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.

Conditions in scope

• Breast Cancer

Interventions

• Anastrozole (Drug) — This may be Anastrazole OR a placebo
• Exemestane (Drug)
• Fulvestrant (Drug)

Who can join

Women only · Ages 18 Years to 120 Years

Inclusion 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

Exclusion criteria

• See ClinicalTrials.gov for full exclusion criteria.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE3
• Start date: 2004-03-26
• Primary completion: 2022-11-28
• Last update posted: 2025-06-04
• First posted: 2005-11-15

Sponsor & contact

Lead sponsor: Institute of Cancer Research, United Kingdom (Other)

Collaborators: Royal Marsden NHS Foundation Trust

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Progression-free Survival (Assessed up to 190 months)
  defined as time from randomisation to progression of existing disease, new sites of disease, second primary cancer if change in systemic treatment was necessary, or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase…

Related ClearedRx care

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