Status:
COMPLETED
Study of Faslodex +/- Concomitant Arimidex v Exemestane Following Progression on Non-steroidal Aromatase Inhibitors
Lead Sponsor:
Institute of Cancer Research, United Kingdom
Collaborating Sponsors:
Royal Marsden NHS Foundation Trust
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-120 years
Phase:
PHASE3
Brief 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 cell...
Detailed Description
OBJECTIVES: Primary * Compare progression-free survival of postmenopausal women with estrogen receptor- and/or progesterone receptor-positive, locally advanced or metastatic breast cancer that relap...
Eligibility Criteria
Inclusion
- 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 \< 1.97 mg/dL
- Other
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- PRIOR CONCURRENT THERAPY:
- Chemotherapy
- See Disease Characteristics
- Prior neoadjuvant or adjuvant chemotherapy allowed
- Endocrine therapy
- See Disease Characteristics
- Prior tamoxifen as neoadjuvant or adjuvant therapy allowed
- No systemic corticosteroids that lasted \> 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
Exclusion
Key Trial Info
Start Date :
March 26 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2022
Estimated Enrollment :
698 Patients enrolled
Trial Details
Trial ID
NCT00253422
Start Date
March 26 2004
End Date
November 28 2022
Last Update
June 4 2025
Active Locations (2)
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1
Royal Marsden - London
London, England, United Kingdom, SW3 6JJ
2
Institute Of Cancer Research
Sutton, England, United Kingdom, SM2 5NG