Status:
TERMINATED
Exemestane With or Without ATN-224 in Treating Postmenopausal Women With Recurrent or Advanced Breast Cancer
Lead Sponsor:
Cancer Research UK
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Exemestane may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. ATN-224 may stop the growth of breast cancer by blocking blood flow to the tumor. It is...
Detailed Description
OBJECTIVES: Primary * Compare progression-free survival of postmenopausal women with, estrogen receptor- and/or progesterone receptor-positive recurrent or advanced breast cancer treated with exemes...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer
- Recurrent disease after 2-3 years of adjuvant treatment with an anti-estrogen (documented by imaging techniques)
- Advanced disease that has recurred during or after anti-estrogen therapy
- Measurable or evaluable disease by conventional techniques, with ≥ 1 lesion that can be followed for response
- Bone metastases only are eligible provided they have ≥ 1 lytic lesion (not previously irradiated or planned for irradiation) that can be followed by X-ray or CT scanning
- Cutaneous skin metastases only are eligible provided the skin lesions are \> 10 mm and can be followed by good quality photography with a ruler included in the photograph
- No clinically apparent brain metastases
- Hormone receptor status must meet 1 of the following criteria:
- Estrogen receptor-positivity
- Score ≥ 3 on a scale (range of 0 to 8), or equivalent score from other grading methods, representing the intensity and percentage of positive-staining tumor cells by immunohistochemistry
- Greater than or equal to 5 fmol/mg protein by ligand binding assay or ELISA
- Progesterone receptor-positivity
- Score ≥ 3 on a scale (range of 0 to 8) or equivalent score from other grading methods, representing the intensity and percentage of positive-staining tumor cells by immunohistochemistry
- No HER-2 overexpression, defined as gene amplification by fluorescence in situ hybridization \[FISH\] OR 3+ overexpression by IHC)
- PATIENT CHARACTERISTICS:
- Postmenopausal as defined by any of the following:
- Surgical or radiation-induced
- No menstrual periods for 12 consecutive months with no other biological or physiological cause in women with an intact uterus
- Age ≥ 55 years
- WHO performance status 0-2
- Life expectancy ≥ 6 months
- Hemoglobin ≥ 9.0 g/dL
- ANC ≥ 1.5 x 10\^9/L
- Platelet count ≥100 x 10\^9/L
- Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT and/or AST ≤ 2.5 times ULN (5 times ULN if due to tumor)
- Creatinine clearance ≥ 50 mL/min
- No history of malabsorption syndromes or other gastrointestinal disorders that may affect SOD1 inhibitor ATN-224 absorption, including any of the following:
- Bowel obstruction
- Celiac disease
- Sprue
- Cystic fibrosis
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to SOD1 inhibitor ATN-224, omeprazole (or other proton pump inhibitor), or exemestane
- No non-malignant systemic disease including active uncontrolled infection
- No serologic positivity for hepatitis B, hepatitis C, or HIV
- No concurrent congestive heart failure
- No history of NYHA class III-IV cardiac disease
- No other concurrent malignancy, except adequately treated cone-biopsied carcinoma in situ of the uterine cervix, basal cell or squamous cell carcinoma of the skin
- Cancer survivors who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for 5 years, and are deemed at low risk for recurrence are eligible
- No other condition which, in the investigator's opinion, would not make the patient a good candidate for this study
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from all prior therapy (alopecia allowed)
- At least 1 year since prior bilateral oophorectomy
- Prior adjuvant or neoadjuvant treatment with tamoxifen allowed
- Prior adjuvant therapy with a non-steroidal aromatase inhibitor allowed
- More than 4 weeks since prior immunotherapy or chemotherapy (6 weeks for nitrosoureas and mitomycin-C)
- More than 4 weeks since prior major thoracic and/or abdominal surgery
- More than 3 weeks since prior endocrine therapy
- More than 4 weeks since prior and no concurrent radiotherapy (except to control pain or prevent fracture)
- No prior exemestane
- Concurrent iron-containing vitamins or supplements are allowed
- No concurrent luteinizing hormone-releasing hormone analog
- No concurrent oral bisphosphonates (IV bisphosphonates allowed)
- No concurrent chronic steroid therapy for concurrent illness or cancer (short-term steroid use for concurrent illness allowed \[e.g., for acute asthma\])
- No concurrent copper- or zinc-containing vitamins or supplements
- No concurrent participation in another interventional clinical study (participation in an observational study allowed)
- No other concurrent copper-binding drug (e.g., penicillamine or trientine)
- No other concurrent anticancer therapy or investigational agent
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT00674557
Start Date
June 1 2008
End Date
March 1 2009
Last Update
July 10 2013
Active Locations (1)
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1
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
Oxford, England, United Kingdom, OX3 7LJ