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Sponsored by: |
Cancer Research UK |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00674557 |
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 not yet known whether giving exemestane together with ATN-224 is more effective than giving exemestane alone in treating patients with recurrent or advanced breast cancer.
PURPOSE: This randomized phase II trial is studying the side effects of exemestane given together with or without ATN-224 and to see how well it works in treating postmenopausal women with recurrent or advanced breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: SOD1 inhibitor ATN-224 Drug: exemestane Genetic: protein expression analysis Genetic: proteomic profiling Other: laboratory biomarker analysis Other: pharmacological study |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | A Cancer Research UK Randomised Phase II Trial of ATN-224 (Copper Binding Agent) in Combination With Exemestane Versus Exemestane Alone in Post-Menopausal Women With Recurrent or Advanced, Oestrogen and/or Progesterone Receptor Positive Breast Cancer |
Estimated Enrollment: | 111 |
Study Start Date: | June 2008 |
OBJECTIVES:
Primary
Secondary
Determine the response rate (overall, at 16 and 24 weeks), response duration, and rate of stable disease for
Tertiary
OUTLINE: This is a multicenter study. Patients are stratified according to prior aromatase inhibitor therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Blood samples are collected periodically for pharmacokinetic and pharmacodynamic assessments, including Cp levels, estradiol and estrone sulfate, SOD1 levels, cytokines, proteomics, circulating endothelial RNA, circulating endothelial cells, protein expression, and EGFR-related cell signaling pathways.
After completion of study treatment patients are followed at 28 days.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Measurable or evaluable disease by conventional techniques, with ≥ 1 lesion that can be followed for response
Hormone receptor status must meet 1 of the following criteria:
Estrogen receptor-positivity
Progesterone receptor-positivity
PATIENT CHARACTERISTICS:
Postmenopausal as defined by any of the following:
ATN-224 absorption, including any of the following:
Cystic fibrosis
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
PRIOR CONCURRENT THERAPY:
United Kingdom, England | |
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford | |
Oxford, England, United Kingdom, OX3 7LJ |
Principal Investigator: | Adrian L. Harris, MD | Churchill Hospital |
Study ID Numbers: | CDR0000595074, CRUK-CR0207-22, EUDRACT-2007-005752-16, EU-20850 |
Study First Received: | May 7, 2008 |
Last Updated: | March 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00674557 History of Changes |
Health Authority: | United States: Federal Government |
recurrent breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
stage IV breast cancer HER2-negative breast cancer estrogen receptor-positive breast cancer progesterone receptor-positive breast cancer |
Estrogens Progesterone Skin Diseases Breast Neoplasms Exemestane |
Copper Aromatase Inhibitors Menopause Breast Diseases Recurrence |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Therapeutic Uses |
Breast Neoplasms Enzyme Inhibitors Exemestane Aromatase Inhibitors Pharmacologic Actions Breast Diseases |