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Browsing by Author "Kimmick, Gretchen"
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Item Patient-Reported Outcomes in the Translational Breast Cancer Research Consortium(Wiley, 2020-03) Bowen, Deborah J.; Shinn, Eileen H.; Gregrowski, Sophie; Kimmick, Gretchen; Dominici, Laura S.; Frank, Elizabeth S.; Smith, Karen Lisa; Rocque, Gabrielle; Ruddy, Kathryn J.; Pollastro, Teri; Melisko, Michelle; Ballinger, Tarah J.; Fayanju, Oluwadamilola M.; Wolff, Antonio C.; Medicine, School of MedicineMembers of the Translational Breast Cancer Research Consortium conducted an expert-driven literature review to identify a list of domains and to evaluate potential measures of these domains for inclusion in a list of preferred measures. Measures were included if they were easily available, free of charge, and had acceptable psychometrics based on published peer-reviewed analyses. A total of 22 domains and 52 measures were identified during the selection process. Taken together, these measures form a reliable and validated list of measurement tools that are easily available and used in multiple cancer trials to assess patient-reported outcomes in relevant patients.Item A phase II study of medroxyprogesterone acetate in patients with hormone receptor negative metastatic breast cancer: translational breast cancer research consortium trial 007(SpringerLink, 2014-11) Miller, Kathy D.; Althouse, Sandra K.; Nabell, Lisle; Rugo, Hope; Carey, Lisa; Kimmick, Gretchen; Jones, David R.; Merino, Maria J.; Steeg, Patricia S.; Medicine, School of MedicinePreclinical data suggest that medroxyprogesterone acetate (MPA) has both anti-metastatic and anti-angiogenic activity in the absence of hormone receptors (HR). This phase II trial assessed the activity of MPA alone or in combination with low-dose chemotherapy in patients with metastatic HR-negative breast cancer. Postmenopausal women with HR-negative disease were eligible if they had not received more than 3 chemotherapy regimens for metastatic disease. All patients were treated with MPA 1,000-1,500 mg/day orally; patients in cohort two also received low-dose oral cyclophosphamide and methotrexate (ldCM, 50 mg/day and 2.5 mg twice daily on Days 1 and 2 each week). Tissue and circulating biomarkers were assessed serially. The primary endpoint was clinical benefit response defined as objective response or stable disease >6 months. Thirty patients were enrolled (14 MPA monotherapy; 16 MPA + ldCM); median age was 55 (35-80); nearly all had visceral involvement. Despite dose escalation in 90 % of patients, only 17 (57 %) patients ever achieved MPA trough concentrations >50 ng/ml. One patient developed grade 4 renal failure in the setting of rapid disease progression and dehydration. There were no objective responses. One patient in each cohort (~7 %) had stable disease for > 6 months. Skin Nm23 expression increased after 4 weeks of MPA + ldCM, but there were no significant changes in TSP-1, PAI-1 antigen, or PAI-1 activity. MPA had limited activity and does not warrant further development in patients with HR-negative advanced breast cancer. Poor bioavailability limited exposure despite dose escalation.