Evaluating the Feasibility of Performing Window of Opportunity Trials in Breast Cancer

• Published in: International Journal of Surgical Oncology Vol. 2015; no. 2015; pp. 74 - 82
• Main Authors: Clemons, Mark, Addison, Christina L., Pond, Gregory R., Simos, Demetrios, Kuchuk, Iryna, Robertson, Susan, Arnaout, Angel, Namazi, Mehrzad
• Format: Journal Article
• Language: English
• Published: Cairo, Egypt Hindawi Limiteds 01.01.2015; Hindawi Publishing Corporation; John Wiley & Sons, Inc; Hindawi Limited
• Subjects: Aged; Aged, 80 and over; Antineoplastic Agents, Hormonal - therapeutic use; Biomarkers, Tumor - metabolism; Biopsy; Breast cancer; Breast Neoplasms - drug therapy; Breast Neoplasms - metabolism; Breast Neoplasms - surgery; Cancer therapies; Carcinoma, Ductal, Breast - drug therapy; Carcinoma, Ductal, Breast - metabolism; Carcinoma, Ductal, Breast - surgery; Care and treatment; Chemotherapy; Chemotherapy, Adjuvant; Clinical Study; Clinical trials; Drug Administration Schedule; Feasibility Studies; Female; Hormone replacement therapy; Humans; Mastectomy; Metastasis; Methods; Middle Aged; Neoadjuvant Therapy; Nitriles - therapeutic use; Patient compliance; Pilot Projects; Prospective Studies; Studies; Surgeons; Surgery; Triazoles - therapeutic use
• ISSN: 2090-1402; 2090-1410
• DOI: 10.1155/2015/785793

Background. The waiting period to surgery represents a valuable “window of opportunity” to evaluate novel therapeutic strategies. Interventional studies performed during this period require significant multidisciplinary collaboration to overcome logistical hurdles. We undertook a one-year prospective window of opportunity study to assess feasibility. Methods. Eligible newly diagnosed postmenopausal, estrogen receptor positive breast cancer patients awaiting primary surgery received anastrozole daily until surgery. Feasibility was assessed by (a) the proportion of patients who consented and (b) completed the study. Comparison of pre- and poststudy Ki67 labelling index and cleaved caspase 3 scores (CC3) was performed. Results. 22/131 (16.8%) patients were confirmed eligible and 20/22 (91%) patients completed the study. 19/20 (95%) patients agreed to undergo optional additional tissue biopsies. The mean duration of anastrozole use was 24.7 (15–44) days. There were a statistically significant decline in mean Ki67 indices of 48.8% (p<0.001) and a trend towards significance in the decline of CC3 (p=0.17) when comparing pre- with posttreatment values. Conclusion. window of opportunity trials in breast cancer are a feasible way of assessing the biologic efficacy of different therapies in the presurgical setting. The majority of eligible women were willing to participate including undergoing additional tissue biopsies.