Dataset Information

Patterns in target-directed breast cancer research.

ABSTRACT: We undertake an analysis of ongoing BC targeted therapy trials registered to CT.gov to describe patterns of ongoing clinical research, highlight gaps in current research programs and identify ways of optimizing ongoing initiatives. A search of clinicaltrials.gov was conducted on September 4, 2013 to identify ongoing randomized phase II and III trials of targeted therapies in BC. A total of 280 trials were analyzed, the majority conducted in either human epidermal growth factor receptor 2 (HER2)-positive (n = 79, 28.2 %) or hormone receptor (HR)-positive (n = 104, 37.1 %) populations. Less than half of all trials were conducted in populations selected to match the agent under investigation (n = 126, 45 %). HER2-directed therapy is the single most investigated class of targeted agents (n = 73, 26.1 %), but trials investigating anti-angiogenic agents are also common (n = 49, 17.5 %). The most common new classes of agents under investigation in HR-positive and triple negative (TN)/BRCA-positive disease, are non-receptor protein kinase-inhibitors (n = 12; 11.5 %) and poly (ADP-ribose) polymerase inhibitors (n = 6; 30 %), respectively. The majority of regimens combine new targeted agents with either chemotherapy (n = 164, 58.6 %) or endocrine therapy (n = 113, 40.4 %); a total of 8 trials (2.8 %) investigated peptide-drug conjugates. The most frequently utilized end-points were pathological complete response in the neo-adjuvant setting (n = 36, 52.9 %) and time-to-event end-points in the adjuvant and advanced settings (77.3 and 72.6 %, respectively). Our findings suggest a need for more target-matched agent development, maintenance of a value-based focus in research and a need for the clinical development of agents to treat TN/BRCA-positive and HR-positive BC.

SUBMITTER: Torres S

PROVIDER: S-EPMC4735094 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Patterns in target-directed breast cancer research.

Torres Sofia S Simmons Christine C Boileau Jean-François JF McLeod Deanna D Martins Ilidio I Trudeau Maureen M

SpringerPlus 20160201

We undertake an analysis of ongoing BC targeted therapy trials registered to CT.gov to describe patterns of ongoing clinical research, highlight gaps in current research programs and identify ways of optimizing ongoing initiatives. A search of clinicaltrials.gov was conducted on September 4, 2013 to identify ongoing randomized phase II and III trials of targeted therapies in BC. A total of 280 trials were analyzed, the majority conducted in either human epidermal growth factor receptor 2 (HER2)- ...[more]

PMID: 26877907

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Project description:AbstractIt has been reported that some male breast cancer patients may refuse the recommended surgery, but the incidence rate in the United States is not clear. The purpose of this study was to identify the incidence, trends, risk factors, and eventual survival outcomes associated with the rejection of such cancer-directed surgery.We collected data on 5860 patients with male breast cancer (MBC) from the Surveillance, Epidemiology, and End Results database, including 50 patients refusing surgery as recommended. Kaplan-Meier survival analysis and Cox proportional hazard regression were used to identify the effects of refusing surgery on cancer-specific survival (CSS) and overall survival (OS). The association between acceptance or rejection of surgery and mortality were estimated by nested Cox proportional hazards regression models with adjustment for age, race, clinical characteristics, and radiation.Of the 5860 patients identified, 50 (0.9%) refused surgery. Old age (≥65: hazard ratio [HR]: 3.056, 95% confidence interval [CI]: 1.738-5.374, P < .0001), higher AJCC stage (III: HR: 3.283, 95% CI: 2.134-5.050, P < .0001, IV: HR: 14.237, 95% CI: 8.367-24.226, P < .0001), progesterone receptor status (negative: HR: 1.633, 95% CI: 1.007-2.648, P = .047) were considered risk factors. Compared with the surgery group, the refusal group was associated with a poorer prognosis in both OS and CSS (χ2 = 94.81, P < .001, χ2 = 140.4, P < .001). Moreover, significant differences were also observed in OS and CSS among 1:3 matched groups (P = .0002, P < .001).Compared with the patients undergoing surgery, the patients who refused the cancer-directed surgery had poor prognosis in the total survival period, particularly in stage II and III. The survival benefit for undergoing surgery remained even after adjustment, which indicates the importance of surgical treatment before an advanced stage for male breast cancer patients.

Project description:BackgroundAs breast cancer rates increase globally, there is growing scientific consensus that greater understanding of the causes of breast cancer is needed to better prevent its occurrence. Genetics accounts for a small percentage of cases, thus environmental factors and epigenetics are increasingly suspect in breast cancer etiology. Within the breast cancer and environmental breast cancer social movements, there are longstanding calls for research and policy aimed toward the prevention of breast cancer. To better understand the opportunities and barriers to addressing environmental contributors to breast cancer, this article investigates both outcomes and perceptions of stakeholders involved in the Interagency Breast Cancer and Environment Research Coordinating Committee (IBCERCC). The IBCERCC was mandated by the 2008 U.S. Breast Cancer and Environmental Research Act, a law representing years of advocate and researcher efforts to produce national strategies and federal funding for breast cancer prevention research.MethodsTo understand the meaning and impact of the IBCERCC advisory committee and final report, Prioritizing Prevention, I draw on fifteen confidential semi-structured interviews with members of the twenty-five person IBCERCC, in addition to six confidential semi-structured interviews with key breast cancer funders, advocates, and researchers affiliated with national reports on environmental contributors to cancer. I examine media coverage, congressional hearing transcripts, and official responses to the release of the IBCERCC report by governmental and non-governmental organizations.ResultsInterviews and publicly available documents reveal a set of direct and indirect outcomes of the 2013 IBCERCC report. Interviewees in government positions perceived the 2014 renewal of the Breast Cancer and the Environment Research Program to result from IBCERCC efforts, notable in the context of declining U.S. federal research funding. Interviews also revealed a suite of potential barriers to the implementation of report recommendations including: distinct interpretations of the federal mandate, disparate assessments of scientific evidence, government funding crises, and lack of specificity around responsibility for implementation of report findings.ConclusionThis article examines efforts to shift institutional research and funding priorities in cancer research towards prevention. Social science research can support efforts to shift institutional priorities by identifying broader social contexts and underlying values typically unnamed in scientific discourse.

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Patterns in target-directed breast cancer research.

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Patterns in target-directed breast cancer research.

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