Introduction: We are conducting a phase II clinical trial of the GP2+GM-CSF vaccine for the prevention of breast cancer recurrence in disease-free, node-positive or high-risk node negative patients (pts). GP2 is an HLA-A2+-restricted immunogenic peptide from the HER2 protein (aa: 654-662) capable of stimulating CD8+ cytotoxic T-lymphocytes (CTLs) to recognize and destroy HER2-expressing tumor cells. Here, we present the final pre-specified analysis of our study, disease free survival (DFS) at one year from last enrolled pt. Methods: The trial is a prospective, randomized, multi-center, placebo-controlled, single-blinded, phase I/II trial designed to evaluate the safety and clinical efficacy of GP2 in breast cancer patients. Pts with any level of HER2 (immunohistochemistry [IHC] 1-3+) expression were enrolled after standard of care therapy. Blinded HLA-A2+ pts were randomized 1:1 to receive GP2 + GM-CSF or GM-CSF alone. Pts in both treatment arms received 6 monthly intradermal inoculations during the primary vaccine series (PVS) followed by 4 booster inoculations administered every 6 months. Data was collected for demographic, safety, immunologic, and clinical recurrence. Per the statistical plan, DFS was analyzed for both intention-to-treat population (ITT; all randomized pts) and per-treatment population (PT; excluding recurrences during the PVS and second malignancies) using Kaplan-Meir methods. Continuous variables are compared using analysis of variance techniques and proportions compared with Fisher's exact test. Results: This trial enrolled 180 pts (vaccine group n=89 and control group n=91). There were no differences in age, grade, hormone receptor status, tumor size or nodal status between groups (all p>0.2). With median follow up of 36.2 months, the five-year DFS estimates did not demonstrate a difference between vaccinated (VG) and control groups (CG) with ITT (82.6% v 80.4%, p=0.96, respectively) or PT (88.9% v 84.3%, p=0.52, respectively). On further subset analysis, in HER2 3+ by IHC (or positive via FISH) pts, ITT analysis showed a DFS of 93.8% v 87.2% (VG, n=50 v CG, n=51; p=0.67, respectively) while the PT analysis revealed a DFS of 100% v 87.2% (VG, n=48 v CG, n=50; p=0.052, respectively). In ER/PR+ pts, ITT analysis showed a DFS of 88.1% v 80.6% (VG, n=54 v CG, n=60; p=0.41, respectively) while PT analysis demonstrated a DFS of 91.5% v 85.2% (VG, n=52 v CG, n=57; p=0.42, respectively). Conclusions: The final pre-specified analysis of this randomized phase II trial of the GP2+GM-CSF adjuvant breast cancer vaccine shows no statistical differences between treatment arms. However, it does identify a particular patient population where the vaccine may have efficacy; HER2 3+ patients appear to derive the greatest clinical benefit from GP2 vaccination after trastuzumab treatment with the PT analysis nearing statistical significance. Further studies are required to confirm these findings and investigate the potential link between hormone receptor status and the induction of clinically beneficial anti-tumor immunity with this vaccine. Citation Format: Greene JM, Schneble EJ, Perez S, Murray JL, Berry JS, Trappey AF, Hale DF, Vreeland TJ, Clifton GT, Ardavanis A, Litton JK, Shumway NM, Papamichail M, Peoples GE, Mittendorf EA. Final pre-specified analysis of the phase II trial of the GP2+GM-CSF peptide vaccine in high risk breast cancer patients to prevent recurrence. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P2-11-01.

Male breast cancer, which represents only 1% of all breast cancers, is occasionally associated with a family history of breast cancer. Sporadic male breast cancers presenting with another primary breast cancer are extremely rare. In this article, we report on a 70-year-old male patient with bilateral multifocal and synchronous breast cancer and without a family history of breast cancer.

SUMMARY: Over the past two decades significant progress has been made in breast cancer treatment resulting in a substantial improvement in patients' outcome. But we have to think about who promotes all this research and the consequences of the type of fundingThis project aims to evaluate the implication of finance in clinical research and the variance according to the type of funding. OBJETIVES: To evaluate the financial evolvement of breast cancer clinical trials in the past two decades, regarding the phase of development design of the studies, the collaboration between Academy (Acad) and Industry (Ind), the sample size, the study results and the statistical analyses conducted. METHODS: A systematic review was performed using MEDLINE to identify breast cancer randomized clinical trials published between January1990 and December2010. Studies that involved chemotherapy, endocrine and/or targeted therapies, wherethe primary endpoint was considered adequate to support a drug approval in oncology according to the FDA and EMA (U.S. Food and Drug Administration and European Medicines Agency, respectively), were included. RESULTS:Data were evaluated 2,211 and 472 met selection criteria comprised in the methodology During the first decade the Acad was the main breast cancer research promoter being replaced by the Inv. throughout the second decade (p <0.0001). Thirty nine percent of the studies evaluated were phase III (39% Acad, 61% Ind), 15% were phase II (30% Acad, 70% Ind) and the remaining 47% were not classified by authors (65% Acad 35% Ind). As for the primary endpoint, 25% of the phase III trials evaluated progression free survival, 15% overall response rate, 1% time to progression and only 5% examined overall survival. Sixty five percent of the trials were national (60% Acad 40% Ind) and 35% international (25% Acad 75% Ind). Single-center studies accounted for 11% of the trial (65% Acad 35% Ind). Most of the national trials were developed by the US. Fifty four percent of the studies were conducted by research groups (67% supported by Ind. and 33% Acad.). The Ind sponsored 26% of the studies in the first decade and 50% during the second. The median number of patients enrolled by research groups was 892 in contrast with 409 included by other organizations. The primary endpoint was achieved in 19% of the Acad trials and 21% of the Ind trials. Only 53% of the studies declared intention to treat based analysis in their statistical workout. RESULTS  ACADEMY(%)INDUSTRY (%)PPROMOTION OF THE STUDY1990-2000121(26)68(14)0,0001 2001-2010105(22)178(38)0,0001STUDY DESIGNUNICENTRIC TRIALS34(7)18(4)0,007 MULTICENTRIC TRIALS191(40)228(48)  NATIONAL TRIALS183(39)122(26)0,0001 INTERNATIONAL TRIALS42(9)124(26)  COOPERATIVE GROUP95(20)160(34)  NOT COOPERATIVE GROUP130(28)86(18) STATISTICAL ANALYSISINTENT OF TREAT86(18)163(35)  NOT DECLARATED140(30)83(18)  CONCLUSIONS:There is a significant tendency towards the promotion of research by the pharmaceutical industries during the last two decades, leading a change in the clinical trials design and the endpoints. Citation Format: Jerez Y, Lopez-Tarruella S, Marquez-Rodas I, Perez S, Ocaña A, Echavarria I, Lobo M, Gallego I, Torres G, Ortega L, Garcia G, Palomero I, Gonzalez Del Val R, Massarrah T, Esteban M, Del Monte-Millan M, Martin M. Implications of financial modeling in breast cancer clinical research from 1990 to 2010 [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P4-20-01.