tbuckley/cabot-search huggingface dataset:
A phase I study of NK012 in combination with 5-fluorouracil with or without leucovorin in patients (pts) with advanced solid tumors.
Authors: Suzanne Fields Jones, Howard A. Burris, Jeffrey R. Infante, Frank A. Greco, David R. Spigel, Shigeyuki Kawamura, Tatsunari Ishioka, Hiroko Yamazaki, Johanna C. Bendell
Journal: Journal of Clinical Oncology (2012)

e13076 Background: NK012 is a micelle-forming macromolecular prodrug of EHC (7-ethyl-10-hydroxycamptothecin), also known as SN-38, the active metabolite of irinotecan. Irinotecan-based regimens (including FOLFIRI) are commonly used in the treatment of gastrointestinal malignancies. The development of an improved irinotecan-based regimen either by improved efficacy, schedule, or toxicity profile, has the potential for a major role in the treatment of GI malignancies. Methods: Dose escalation study to determine the maximum tolerated dose and recommended phase II dose (RD) of NK012 (day 1) in combination with bolus 5FU/LV (400 /400 mg/m 2 ) followed by continuous infusion 5FU (2400mg/m 2 over 46 hrs) on days 1 and 15 every 28 days. Results: Twenty-three pts have been enrolled. NK012 was dosed at 16, 20, and 24 mg/m 2 in combination with 5FU/LV bolus + CI 5FU. Two of 3 pts at 24 mg/m 2 required a delay in the day 15 treatment due to myelosuppression. As a result, 20 mg/m 2 was determined to be the recommended NK012 dose in combination with 5FU/LV bolus + CI 5FU. The protocol was amended to eliminate the bolus 5FU/LV due to the potential for added myelosuppression, and NK012 was re-escalated with CI 5FU only. NK012 was dosed at 24 and 28 mg/m 2 . One DLT (nausea/vomiting requiring hospitalization) was reported among 6 pts treated at 28 mg/m 2 . The RD of NK012 in combination with CI 5FU is 28 mg/m 2 . Treatment-related toxicities included nausea (61%, 13% gr 3), fatigue (48%), neutropenia (44% gr 3-4), vomiting (35%, 4% gr 3), diarrhea (30%), anorexia (30%), stomatitis (26%), and alopecia (26%). Six pts (including 3 pancreatic) remained on study for &gt; 4 cycles, and two continued treatment for ≥ 1 year (colon, pancreatic). Conclusions: The combination of NK012 and CI 5FU is well tolerated, with NK012 administered at the recommended single-agent dose of 28 mg/m 2 . Further exploration of the regimen is warranted, particularly in patients with GI malignancies.
A randomized trial of 72-hour infusional bleomycin in BEP (cisplatin, etoposide, and bleomycin) versus conventional weekly bleomycin in patients with metastatic IGCCCG good prognosis disease.
Authors: Sarah Vinnicombe, Stephen John Harland, Johnathan K. Joffe, Robert Huddart, Danish Mazhar, Alison J. Birtle, Jeff D. White, Peter Wilson, Marita Marshall, Shah-Jalal Sarker, Jonathan Shamash
Journal: Journal of Clinical Oncology (2013)

4535 Background: Bleomycin is an integral part of combination chemotherapy in germ cell tumours. Pulmonary symptoms often dictate drug cessation and death occurs in 1-2% of patients. Circumstantial evidence suggests that continuous infusion may be less toxic. Methods: We conducted a randomized phase 3 study to see whether infusional bleomycin was associated with less pulmonary toxicity. Patients were stratified for smoking, renal dysfunction and age and were randomized to receive either conventional BEP with weekly bleomycin (3,0000 units /week iv over 30min) or the same doses but administered as a 90,000 unit infusion on day 1 over 72 hours. The primary endpoint was CT proven lung toxicity, secondary endpoints included PFS and changes in lung function testing. CT scans and lung function testing were conducted after 1 cycle, end of treatment and 1 year post treatment. Sample size of 210 was calculated to detect a difference of 16% Bleomycin damage with 80% power at the 5% level of significance using 2-sided test. Results: The median follow-up was 2.5 years. At day 21 of the treatment, 52% patients in the infusional arm had grade 1 or above toxicity compared to 55% in the conventional. At the end of treatment the results were 84% vs. 60% and at one year it was 65% vs. 59%. Repeated measures mixed effects model shows no significant difference in percentage of grade 1 and above toxicity between the two arms (Difference=1.63, P=0.09, 95% CI: -0.28, 3.54). However, there was a significantly higher level of grade 2 and above toxicity in patients in the infusion arm (difference=0.8; 95% CI 0.11 to 1.49). Toxicity level was the highest at the end of treatment and in older patients (Age&gt;30). Lung function testing between the two arms failed to show any differences. Two-years PFS rate was 93% in both arms (hazard ratio infusion vs conventional was 0.91; 95% CI 0.33 to 2.52). There was an association between toxicity after 1 cycle and subsequent toxicity at end of treatment and at 1 year (p=0.003). Conclusions: Infusional bleomycin has no advantage over standard administration of bleomycin. Clinical trial information: 08648791.
There is more to the picture than meets the eye: Population-based study on biopsy verification of suspected breast cancer recurrences.
Authors: Ulla Wilking, Thomas Hatschek, Jonas C. S. Bergh, Linda Sofie Lindström
Journal: Journal of Clinical Oncology (2015)

542 Background: Core biopsy/Fine needle aspiration (Bx) is recommended to confirm the diagnosis of Recurrent Breast Cancer (RBC). Up to 10% of all Bx are not RBC but benign or other malignancy. Hormone Receptor (HR)/HER2 status is known to change impacting management of RBC. The objective was to study the proportion of benign/other malignancies in suspected RBC, as well as to study the change in subgroup (see Methods) between PBC/RBC and consecutive RBCs from the same patient. Methods: In a population-based cohort in Stockholm, Sweden, of women with a diagnosis of RBC during 2007 until 2012 (and PBC before 2007), we reviewed all Bx-reports after PBC diagnosis. Exclusion criteria: stage IV disease, bilateral breast cancer. The trigroup was defined as three subgroups, HR+/HER2-, HER2+ and triple negative (TNBC), and compared between PBC/RBC and multiple RBCs from the same patient. Results: Only 60 patients did not undergo Bx and there were a total of 1034 Bx samples in 453 women with RBC. Sites of sample: bone, ascites, lung/pleura, CNS, liver, spleen, GI, gyn, etc. Results of Bx show that suspected RBC may be other malignancy (3%), benign (35%) or inconclusive (6%). Of the 52 lung/pleura samples were 2 lung cancers, 10 were cancers of unknown primary (CUP) and 6 showed inflammation. Of the 56 liver biopsies one was hemangioma and one showed inflammation. Also, one of the 185 local biopsies showed to be a neuroendocrine tumor. Tumor trigroup changed between PBC and RBC in almost one out of three patients as well as between consecutive RBCs (see table). Conclusions: For correct clinical management of patients with RBC it is essential to take Bx of any suspected site, since up to 55% of suspected RBC lesions are not RBC. Furthermore, biology changed in around 30% of patients, also between consecutive relapses. PBC RBC Total HR+ and HER2- Number (%) HER2+ Number (%) TNBC Number (%) HR+ and HER2- 38 (36.2) 7 (6.7) 8 (7.6) HER2+ 3 (2.9) 13 (12.4) 2 (1.9) TNBC 7 (6.7) 3 (2.9) 24 (22.9) Total number 48 (45.7) 23 (21.9) 34 (32.4) 105 FIRST RBC CONSECUTIVE RBC HR+ and HER2- 23 (50) 3 (6.5) 2 (4.3) HER2+ 1 (2.2) 5 (10.9) 0 TNBC 3 (6.5) 3 (6.5) 6 (13) Total number 27 (58.7) 11 (23.9) 8 (17.4) 46
Nanoscale analysis of changes in signaling proteins in patients treated with single agent atorvastatin for low-grade or refractory NHL
Authors: A. C. Fan, M. W. Orban, A. E. Shirer, R. Rajwanshi, C. Kong, Y. Natkunam, H. E. Lee, S. Coutre, D. W. Felsher
Journal: Journal of Clinical Oncology (2009)

11011 Background: In preclinical studies using our transgenic lymphoma model, lymphoma regression upon atorvastatin treatment was associated with increased apoptosis and changes in phosphorylation of key signaling pathways including MAPK and STAT. To determine if statins affect tumor signaling in patients, we designed a single arm phase II study, “Atorvastatin in Patients with Low Grade or Refractory Non-Hodgkin's Lymphoma.” Methods: Patients received 80 mg atorvastatin daily and underwent tumor sampling and PBMC collection by fine needle aspiration (FNA) and blood draw on days 1 and 8. The primary endpoint was to measure a 50% increase in tumor apoptosis on treatment day 8 compared with day 1. To characterize changes in protein profiles, we have developed the use of a novel nano-immunoassay system (NIA) to simultaneously measure both phosphorylated and unphosphorylated protein isoforms. NIA and multi-color flow cytometry were used to evaluate intracellular signaling protein profiles for each patient's tumor cells, monocytes, and T cells. Results: All 14 patients have completed treatment. The primary endpoint was reached in 9 of 14 patients with 50% increase in apoptosis. We distinguished three patterns of signaling changes. First, as expected, pathways that were initially activated in tumor cells decreased upon treatment with atorvastatin, with up to a 70% decrease in phospho-STAT3 and phospho-STAT5. Second, pathways that were initially suppressed in tumor cells (including phospho-PLCγ), normalized upon treatment. Third, expression levels of proteins in apoptotic pathways, including p38, increased upon atorvastatin treatment. Finally, changes in signaling associated with atorvastatin are cell specific: effects on tumor cells were distinct from effects on non-tumor T cells and monocytes. Conclusions: Single agent atorvastatin has a measurable effect on tumor bioactivity in patients with lymphoma. NIA and multi-color phosphoFACS can be used to monitor changes in cell signaling in very small clinical samples during therapeutic interventions. Determining whether specific signaling molecules may be a biomarker for identifying lymphoma patients that respond to atorvastatin is worthy of further investigation. [Table: see text]
Outcomes of hematopoietic stem cell transplant (HSCT) in HIV patients in HAART era.
Authors: Kathan Mehta, Annie P. Im, Hong Wang, Peter Veldkamp
Journal: Journal of Clinical Oncology (2015)

7030 Background: Prior studies have shown that outcomes of HSCT in HIV patients are similar to non-HIV patients since effective implementation of HAART by 1998; but they are limited by small sample size or non-inclusion of recent data. Methods: We queried National Inpatient Sample, a largest inpatient dataset in US, from 1998 to 2012 for HSCT using ICD9 procedure code 41.0. HIV patients were identified by ICD9 diagnostic code of 042, 043, 044, V08 and 079.53. Primary outcome was in-hospital mortality and secondary outcomes were in-hospital complications of HSCT. Results: 39,517 Patients who underwent HSCT were identified (weighted N = 192,562). Among these 108 patients had HIV (weighted N = 520). There was no difference in in-hospital mortality, intubation, sepsis, bacteremia, or graft vs host disease (GVHD) between HIV and non-HIV patients after HSCT. In allogeneic HSCT, HIV patients had significantly higher incidence of non-tuberculous mycobacteria (NTM), cytomegalovirus (CMV) and fungal infections as compared to non-HIV patients. Incidence of stomatitis was lower in HIV patients after allogeneic HSCT. In autologous HSCT, herpes simplex virus (HSV) infection was more common in HIV patients (Table). Conclusions: While HIV patients are not at higher risk of serious in-hospital complications of HSCT, they are at higher risk of opportunistic infections (OI’s). Further research is needed to prevent OI’s in HIV patients after HSCT. Outcomes of HSCT in USA. Outcome (%) Autologous HSCT (weighted N = 112,365) Allogeneic HSCT (weighted N = 80,198) HIV (+) patients (weighted N = 439) HIV (-) patients (weighted N = 111,925) P value* HIV (+) patients (weighted N = 81) HIV (-) patients (weighted N = 80,117) P value* In-hospital mortality 2.2 2.2 1.0 11.5 10.2 0.8 Intubation 3.1 2.5 0.7 6.1 8.2 0.8 Sepsis 6.3 8.1 0.5 28.8 13.1 0.1 Bacteremia 10.7 16.0 0.2 40.2 23.3 0.2 OI’s NTM 0.0 0.1 n/a 5.4 0.2 <0.0001 CMV 0.0 0.7 n/a 22.0 6.3 0.04 HSV 10.7 2.0 <0.0001 0.0 3.2 n/a Fungal infection 6.0 6.7 0.8 29.0 12.3 0.02 Other infections 29.1 20.5 0.06 39.9 29.9 0.5 GVHD (available from 2008) 0.0 0.7 n/a 22.9 17.9 0.6 Stomatitis 41.3 46.4 0.5 24.2 46.0 0.01 Total parenteral nutrition 9.0 13.1 0.3 11.8 23.4 0.1 * Rao-scott chi square test.
The Role of Chip-Related DNA Damage Response Dysfunction in Therapy-Related Myeloid Neoplasms
Authors: Ana Alfonso Pierola, Matteo Marchesini, Koichi Takahashi, Irene Gañán-Gómez, Elena Fiorini, Yamini Ogoti, Esperanza Irles, Guillermo Montalban-Bravo, Silver Sofia, Karen C. Dwyer, Guillermo Garcia-Manero, Simona Colla
Journal: Blood (2016)
PROGNOSTIC VALUE AND DETERMINANTS OF LEFT ATRIAL FUNCTION ASSESSED BY CARDIAC MAGNETIC RESONANCE IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION
Authors: Jakob Ledwoch, Thomas Stiermeier, Georg Fuernau, Suzanne de Waha, Charlotte Eitel, Janine Poess, Steffen Desch, Gerhard Schuler, Holger Thiele, Ingo Eitel
Journal: Journal of the American College of Cardiology (2017)
Impact of hormone receptor (HR) status on clinicopathological features, patterns of recurrence, and clinical outcomes among patients (pts) with human epidermal growth factor receptor-2 positive (HER2) breast cancer (BC) in the National Comprehensive Cancer Network (NCCN).
Authors: Ines Maria Vaz Duarte Luis, Rebecca A Ottesen, Melissa E Hughes, P. Kelly Marcom, Beverly Moy, Hope S. Rugo, Richard L. Theriault, John Wilson, Joyce C. Niland, Jane C. Weeks, Nancy U. Lin
Journal: Journal of Clinical Oncology (2012)

599 Background: According to gene expression profiling, HER2+ BC is heterogeneous and appears to diverge by HR status. Methods: We evaluated 3394 pts who presented to NCCN centers with stage I-III HER2+ BC between 2000-07. Pts were classified as HR+ (ER+ and/or PR+) and HR- (ER- and PR-). Chi-square, univariate logistic regression, log-rank test, and Cox hazard proportional regression were used for analysis. Results: Median follow-up was 51 months. 59% of patients had HR+ and 41% HR- disease respectively. Pts with HR- BC were more likely to be postmenopausal and to present with higher stage and high grade disease (p&lt;0.001). Most pts received adjuvant or neoadjuvant therapy; 44% received adjuvant trastuzumab. Recurrences were recorded for 458 pts. HR- patients were more likely to recur first in the central nervous system (CNS) (OR: 1.8, 95% CI: 1.1, 2.9; p= 0.03) and less likely to recur in bone (OR: 0.5, 95% CI: 0.3, 0.8; p&lt;0.01). No differences in risk of lung or liver recurrence were observed. Combining first and subsequent sites of recurrence, the difference in CNS involvement was lost (p=0.107) but HR- were more likely to experience lung involvement (OR: 1.5, 95% CI: 1.0, 2.2; p= 0.05). After adjusting for age, year of diagnosis (y), race, stage, and grade, HR- had worse survival after initial BC diagnosis than HR+ pts (Hazard Ratio of death [HRd] 1.4, 95% CI: 1.14, 1.7; p&lt;0.01). However, the risk of death was not proportional over time with HR- having significantly increased hazard in the first five years: HRd 0-2 y 1.9 [1.3, 2.9]; p&lt; 0.01; HRd 2-5y 1.5, [1.2, 2.0]; p&lt;0.01; HRd 5+ y, 0.8, [ 0.6, 1.2], p=0.29. Conclusions: Clinicopathological features, sites of recurrence, and risk of death over time for HER2+ BC differed by HR status. This suggests that HR status in HER2+ BC is clinically relevant. These differences should be further explored from a mechanistic and therapeutic standpoint.
Prognostic Discrimination of Children and Adolescents with Chronic Myeloid Leukemia Based on the EUTOS Long Term Survival (ELTS) Score
Authors: Frédéric Millot, Joelle Guilhot, Meinolf Suttorp, Adalet Meral Güneş, Petr Sedlacek, Evelina S De Bont, Chi Kong Li, Krzysztof Kalwak, Birgitte Lausen, Srdjana Culic, Barbara De Moerloose, Andrea Biondi, Andre Baruchel
Journal: Blood (2016)
LIPID ABNORMALITIES IN YOUNG PATIENTS WITH MYOCARDIAL INFARCTION
Authors: Bradley Collins, Avinainder Singh, Arman Qamar, Sanjay Divakaran, Josh Klein, Jon Hainer, Petr Jarolim, Ravi Shah, Jorge Plutzky, Donna Polk, Marcelo Di Carli, Khurram Nasir, Deepak Bhatt, Ron Blankstein
Journal: Journal of the American College of Cardiology (2017)
Association of disregulated neuronal and peripheral BDNF with vulnerability to paclitaxel-induced peripheral neuropathy.
Authors: David Azoulay, Anca Leibovici, Rivka Sharoni, Eti Shaoul, Bella Gross, Celia Suriu, Luiza Akria, Andrei Braester, Hadassah Goldberg
Journal: Journal of Clinical Oncology (2015)

1023 Background: Brain Derived Neurotrophic Factor (BDNF) is important for neuronal survival and repair. We hypothesized that a disregulated neuronal and peripheral BDNF may enhance vulnerability to Paclitaxel-Induced Peripheral Neuropathy (PIPN). Methods: 21 women with breast cancer were examined for peripheral neuropathy at baseline and during paclitaxel treatment, using the Total Neuropathy Score (TNSr) and the neurotoxicity subscale; Fact/GOG-NTx. Allelic discrimination of val66met BDNF polymorphism, which is reported to cause a deficit in the cellular distribution and regulated secretion of neuronal BDNF, was done by PCR and DNA sequencing. Peripheral BDNF was studied by analyzing the delta between the BDNF protein levels at baseline and after 8 weeks of treatment in each patient as was measured by ELISA. Results: Seven of the patients (33.3%) had TNSr ≥ 2 at baseline and identified to have pre-existing peripheral neuropathy (PEX-PN). The remaining 14 patients (66.7%) were identified as non-pre-existing peripheral neuropathy (NPEX-PN). The frequency of BDNF-SNP in the study population was Val/Val in 13 patients (62%) and Val/Met in 8 patients (38%). None of the patients were Met/Met (0%). We found a significantly higher incidence of the Val/Met genotype in the PEX-PN group than in NPEX-PN (5 out of 7 (71.4%) vs. 3 out of 14 (21.4%) respectively). Correspondingly, patients carrying the Val/Met genotype reached higher maximal TNSr and Fact-GOG scores in response to paclitaxel compared to Val/Val patients (4.69±0.74 vs. 8.87±2, respectively, prob > t 0.02; and 8.69±1.96 vs. 20.37±3.24, respectively, prob > t 0.002). As regards peripheral BDNF we found that BDNF decreased in patients with PEX-PN along their treatment with paclitaxel while it increased in NPEX-PN (–1.58 ± 2.80 ng/ml vs. +6.16±2.58 ng/ml, respectively, prob > t = 0.03). Conclusions: BDNF may play a protective role in PIPN, and exhaustion of its peripheral resources may lead to the exacerbation of PIPN. The genetic data presented here suggests that dysfunctional neuronal BDNF-induced repair mechanism due to BDNF-SNP may be a predisposing condition that exacerbates PIPN.
Surgical decision making in breast cancer: The patients' perspective.
Authors: Ilicia Lauren Shugarman, Lynne Meyer, Avan Armaghani, Karen Colleen Daily
Journal: Journal of Clinical Oncology (2015)

e20576 Background: Following demonstration of equivalent survival for patients treated with breast conservation surgery (BCS) followed by radiation compared to mastectomy, rates of BCS increased. In recent years without new data to suggest inferior outcomes, rates of mastectomy have increased. We sought to understand the decision-making process to gain insight into this trend. Although patients ultimately make their own surgical decisions, rates of BCS are often a measure of excellence by accrediting organizations. We suspected two factors could be contributing: (1) inaccurate risk perceptions, fear and anxiety in the stressful setting of a new cancer diagnosis, and (2) input from survivors who have opted for mastectomy. We also suspected there would be a higher rate of dissatisfaction among BCS than mastectomy patients for these same reasons. Methods: A paper survey was distributed to all patients with a breast cancer diagnosis scheduled for an appointment in the UF Health Oncology Clinic between 10/14-12/14. Results: Out of 90 patients, 47 had BCS and 43 had mastectomy. An additional 3 patients underwent both a mastectomy and BCS as they had 2 separate breast cancer diagnoses. Overall, more patients were happy with their surgical choice than expected (83.5%, n = 76). Only 2.2% (n = 2) of patients wished they had chosen a mastectomy instead of BCS, which excluded those who did not have choice of surgery type (13.2%, n = 12). When asked about factors influencing their decision, BCS patients rated the following significantly more important: did not want radiation (p = .041), appearance (p = .046), and recovery time. (p = .011). Mastectomy patients rated fear of cancer returning (p = .038) significantly more important. Conclusions: It is encouraging that the majority of survivors were satisfied with their surgical decision. Our survey identified two areas in which patient education could be improved. The first was expected and is that women whose decision is most influenced by fear of recurrence select mastectomy. The second area was not anticipated; patients undergoing BCS were not well informed about the need for breast radiation. Physicians who counsel women on surgical options could use this information to improve the shared decision making process.
PREDICTION OF ACUTE KIDNEY INJURY IN PATIENTS UNDERGOING CORONARY INTERVENTION USING CALCULATION OF SERUM OSMOLALITY
Authors: Serdar Farhan, Madhav Sharma, Shrema Parikh, Birgit Vogel, Usman Baber, Samantha Sartori, Michela Faggioni, Jaya Chandrasekhar, Sabato Sorrentino, Choudhury Hasan, Nitin Barman, Pooja Vijay, Srushti Shah, Jason Kovacic, Pedro Moreno, Gennaro Giustino, George Dangas, Roxana Mehran, Annapoorna Kini, Samin Sharma
Journal: Journal of the American College of Cardiology (2017)
Targeting the androgen receptor (AR) in women with AR+ ER-/PR- metastatic breast cancer (MBC).
Authors: Ayca Gucalp, Sara M. Tolaney, Steven J. Isakoff, James N. Ingle, Minetta C. Liu, Lisa A. Carey, Kimberly L. Blackwell, Hope S. Rugo, Lisle Nabell, Andres Forero-Torres, Vered Stearns, Lamia Momen, Joseph Gonzalez, Dilip D. Giri, Sujata Patil, Kimberly Feigin, Clifford Hudis, Tiffany A. Traina
Journal: Journal of Clinical Oncology (2012)

1006 Background: Patients (pts) with ER-/PR- MBC do not benefit from endocrine treatment (tx). Doane et al (Oncogene 2006;25:3994) described a subset of ER-/PR- BC with a gene expression profile similar to ER+ BC but characterized by AR expression and AR-dependent growth in vitro. Hence, we conducted a multicenter phase II trial (NCT00468715) of the AR antagonist, bicalutamide (B) for pts with AR+ ER-/PR- MBC. Methods: Pts with ER-/PR- (IHC &lt;10%) MBC were consented to AR testing, confirmed centrally at MSKCC. If AR+ (DAKO IHC ≥10%), pts were eligible for tx if ECOG performance status (PS) &lt;2 and normal organ function. No limit on prior tx except prior trastuzumab required if HER2+. Eligible AR+ pts who consented to tx received B 150mg orally daily in 28-day cycles (C). Toxicity assessed q4wks, response q12wks. Primary endpoint = clinical benefit rate (CBR): CR + PR + stable disease (ds) &gt;6mo (SD). B would be considered worthy of further study if ≥4/28 pts have clinical benefit. Results: As of 12/21/11,436 pts consented for AR testing. 24 were ineligible, 12 await testing. 47/400 tested were AR+ (12%). 26 received tx with B (6 ineligible for tx, 15 are eligible for tx with B at progression (POD) if clinically appropriate and study slots remains). Two AR+ pts treated with B were ER+ and removed from study. Three have received tx &lt;12wks. Treated pt characteristics (n=24): median(med)age 64 (41-83), PS 0 (0-1), HER2+ 1, visceral metastases 17. Prior chemotherapy: neo/adjuvant 16; med # regimens for MBC 1 (0-8). Med C# 3 (2-49+). Best response: (21 evaluable pts): CBR 19% (95% CI 5-42%), SD&gt;6mo 4, CR/PR 0, SD&lt;6mo 3, POD 14. Conclusions: ~12% of ER-/PR- MBC pts are AR+. For these pts, AR-inhibition with B is feasible, well tolerated, and has activity based on pre-specified criteria. This study has closed to accrual for AR testing as of 1/2012. These results of the primary endpoint are not expected to change by accrual of the 2 remaining pts. Supported by TBCRC/Breast Cancer Alliance/AstraZeneca. [Table: see text]