Pub Date : 2021-02-15DOI: 10.1158/1538-7445.sabcs20-ot-21-01
I. Acerbi, A. Fiscalini, Mandy Che, Yiwey Shieh, L. Madlensky, J. Tice, E. Ziv, M. Eklund, Amie M. Blanco, B. Tong, D. Goodman, L. Nassereddine, N. Anderson, H. Harvey, Steele Fors, H. Park, Antonia Petruse, S. Stewart, J. Wernisch, L. Risty, Ian Hurley, B. Koenig, Celia Kaplan, Robert Hiatt, Neil S. Wenger, Vivian Lee, D. Heditsian, S. Brain, L. Sabacan, Tianyi Wang, B. Parker, A. Borowsky, H. Anton-Culver, A. Naeim, A. Kaster, M. Talley, L. J. van ’t Veer, A. LaCroix, O. Olopade, Deepa Sheth, Augustin Garcia, R. Lancaster, L. Esserman
{"title":"Abstract OT-21-01: Personalized breast cancer screening in a population-based study: Women informed to screen depending on measures of risk (WISDOM)","authors":"I. Acerbi, A. Fiscalini, Mandy Che, Yiwey Shieh, L. Madlensky, J. Tice, E. Ziv, M. Eklund, Amie M. Blanco, B. Tong, D. Goodman, L. Nassereddine, N. Anderson, H. Harvey, Steele Fors, H. Park, Antonia Petruse, S. Stewart, J. Wernisch, L. Risty, Ian Hurley, B. Koenig, Celia Kaplan, Robert Hiatt, Neil S. Wenger, Vivian Lee, D. Heditsian, S. Brain, L. Sabacan, Tianyi Wang, B. Parker, A. Borowsky, H. Anton-Culver, A. Naeim, A. Kaster, M. Talley, L. J. van ’t Veer, A. LaCroix, O. Olopade, Deepa Sheth, Augustin Garcia, R. Lancaster, L. Esserman","doi":"10.1158/1538-7445.sabcs20-ot-21-01","DOIUrl":"https://doi.org/10.1158/1538-7445.sabcs20-ot-21-01","url":null,"abstract":"","PeriodicalId":342683,"journal":{"name":"Ongoing Clinical Trials Abstracts","volume":"70 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116607031","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-02-15DOI: 10.1158/1538-7445.SABCS20-OT-33-01
E. Mittendorf, S. Tolaney, P. Wileyto, M. Demeo, H. Rugo, R. Nanda, I. Mayer, B. Park, Heather MacArthur, Angela DeMichelle
Background: TNBC patients with residual disease after neoadjuvant chemotherapy (NAC) have high recurrence rates. Targetable mechanisms likely responsible for NAC resistance must therefore be identified to identify new therapeutic options. Alterations in the PI3K/mTOR pathway as well as expression of the immune checkpoint PD-L1 have emerged as potential targets, with significant frequency of alteration in TNBC. Importantly, the AKT inhibitor ipatasertib (ipat) and the anti-PD-L1 antibody atezolizumab (atezo) have demonstrated activity against TNBC. Recent data suggests that the presence of circulating tumor cell-free DNA (cfDNA) following NAC correlates with residual disease and a higher recurrence risk. We have hypothesized that combination therapy with ipat and atezo will target micrometastatic disease, as determined by the presence of cfDNA after NAC, in TNBC patients. Trial design:Open label single-arm phase II study to evaluate combination therapy with ipat and atezo, in TNBC patients with detectable cfDNA after completion of NAC, definitive surgery, and adjuvant radiation and/or chemotherapy. Eligible patients will receive: atezo [840mg IV days 1 and 15 and ipat [400 mg orally daily on days 1-21, followed by one week off] in a 28-day cycle for 6 cycles; cfDNA will be evaluated after 3 and 6 cycles. Biomarkers including PD-L1 expression on tumor cells or infiltrating immune cells in the primary tumor or PD-L1 expression on circulating tumor cells will be assessed. Eligibility criteria:Patients ≥ 18 yrs of age with pathologically confirmed residual invasive TNBC (ER and PR negative defined as Citation Format: Elizabeth Mittendorf, Sara Tolaney, Paul Wileyto, Michelle DeMeo, Hope Rugo, Rita Nanda, Ingrid Mayer, Ben Park, Heather MacArthur, Angela DeMichelle. Combination ipatasertib and atezolizumab to prevent recurrence in triple negative breast cancer(TNBC): A phase II single arm trial [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr OT-33-01.
背景:新辅助化疗(NAC)后残留病变的TNBC患者复发率高。因此，必须确定可能导致NAC耐药的靶向机制，以确定新的治疗方案。PI3K/mTOR通路的改变以及免疫检查点PD-L1的表达已成为潜在的靶点，在TNBC中具有显著的改变频率。重要的是，AKT抑制剂ipatasertib (ipat)和抗pd - l1抗体atezolizumab (atezo)已被证明具有抗TNBC的活性。最近的数据表明，NAC后循环肿瘤无细胞DNA (cfDNA)的存在与残留疾病和更高的复发风险相关。我们假设ipat和atezo联合治疗将针对TNBC患者的微转移性疾病，这是由NAC后cfDNA的存在决定的。试验设计:开放标签单臂II期研究，评估在完成NAC、最终手术和辅助放疗和/或化疗后cfDNA可检测的TNBC患者中，ipat和atezo联合治疗。符合条件的患者将接受:atezo[第1天和第15天静脉注射840mg, ipat[第1-21天每天口服400 mg，随后休息一周]，28天周期为6个周期;cfDNA将在3和6个周期后进行评估。生物标志物包括肿瘤细胞或原发肿瘤浸润性免疫细胞上的PD-L1表达或循环肿瘤细胞上的PD-L1表达将被评估。入选标准:年龄≥18岁，病理证实浸润性残余TNBC (ER和PR阴性，定义为引用格式:Elizabeth Mittendorf, Sara Tolaney, Paul Wileyto, Michelle DeMeo, Hope Rugo, Rita Nanda, Ingrid Mayer, Ben Park, Heather MacArthur, Angela DeMichelle。ipatasertib联合atezolizumab预防三阴性乳腺癌(TNBC)复发:一项II期单臂试验[摘要]。参见:2020年圣安东尼奥乳腺癌虚拟研讨会论文集;2020年12月8-11日;费城(PA): AACR;癌症杂志，2021;81(4增刊):摘要nr OT-33-01。
{"title":"Abstract OT-33-01: Combination ipatasertib and atezolizumab to prevent recurrence in triple negative breast cancer(TNBC): A phase II single arm trial","authors":"E. Mittendorf, S. Tolaney, P. Wileyto, M. Demeo, H. Rugo, R. Nanda, I. Mayer, B. Park, Heather MacArthur, Angela DeMichelle","doi":"10.1158/1538-7445.SABCS20-OT-33-01","DOIUrl":"https://doi.org/10.1158/1538-7445.SABCS20-OT-33-01","url":null,"abstract":"Background: TNBC patients with residual disease after neoadjuvant chemotherapy (NAC) have high recurrence rates. Targetable mechanisms likely responsible for NAC resistance must therefore be identified to identify new therapeutic options. Alterations in the PI3K/mTOR pathway as well as expression of the immune checkpoint PD-L1 have emerged as potential targets, with significant frequency of alteration in TNBC. Importantly, the AKT inhibitor ipatasertib (ipat) and the anti-PD-L1 antibody atezolizumab (atezo) have demonstrated activity against TNBC. Recent data suggests that the presence of circulating tumor cell-free DNA (cfDNA) following NAC correlates with residual disease and a higher recurrence risk. We have hypothesized that combination therapy with ipat and atezo will target micrometastatic disease, as determined by the presence of cfDNA after NAC, in TNBC patients. Trial design:Open label single-arm phase II study to evaluate combination therapy with ipat and atezo, in TNBC patients with detectable cfDNA after completion of NAC, definitive surgery, and adjuvant radiation and/or chemotherapy. Eligible patients will receive: atezo [840mg IV days 1 and 15 and ipat [400 mg orally daily on days 1-21, followed by one week off] in a 28-day cycle for 6 cycles; cfDNA will be evaluated after 3 and 6 cycles. Biomarkers including PD-L1 expression on tumor cells or infiltrating immune cells in the primary tumor or PD-L1 expression on circulating tumor cells will be assessed. Eligibility criteria:Patients ≥ 18 yrs of age with pathologically confirmed residual invasive TNBC (ER and PR negative defined as Citation Format: Elizabeth Mittendorf, Sara Tolaney, Paul Wileyto, Michelle DeMeo, Hope Rugo, Rita Nanda, Ingrid Mayer, Ben Park, Heather MacArthur, Angela DeMichelle. Combination ipatasertib and atezolizumab to prevent recurrence in triple negative breast cancer(TNBC): A phase II single arm trial [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr OT-33-01.","PeriodicalId":342683,"journal":{"name":"Ongoing Clinical Trials Abstracts","volume":"184 2 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116959381","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-02-15DOI: 10.1158/1538-7445.sabcs20-ot-28-06
N. Grover, D. Barton, A. Ronczka, J. Bauml
{"title":"Abstract OT-28-06: A phase 1, first in human study of adenovirally transduced autologous macrophages engineered to contain an anti-HER2 chimeric antigen receptor in subjects with HER2 overexpressing solid tumors","authors":"N. Grover, D. Barton, A. Ronczka, J. Bauml","doi":"10.1158/1538-7445.sabcs20-ot-28-06","DOIUrl":"https://doi.org/10.1158/1538-7445.sabcs20-ot-28-06","url":null,"abstract":"","PeriodicalId":342683,"journal":{"name":"Ongoing Clinical Trials Abstracts","volume":"19 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115138990","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-02-15DOI: 10.1158/1538-7445.sabcs20-ot-18-01
N. Wagle, C. Painter, E. Anastasio, Michael Dunphy, Mary McGillicuddy, Esha Jain, Brett N. Tomson, Tania G. Hernandez, Beena S. Thomas, Dewey Kim, Alyssa L. Damon, Shahrayz Shah, Rafael Ramos, Colleen M. Nguyen, Lee O'Neil, S. Winnicki, Sara Balch, Rachel E. Stoddard, T. Cusher, P. Chastain, J. G. T. Zañudo, Jorge E. Buendia-Buendia, Ofir Cohen, Netsanet Tsegai, Lauren Sterlin, Ulcha F. Ulysse, Imani Boykin, K. Sine, Oyin Alao, Jacqueline Lucia, E. Lander, T. Golub
{"title":"Abstract OT-18-01: The metastatic breast cancer project: Generating the clinical and genomic landscape of metastatic breast cancer through patient-partnered research","authors":"N. Wagle, C. Painter, E. Anastasio, Michael Dunphy, Mary McGillicuddy, Esha Jain, Brett N. Tomson, Tania G. Hernandez, Beena S. Thomas, Dewey Kim, Alyssa L. Damon, Shahrayz Shah, Rafael Ramos, Colleen M. Nguyen, Lee O'Neil, S. Winnicki, Sara Balch, Rachel E. Stoddard, T. Cusher, P. Chastain, J. G. T. Zañudo, Jorge E. Buendia-Buendia, Ofir Cohen, Netsanet Tsegai, Lauren Sterlin, Ulcha F. Ulysse, Imani Boykin, K. Sine, Oyin Alao, Jacqueline Lucia, E. Lander, T. Golub","doi":"10.1158/1538-7445.sabcs20-ot-18-01","DOIUrl":"https://doi.org/10.1158/1538-7445.sabcs20-ot-18-01","url":null,"abstract":"","PeriodicalId":342683,"journal":{"name":"Ongoing Clinical Trials Abstracts","volume":"11 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123670205","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-02-15DOI: 10.1158/1538-7445.sabcs20-ot-13-07
J. Specht, D. Maloney, C. Yeung, Q. Wu, C. Bamdad
{"title":"Abstract OT-13-07: Phase I study of adoptive immunotherapy for advanced MUC1* positive breast cancer with autologous T cells engineered to express a chimeric antigen receptor, huMNC2-CAR44 specific for a cleaved form of MUC1 (MUC1*)","authors":"J. Specht, D. Maloney, C. Yeung, Q. Wu, C. Bamdad","doi":"10.1158/1538-7445.sabcs20-ot-13-07","DOIUrl":"https://doi.org/10.1158/1538-7445.sabcs20-ot-13-07","url":null,"abstract":"","PeriodicalId":342683,"journal":{"name":"Ongoing Clinical Trials Abstracts","volume":"75 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125145623","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-02-15DOI: 10.1158/1538-7445.sabcs20-ot-12-01
Laura A. Lee, S. Diab, J. Barone, J. Crozier, Margret Chen, Rakshanda L Rahman, R. Maganini, D. Marks, A. Truitt, L. Blumencranz, E. Yoder, S. Untch, W. Audeh, Bastiaan van der Baan
{"title":"Abstract OT-12-01: The FLEX real-world data platform explores new gene expression profiles and investigator-initiated protocols in early stage breast cancer","authors":"Laura A. Lee, S. Diab, J. Barone, J. Crozier, Margret Chen, Rakshanda L Rahman, R. Maganini, D. Marks, A. Truitt, L. Blumencranz, E. Yoder, S. Untch, W. Audeh, Bastiaan van der Baan","doi":"10.1158/1538-7445.sabcs20-ot-12-01","DOIUrl":"https://doi.org/10.1158/1538-7445.sabcs20-ot-12-01","url":null,"abstract":"","PeriodicalId":342683,"journal":{"name":"Ongoing Clinical Trials Abstracts","volume":"29 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126749705","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-02-15DOI: 10.1158/1538-7445.sabcs20-ot-09-07
Brandon Lau, D. Segara, Andrew Ong, Janne Bingham, B. Kiely, Emma Carson, Julia Chen, C. Mak, S. Warrier, M. Hui, K. Middleton, A. Parker, B. Mann, G. Lindeman, Wayne Tilley, E. Lim
{"title":"Abstract OT-09-07: Winpro: A window of opportunity study of endocrine therapy with and without prometrium in postmenopausal women with early stage hormone receptor-positive breast cancer","authors":"Brandon Lau, D. Segara, Andrew Ong, Janne Bingham, B. Kiely, Emma Carson, Julia Chen, C. Mak, S. Warrier, M. Hui, K. Middleton, A. Parker, B. Mann, G. Lindeman, Wayne Tilley, E. Lim","doi":"10.1158/1538-7445.sabcs20-ot-09-07","DOIUrl":"https://doi.org/10.1158/1538-7445.sabcs20-ot-09-07","url":null,"abstract":"","PeriodicalId":342683,"journal":{"name":"Ongoing Clinical Trials Abstracts","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130116138","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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