Ongoing Clinical Trials最新文献

{"title":"Abstract OT2-06-02: Chemokine modulation to enhance the effectiveness of pembrolizumab in patients with metastatic triple negative breast cancer","authors":"Y. Abdou, L. Williams, P. Kalinski, M. Opyrchal","doi":"10.1158/1538-7445.SABCS18-OT2-06-02","DOIUrl":"https://doi.org/10.1158/1538-7445.SABCS18-OT2-06-02","url":null,"abstract":"","PeriodicalId":19476,"journal":{"name":"Ongoing Clinical Trials","volume":"27 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88910966","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}

{"title":"Abstract OT1-01-05: Endocrine treatment alone as primary treatment for elderly patients with estrogen receptor positive good prognosis operable breast cancer: A single arm phase II, single institution study","authors":"R. Aft, M. Cherian, A. Frith, R. Suresh, K. Glover-Collins, M. Naughton, C. Moon, L. Conant, Cynthia X. Ma","doi":"10.1158/1538-7445.SABCS18-OT1-01-05","DOIUrl":"https://doi.org/10.1158/1538-7445.SABCS18-OT1-01-05","url":null,"abstract":"Background : It is estimated that approximately 46,000 women age >75 are diagnosed annually with breast cancer. Due to competing co-morbidities, there is wide variation in treatment recommendations which can lead to over- or under-treatment. Though surgery for breast cancer is considered low-morbidity, many elderly women given a choice, choose not to have surgery. Previous randomized trials comparing surgery with tamoxifen versus endocrine therapy alone in women age >70 unselected for ER status demonstrated similar overall survival with poorer local control in the latter group. A new standard of care needs to be defined for elderly women with good prognosis ER+ tumors, since these women may benefit from endocrine therapy alone to treat their cancer without compromising local and distant control. Hypothesis : We hypothesize that endocrine therapy alone provides adequate local and systemic control of breast cancer in a subpopulation of women age 70 or older with ER+ breast cancer and good prognostic characteristics. Primary Objective To correlate response to neoadjuvant endocrine treatment at 6 months with Oncotype DX Recurrence Score ( RS ) in women with early-stage ER+ breast cancer who are age >70. Secondary Objective 1. To determine the breast cancer-specific survival of women with early-stage ER+ breast cancer, age >70, treated with endocrine therapy alone. 2. To determine the rate of overall survival of women with early-stage ER+ breast cancer, age >70 treated with endocrine therapy alone. Study Design : This is a prospective single arm phase II study. Patients with clinical stage I/II ER+ breast cancer, grade 1-2, Ki67 Results : Between February 2017 and April 2018, 11 patients were enrolled into the study. Two patients could not tolerate endocrine therapy and received standard of care treatment. For the 9 patients on study, average tumor size was 1.7cm, average Ki67 was 15%, average RS was 14. All of the patients received an aromatase inhibitor. At 6 months, 71% of the patients had a partial response, 28% had stable disease. None of the patients developed progressive disease. Conclusion : A new standard of care needs to be defined for women age >70 with good prognosis ER+ tumors, since these women may benefit from endocrine therapy alone to treat their cancer without compromising local and distant control. We continue to enroll patients to determine the optimal tumor markers for identifying women who can be treated with PET only to control their cancer. Citation Format: Aft R, Cherian M, Frith A, Suresh R, Glover-Collins K, Naughton M, Moon C, Conant L, Ma C. Endocrine treatment alone as primary treatment for elderly patients with estrogen receptor positive good prognosis operable breast cancer: A single arm phase II, single institution study [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr OT1-01-05.","PeriodicalId":19476,"journal":{"name":"Ongoing Clinical Trials","volume":"2 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89684037","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}

{"title":"Abstract OT3-02-08: Genetic analysis in blood, urine, stool and tumor samples from patients with advanced or metastatic estrogen receptor positive and HER2 negative breast cancer receiving palbociclib and endocrine therapy (PROMISE)","authors":"C. O'Sullivan, V. Suman, Krishna R. Kalari, A. Moyer, J. Sung, A. Moreno-Aspitia, D. Northfelt, M. Liu, T. Haddad, S. Chumsri, F. Couch, R. Weinshilboum, Liewei Wang, M. Goetz","doi":"10.1158/1538-7445.sabcs18-ot3-02-08","DOIUrl":"https://doi.org/10.1158/1538-7445.sabcs18-ot3-02-08","url":null,"abstract":"","PeriodicalId":19476,"journal":{"name":"Ongoing Clinical Trials","volume":"8 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88453683","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}

{"title":"Abstract OT3-03-01: Open-label, single-arm study evaluating the antitumor activity and safety of niraparib as neoadjuvant treatment in patients with localized,HER2-negative,BRCA-mutant breast cancer","authors":"H. Han, E. Hamilton, H. Irie, S. Isakoff, D. Jelovac, A. Liem, Minetta C. Liu, A. Milillo, J. Nangia, D. Page, J. Reeves, C. Santa-Maria, M. Duncan, J. Graham, J. Chen, B. Dezube, Laura M. Spring","doi":"10.1158/1538-7445.SABCS18-OT3-03-01","DOIUrl":"https://doi.org/10.1158/1538-7445.SABCS18-OT3-03-01","url":null,"abstract":"","PeriodicalId":19476,"journal":{"name":"Ongoing Clinical Trials","volume":"11 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85426297","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}

{"title":"Abstract OT1-09-01: Phase II trial assessing accuracy of tumor bed biopsies in predicting pathologic response in patients with clinical/radiological complete response after neoadjuvant chemotherapy in order to explore the feasibility of breast-conserving surgery without surgery: NRG Oncology BR005","authors":"M. Basik, JP Costantino, J. D. Santos, H. Umphrey, T. Julian, E. Mamounas, J. White, P. C. Lucas, J. Wagner, J. Tjoe, A. Thompson, N. Wolmark","doi":"10.1158/1538-7445.sabcs18-ot1-09-01","DOIUrl":"https://doi.org/10.1158/1538-7445.sabcs18-ot1-09-01","url":null,"abstract":"The increased use of neoadjuvant chemotherapy (NCT) has enabled higher rates of breast-conserving surgery (BCS) as well as provided prognostic information for women with breast cancer. High pathological complete response (pCR) rates question the requirement for surgery, with its attendant morbidity. In order to avoid surgery, the ability to predict pCR prior to it must be very high. Trimodality imaging alone is inadequate to predict pCR prior to surgery. We hypothesize that performing core-needle biopsy (bx) of the tumor bed in addition to trimodality imaging in patients (pts) having had a clinical complete response (cCR) will increase the ability to predict pCR. Utilizing predetermined imaging response criteria of complete or near-complete response coupled with a stereotactic core-needle bx of the tumor bed, BR005 aims to determine the predictive value of imaging followed by tumor bed bx for pCR and demonstrate its reproducibility across a multi-institutional setting. Methods: 175 pts with operable focal or multifocal (T1-T3), stage II/IIIA invasive ductal carcinoma (all receptor subtypes) will be entered. Pts must have completed a minimum of 8 wks of standard NCT and achieved a complete or near-complete radiologic tumor response on breast imaging with mammogram, ultrasound, and MRI, and undergo BCS. Following cCR and prior to surgery, pts will undergo a stereotactic-vacuum-assisted breast bx with clip placement. The primary endpoint is the proportion of pts with post-NCT neg image-directed bx who have a pCR. Residual cancer burden scores and core bx pathology will be collected along with trimodality imaging data. Evaluation after 135 pts will allow for the possibility of early termination of the study. Results will provide the first step toward a paradigm change in the treatment of breast cancer, enabling a study to assess the criteria for successful avoidance of surgery in pts with high response rates to NCT. Accrual as of 6-15-18: 39 (22.3%). Support: U10CA180868, -180822, UG1CA189867. Citation Format: Basik M, Costantino JP, De Los Santos JF, Umphrey HR, Julian TB, Mamounas EP, White JR, Lucas PC, Wagner JL, Tjoe JA, Thompson AM, Wolmark N. Phase II trial assessing accuracy of tumor bed biopsies in predicting pathologic response in patients with clinical/radiological complete response after neoadjuvant chemotherapy in order to explore the feasibility of breast-conserving surgery without surgery: NRG Oncology BR005 [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr OT1-09-01.","PeriodicalId":19476,"journal":{"name":"Ongoing Clinical Trials","volume":"150 5 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83148550","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}

{"title":"Abstract OT1-11-02: PRAEGNANT - Real world evidence, translational research, big and smart data: A prospective academic translational research network for the optimization of the oncological health care quality in the adjuvant and advanced/ metastatic setting (NCT02338167)","authors":"V. Müller, J. Huober, B. Volz, F. Overkamp, H. Kolberg, P. Hadji, L. Haeberle, J. Ettl, A. Hartkopf, M. Lux, D. Lüftner, M. Wallwiener, F. Taran, M. Beckmann, E. Belleville, P. Wimberger, C. Hielscher, M. Geberth, J. Lermann, A. Abenhardt, C. Kurbacher, R. Wuerstlein, C. Thomssen, M. Untch, W. Janni, T. Fehm, S. Brucker, D. Wallwiener, A. Schneeweiss, P. Fasching, H. Tesch","doi":"10.1158/1538-7445.sabcs18-ot1-11-02","DOIUrl":"https://doi.org/10.1158/1538-7445.sabcs18-ot1-11-02","url":null,"abstract":"","PeriodicalId":19476,"journal":{"name":"Ongoing Clinical Trials","volume":"84 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81149764","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}

{"title":"Abstract OT1-05-05: REASSURE- Effects of Reiki as supportive treatment during chemotherapy of breast cancer: A prospective, randomized, controlled clinical trial","authors":"S. Katzendobler, L. Haunreiter, L. Zander, R. Schmidt, A. Andrulat, K. Münch, C. Hanusch, R. Napieralski, I. Petri, J. Ettl","doi":"10.1158/1538-7445.SABCS18-OT1-05-05","DOIUrl":"https://doi.org/10.1158/1538-7445.SABCS18-OT1-05-05","url":null,"abstract":"Background: Every seventh to eighth woman is diagnosed with breast cancer in her life. Next to surgery and radiotherapy most of them receive (neo)adjuvant chemotherapy, which comes along with adverse effects. Complementary and alternative medicine (CAM) like Reiki can reduce these effects. Reiki is a Far Eastern method that promotes healing on a physical, mental and emotional level and activates self-healing powers. REASSURE examines the effects of Reiki on quality of life and taxane-induced polyneuropathy during chemotherapy. Methods: REASSURE is a prospective, randomized, controlled, two-armed clinical trial, in which patients with breast cancer receive chemotherapy and Reiki (18 times) or chemotherapy and sport (18 times). During chemotherapy and before and after every Reiki- or sport-session the patients fill out standardized questionnaires (e.g. FACT/GOG-NTX Version 4). Primary endpoint is the comparison of quality of life at the end of chemotherapy between Reiki and sport based on the FACT/GOG-NTX score by T-Test. Secondary endpoint is the comparison of the taxane-induced polyneuropathy at the end of chemotherapy between the two groups. Also short-term effects before and after the Reiki- and sport-session will be examined. A power of 1-β = 0.8, a bilateral probability of error of α = 0.05, a minimum relevant difference deltaθ = 4 and a pooled standard deviation of 11 for the two-sided T-Test result in case numbers of 2 x 120 = 240 patients. Conclusion: REASSURE is the most comprehensive prospective study to the effects and the feasibility of Reiki on breast cancer patients during chemotherapy so far. Since July 2015, 138 patients have been enrolled at three different centers. Currently 63 patients in total (39 patients of the Reiki-group and 24 patients of the sport-group) have completed the study. 24 Reiki-patients and 36 sport-patients are counted as dropouts because of reasons like incomplete data records, discontinuation of chemotherapy, not enough time or energy for Reiki- or sport-sessions or other reasons. Sponsor: This is a collaborative study of the Department of Obstetrics and Gynecology, Klinikum rechts der Isar, Technische Universitat Munchen (TUM), Munich, Germany, Rotkreuzklinikum Munchen, Frauenklinik, Munich, Germany, Department of Gynaecology, Stadtisches Klinikum Munchen Harlaching, Munich, Germany and the ProReiki – der Berufsverband e.V., Berlin, Germany. Contact Information: For further information contact Sophie Katzendobler via sophie.katzendobler@gmail.com or the leading physician Dr. Johannes Ettl via johannes.ettl@tum.de. Citation Format: Katzendobler S, Haunreiter L, Zander L, Schmidt R, Andrulat A, Munch K, Hanusch C, Napieralski R, Petri I, Ettl J. REASSURE- Effects of Reiki as supportive treatment during chemotherapy of breast cancer: A prospective, randomized, controlled clinical trial [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA):","PeriodicalId":19476,"journal":{"name":"Ongoing Clinical Trials","volume":"305 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91447222","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}

{"title":"Abstract OT3-04-02: Neoadjuvant Her2-targeted therapy +/- immunotherapy with pembrolizumab (neoHIP): An open label randomized phase II trial","authors":"H. McArthur, J. Leal, D. Page, C. Abaya, R. Basho, Lindsey Ristow, H. Coleman, S. Shiao, S. Knott, M. Mita, M. Tighiouart, A. Chung, F. Dadmanesh, P. McAndrew, S. Karlan, S. Verma, A. Giuliano","doi":"10.1158/1538-7445.SABCS18-OT3-04-02","DOIUrl":"https://doi.org/10.1158/1538-7445.SABCS18-OT3-04-02","url":null,"abstract":"Background: In preclinical models HER2-directed therapy administered with checkpoint blockade is synergistic. Clinically, trastuzumab administered with pembrolizumab-mediated checkpoint blockade in trastuzumab-resistant HER2-positive metastatic breast cancer was safe and demonstrated modest activity. However, because checkpoint blockade can confer improved responses when administered earlier in the course of disease, trastuzumab with pembrolizumab administered in the curative-intent, treatment-naive setting may confer life-long, tumor-specific immunity and ultimately, improve cure rates. Moreover, the potential synergy of trastuzumab and pembrolizumab with paclitaxel may overcome the need for dual HER2-blockade. The neo-HIP study is a randomized, multicenter, phase II, open-label trial to evaluate the efficacy and safety of weekly paclitaxel, trastuzumab plus pertuzumab (THP) vs weekly THP plus pembrolizumab (THP-K) vs a HER2 monotherapy regimen (TH-K) as neoadjuvant treatment in patients with HER2-positive early stage invasive breast cancer. Methods:Patients ≥18 years old with previously untreated, non-metastatic, stage II-III, HER2-positive (by ASCO/CAP guidelines) breast cancer are eligible. Patients with inflammatory breast cancer or bilateral primary tumors are excluded. Adequate organ function and ECOG PS 0-1 are required. Approximately 174 patients will be randomly assigned to 1 of 3 arms with stratification by clinical nodal status (positive vs. negative) and hormone receptor status (positive vs. negative). In arm A, patients will receive T at 80mg/m2 weekly for 12 weeks, H at 8mg/Kg (1 loading dose) and then 6mg/Kg IV every 3 weeks x 3 doses, P at 840mg (1 loading dose) and then 420mg/Kg IV every 3 weeks x 3 doses (THP). In arm B, patients will receive the same regimen as arm A with the addition of pembrolizumab 200mg IV every 3 weeks x 4 doses (THP-K). In arm C, patients will receive the same regimen as arm B, but without pertuzumab (TH-K). Definitive surgery will be 3-6 weeks after the last treatment dose. After surgery, patients in all arms willbe treated per the treating physician9s discretion. After completion of post-operative chemotherapy, patients will receive radiotherapy per local clinical standard and those patients whose tumors are hormone-receptor positive will receive hormone therapy as per local standard-of-care. The purpose of this phase II study is to identify whether Arm B (THP-K) and/or Arm C (TH-K) demonstrate a clinically significant improvement in pCR rate when compared with Arm A (THP). The primary end point is pCR rate in the breast and axilla (ypT0/Tis ypN0). Secondary end points include pCR rate by ypT0ypN0 and ypT0/Tis, residual cancer burden index, event free survival, breast conserving surgery rate, safety and overall survival. Exploratory correlative studies will characterize the immunologic responses to the interventions and explore potential predictors of efficacy and toxicity. Citation Format: McArthur HL","PeriodicalId":19476,"journal":{"name":"Ongoing Clinical Trials","volume":"119 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77752970","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}

{"title":"Abstract OT2-04-02: A phase 3 study of post-lumpectomy radiotherapy to whole breast + regional lymph nodes vs whole breast alone for patients with pN1 breast cancer treated with taxane-based chemotherapy (KROG 1701): Trial in progress","authors":"Hyunyou Kim, W. Park, D. Choi, S. Ahn, S. Kim, E. Kim, Jong-Ho Lee, Kc Lee, Juyeon Kim, H. Lee, M-Y Kim, H. Park, Kim Myung-Suk Kim, Shi-Jian Song, J. Kwon, I. Lee, T. Kim, Tg Kim, A. Chang, O. Cho, B. Jeong, B. Ha, J.-Y. Lee, Y. Ki","doi":"10.1158/1538-7445.SABCS18-OT2-04-02","DOIUrl":"https://doi.org/10.1158/1538-7445.SABCS18-OT2-04-02","url":null,"abstract":"Background In patients with early stage breast cancer, regional nodal irradiation (RNI) is added to whole breast irradiation (WBI) in order to control microscopic regional disease and to prevent systemic spread of cancer. According to recent randomized trials (MA.20 and EORTC 22922-10925), prophylactic RNI was associated with improvement in disease-free survival (DFS) in the patients with high-risk node negative or pN1 breast cancer. However, systemic agents now known to improve loco-regional control, such as taxane or endocrine therapy, were prescribed to a small percentage of patients in the studies. The benefit of RNI found in the previous studies might be attributed to incorporation of less effective systemic treatments. The impact of prophylactic RNI in pN1 breast cancer should be evaluated in the patients receiving modern systemic treatment. The current study was conducted to compare the effect of post-lumpectomy WBI vs WBI plus RNI on DFS in pN1 breast cancer patients who received adjuvant taxane-based chemotherapy. Methods This study is a multicenter, phase 3, randomized controlled non-inferiority trial (NCT03269981). Eligibility criteria are ≥ 20 years female; pathologically proven invasive carcinoma of the breast; one to three positive axillary lymph nodes (pN1) in pathologic specimen; receiving breast-conserving surgery followed by taxane-based chemotherapy; having adjuvant endocrine therapy or anti-HER2 treatment according to molecular subtype of tumor. Patients are randomly assigned in a 1:1 ratio to receive WBI or WBI plus RNI. Patient randomization was stratified by molecular subtype of tumor (i.e. luminal A/luminal B/luminal HER2/HER2-enriched/triple-negative) and methods of axillary management (i.e. sentinel lymph node biopsy/axillary lymph node dissection). The primary outcome is DFS. The secondary outcomes include DFS according to molecular subtype, treatment-related toxicity, and patient9s quality of life per EORTC QLQ-C30 and QLQ-BR23. Patients will be followed for survival and disease recurrence for seven years. A total of 1,926 patients are planned to be enrolled, with recruitment initiated in April 2017. As of June 2018, a total of 236 patients were enrolled. Acknowledgement This study was supported by a grant from the National RD 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr OT2-04-02.","PeriodicalId":19476,"journal":{"name":"Ongoing Clinical Trials","volume":"142 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80171197","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}

{"title":"Abstract OT2-05-02: International retrospective cohort study of locoregional and systemic therapy in oligometastatic breast cancer (OLIGO-BC1)","authors":"S. Imoto, M. Futamura, M. Toi, Y. Fujiwara, T. Ueno, Y. Im, S. Im, S. Ahn, J. Lee, Yong-Hee Park, K. Wang, Y. Kitagawa, M. Nishiyama","doi":"10.1158/1538-7445.SABCS18-OT2-05-02","DOIUrl":"https://doi.org/10.1158/1538-7445.SABCS18-OT2-05-02","url":null,"abstract":"Breast cancer (BC) is so-called “systemic disease”, because disseminated cancer cells in bone marrow and blood are detected even in early BC patients. Despite adjuvant therapy and postoperative radiation therapy, patients with triple negative BC and Luminal B-like BC often relapse early and systemic therapy is the only way to control disease progression. On the other hand, some BC patients relapse several years later. In such patients, oligometastases are occasionally diagnosed, because metastatic cancer cells are slowly growing and indolent. Oligometastatic BC is defined as low volume metastatic disease with limited number and size of metastatic lesions (up to five and not necessarily in the same organ). This definition is proposed in the Advanced Breast Cancer guidelines that are developed as a joint effort from European School of Oncology and European Society of Medical Oncology. Several retrospective studies demonstrated survival benefit of locoregional therapy in addition to systemic therapy. Locoregional therapy consisted of surgical resection, radiation therapy, ablation therapy, etc. However, it remains unclear about survival benefit of combined therapy in oligometastatic BC. To improve the standard of cancer treatment through the cooperate studies on more effective therapeutic strategies based on drugs, surgery and/or radiotherapy, Federation of Asian Clinical Oncology (FACO) was established in 2012 by Chinese Society of Clinical Oncology (CSCO), Korean Society of Medical Oncology (KSMO) and Japan Society of Clinical Oncology (JSCO). Thus, FACO conducted a retrospective cohort study on oligometastatic BC. The primary endpoint is to compare the estimated 5-year overall survival (OS) of oligometastatic BC patients treated with combined therapy and systemic therapy alone. To hypothesize that combined therapy has more advantage of OS in oligometastatic BC, the 5-year OS rates are expected to be 50% and 40%, respectively. The estimated sample size is calculated to be the number of 698 cases (349 cases in each group) needed to prove the superiority of survival with a two-sided type I error rate of 5% and a statistical power of 80%. Case registry opened in February 2018 and will close in January 2019. We planned to register 700 cases, i.e., 234 cases each from investigators of CSCO, KSMO and JSCO. Update information will be discussed. Citation Format: Imoto S, Futamura M, Toi M, Fujiwara Y, Ueno T, Im Y-H, Im S-A, Ahn SG, Lee JE, Park YH, Wang K, Kitagawa Y, Nishiyama M. International retrospective cohort study of locoregional and systemic therapy in oligometastatic breast cancer (OLIGO-BC1) [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr OT2-05-02.","PeriodicalId":19476,"journal":{"name":"Ongoing Clinical Trials","volume":"44 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83705614","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}