Ongoing Clinical Trials最新文献

{"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 OT2-02-01: A confirmation study of omitting axillary dissection in patients with breast cancer and positive sentinel nodes","authors":"N. Jibiki, A. Hirano, T. Ochi, Akiko Sakamoto, Kiyomi Horiuchi, Eiichiro Noguchi, Yoko Omi, K. Ogura, H. Inoue, T. Kamio, Y. Naritaka, M. Fujibayashi, K. Hiroshima, Y. Nagashima, S. Sakai, K. Karasawa, T. Okamoto","doi":"10.1158/1538-7445.SABCS18-OT2-02-01","DOIUrl":"https://doi.org/10.1158/1538-7445.SABCS18-OT2-02-01","url":null,"abstract":"","PeriodicalId":19476,"journal":{"name":"Ongoing Clinical Trials","volume":"26 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81732529","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 OT2-07-07: Image-guided de-escalation of neoadjuvant chemotherapy in HER2-positive breast cancer: The TRAIN-3 study","authors":"A. V. D. Voort, V. Dezentjé, WA van der Steeg, Gonneke A. O. Winter-Warnars, R. Schipper, A. Scholten, J. Wesseling, E. Werkhoven, F. Duijnhoven, M. Peeters, G. Sonke","doi":"10.1158/1538-7445.SABCS18-OT2-07-07","DOIUrl":"https://doi.org/10.1158/1538-7445.SABCS18-OT2-07-07","url":null,"abstract":"Background The addition of pertuzumab to trastuzumab containing chemotherapy has boosted pathologic complete response (pCR) rates after neoadjuvant chemotherapy for HER2-positive breast cancer. PCR rates over 80% have been described and achieving a pCR is associated with a favorable long-term outcome. In addition, achieving a radiologic complete response (rCR) is predictive of the pathologic response in HER2-positive tumors. Therefore it is hypothesized that image-guided evaluation based on the early occurrence of rCR can be used to tailor the number of chemotherapy cycles. Trial design This is a single arm, multicenter study evaluating the efficacy of image-guided de-escalation of neoadjuvant treatment with paclitaxel, Herceptin®, carboplatin, and pertuzumab (PTC-ptz). Radiologic evaluation with contrast-enhanced breast MRI and ultrasound of the axilla (in cN+ patients) is performed at baseline and after 3, 6, and 9 cycles of treatment. In case of rCR of the breast (and axilla) after 3 or 6 cycles, early surgery will be performed. If residual tumor is present after 3 and 6 cycles, patients will continue the PTC-ptz regimen to complete a total of 9 cycles. All patients will receive adjuvant Herceptin® and pertuzumab to complete 1 year of anti-HER2 blockade and endocrine treatment according to local guidelines if HR-positive. The study will be performed in the Netherlands in approximately 35 centers. Eligibility criteria Eligible patients have histologically proven stage II/III HER2-positive primary breast cancer with known hormone-receptor status. Patients must have a measurable breast tumor on baseline MRI and can be either node negative or node positive. Specific aims The aim is to evaluate the efficacy of image-guided de-escalation of neoadjuvant chemotherapy in HER2-positive breast cancer on event-free survival (EFS) at 3 years as primary endpoint. Secondary endpoints are overall survival, rCR, concordance between rCR and pCR (ypT0/is, ypN0), differences in EFS and OS following pCR between patients who received 3, 6, or 9 cycles, and toxicity. Statistical methods This is a single-arm, two stage study with one interim-analysis and a final analysis. Statistics will be performed for each hormone receptor subgroup separately. Stopping rules are based on 3-year EFS-rates described in literature (88% for HR-negative tumors and 90% for HR-positive tumors) and calculated using the exact conditional Poisson distribution. The study is successful with ≤34 EFS-events in the HR-negative subgroup and ≤38 events in the HR-positive subgroup after 700 patient-years of follow-up. The three-year EFS-estimate will be calculated using Kaplan-Meier statistics. Present accrual and target accrual Target accrual is 231 patients for the HR-negative group and 231 patients for the HR-positive group. Present accrual will follow. Funding Investigator initiated trial sponsored by the Dutch Breast Cancer Research Group (BOOG), funded by Roche. Contact information for people","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":"81472305","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 OT1-13-01: MammaPrint, BluePrint, and full-genome data linked with clinical data to evaluate new gene expression profiles (FLEX)","authors":"A. Brufsky, J. Crozier, I. Grady, T. Lomis, P. Whitworth, E. Rehmus, G. Srkalović, Ll Lee, P. Blumencranz, P. Baron, B. Mavromatis, S. Untch, L. Blumencranz, E. Yoder, W. Audeh","doi":"10.1158/1538-7445.sabcs18-ot1-13-01","DOIUrl":"https://doi.org/10.1158/1538-7445.sabcs18-ot1-13-01","url":null,"abstract":"","PeriodicalId":19476,"journal":{"name":"Ongoing Clinical Trials","volume":"50 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88357192","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 OT1-01-04: Phase 1 study of D-0502, an orally bioavailable SERD with optimized pharmacological and PK/PD property for ER-positive breast cancer","authors":"Lianshan Zhang, D. Dai, Zhongcheng Shi, Jingting Jiang, Yungui Wang","doi":"10.1158/1538-7445.SABCS18-OT1-01-04","DOIUrl":"https://doi.org/10.1158/1538-7445.SABCS18-OT1-01-04","url":null,"abstract":"Background: Endocrine therapy such as selective estrogen receptor degrader (SERD) fulvestrant has been used effectively to extend the life of HR+ (ER+ and PR+) and HER2- breast cancer patient, either alone or in combination with CDK4/6 inhibitors such as palbociclib or abemaciclib. D-0502 is an orally bioavailable SERD with potent activity in various HR+ and HER2- breast cancer cell lines and xenograft models. Its combination with palbociclib in both MCF-7 xenograft model and ESR-1 mutated (Y537S) patient derived breast cancer xenograft models resulted in further tumor growth inhibition or regression. Drug metabolism and pharmacokinetic studies both in vitro and in vivo demonstrated that D-0502 exhibits favorable PK profiles suitable for clinical development. Trial Design: D-0502 is currently being evaluated in a phase 1 trial of women with advanced or metastatic HR+, HER2- breast cancer (MBC) (NCT03471663). This is a multicenter, open-label phase I study of D-0502 single agent and D-0502 in combination with standard dose of palbociclib. The primary objective is to characterize the safety and tolerability of D-0502 and D-0502 in combination with palbociclib, to identify an MTD and/or RP2D. The secondary objective is to evaluate the PK properties and the preliminary anti-tumor activities. Patients will receive D-0502 orally every day and treatment will be administered as 28-day cycles. The study has two parts: Dose Escalation (phase 1a) and Dose Expansion and Combination (phase 1b). In phase Ia, patients will be enrolled using a conventional dose-escalation algorithm (3+3 subjects per dose level) with 4 sequential dose cohorts to identify the MTD and RDE (recommended dose for expansion) in phase 1b) which will be at or below MTD. In phase 1b, there will be 2 cohorts, one is D-0502 single agent administered at RDE and the other is D-0502 in combination with standard dose of palbociclib, each with approximately 12 patients. Key Eligibility Criteria: Eligible patients included women with confirmed HR+, HER2- MBC who have previously received no more than 2 prior chemotherapies for MBC; ECOG 0-1; evaluable (phase 1a) or measurable (phase 1b) disease (RECIST v1.1); premenopausal or postmenopausal status; adequate hematologic, hepatic and renal functions. Current Status and Contact Information: At the time of abstract submission, the first cohort of 50 mg patients have started the study treatment. For inquiry of the study, please contact ling.zhang@inventisbio.com. Citation Format: Zhang L, Dai D, Shi Z, Jiang J, Wang Y. Phase 1 study of D-0502, an orally bioavailable SERD with optimized pharmacological and PK/PD property for ER-positive breast cancer [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 OT1-01-04.","PeriodicalId":19476,"journal":{"name":"Ongoing Clinical Trials","volume":"67 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85948120","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 OT3-01-01: BEGONIA: Phase Ib/II open-label, platform study of safety and efficacy of durvalumab, paclitaxel and other novel oncology therapy agents as first-line (1L) therapy in patients with metastatic triple negative breast cancer (mTNBC)","authors":"P. Schmid, At Nunes, R. Lall, C. D’Cruz, L. Grinsted, M. Lanasa","doi":"10.1158/1538-7445.SABCS18-OT3-01-01","DOIUrl":"https://doi.org/10.1158/1538-7445.SABCS18-OT3-01-01","url":null,"abstract":"Background: Immuno-oncology therapies have shown durable clinical responses in a subset of patients with mTNBC. Combination therapy with checkpoint inhibition and chemotherapy is under investigation; preliminary research showed improved objective response rate (ORR) with combination therapy versus chemotherapy alone.1 Durvalumab is a selective, high-affinity, engineered, human monoclonal antibody that blocks programmed cell death-ligand 1 (PD-L1) binding to programmed cell death 1 (PD-1) and CD80 allowing T cells to recognize and kill tumor cells. This study is designed to assess the efficacy and safety of durvalumab + paclitaxel as 1L treatment in patients with mTNBC. Additionally, this study will also evaluate potential novel triplet treatment regimens of durvalumab + paclitaxel in combination with immune-modulating agents, selumetinib (ARRY-142886; AZD6244, an inhibitor of mitogen activated protein kinase/extracellular signal regulated kinase [MAPK/ERK]), danvatirsen (AZD9150, an antisense oligonucleotide designed to down-regulate expression of signal transducer and activator of transcription 3 protein), oleclumab (MEDI9447, an anti-CD73 monoclonal antibody), and capivasertib (AZD5363, a highly selective, oral, small molecule AKT inhibitor) that may provide further benefit to patients with mTNBC. Methods: BEGONIA is a phase Ib/II, open-label, multicenter, platform study (EudraCT No: 2018-000764-29) consisting of 2 parts: Part 1 is a phase Ib study planned to be conducted in approximately 100 patients (20 per arm) to assess the safety and tolerability of durvalumab (1500 mg intravenous [IV], q4w) + paclitaxel (90 mg/m2 IV, 4 week cycle, 3 weeks once weekly [days 1, 8, 15], 1 week off) (arm 1); and durvalumab + paclitaxel in combination with selumetinib (arm 2), danvatirsen (arm 3), oleclumab (arm 4) and capivasertib (arm 5) until disease progression. Dosing of the immune-modulating agents will be based on the previously defined recommended phase 2 doses of the component doublets (where available) in combination with durvalumab + paclitaxel using a rolling 6-patient design to evaluate for toxicity. Part 2 is a phase II study planned to be conducted in approximately 150 to 225 patients to evaluate efficacy of up to 2 best triplet combination arms based on their safety and efficacy outcomes in Part 1. The primary objective of Part 1 is safety and of Part 2 is efficacy (primary endpoint: progression free survival [PFS]); additionally, efficacy will be assessed in both parts, including overall survival, ORR, PFS, and duration of response (RECIST 1.1). Immunotherapy naive adult patients (≥18 years) with locally assessed and confirmed TNBC, ECOG PS 0 or 1, stage IV breast adenocarcinoma and no prior systemic treatment for metastatic disease will be enrolled. 1Adams et al., J Clin Oncol 2016;34(Suppl):abstr 1009 Citation Format: Schmid P, Nunes AT, Lall R, D9Cruz C, Grinsted L, Lanasa MC. BEGONIA: Phase Ib/II open-label, platform study of safety and ef","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":"83433767","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 OT3-05-02: ALEXANDRA/IMpassion030: A phase III study of standard adjuvant chemotherapy with or without atezolizumab in early triple negative breast cancer","authors":"M. Ignatiadis, H. McArthur, A. Bailey, J-L Martinez, E. Azambuja, O. Metzger, C. Lai, N. Pondé, T. Goulioti, F. Daly, A. Bouhlel, V. Balta, V. V. Dooren, G. Viale, M. Maetens, C. Dufrane, A. Duc, E. Winer, R. Gelber, M. Piccart","doi":"10.1158/1538-7445.SABCS18-OT3-05-02","DOIUrl":"https://doi.org/10.1158/1538-7445.SABCS18-OT3-05-02","url":null,"abstract":"Background: Triple negative breast cancer (TNBC) is a subtype with a high risk of relapse in the early disease setting. Because TNBC does not currently have specific targeted agents approved for use in the early setting it is treated primarily with chemotherapy. A growing body of evidence indicates that TNBC is more immunogenic than other subtypes of breast cancer and promising clinical activity has been reported with atezolizumab (an anti–PD-L1 antibody) in Phase 1/1b metastatic TNBC trials. Furthermore, the anti-tumor activity of PD-1/PD-L1 targeting drugs is hypothesized to be enhanced when co-administered with chemotherapy. ALEXANDRA/IMpassion030 will evaluate the efficacy and safety of atezolizumab in combination with standard adjuvant chemotherapy in early TNBC. Methods: ALEXANDRA/IMpassion030 is a global, prospective, randomised, open-label Phase 3 trial investigating the efficacy, safety and pharmacokinetic (PK) profile of adjuvant atezolizumab plus standard chemotherapy versus chemotherapy alone in early TNBC. In total, 2300 patients diagnosed with non-metastatic operable stage II or III TNBC confirmed by central pathology review will be randomised. TumorPD-L1evaluationwill be performed centrally. Patients will be stratified by type of surgery, nodal status, and PD-L1 status. The adjuvant treatment will consist of weekly paclitaxel 80 mg/m2 for 12 weeks followed by dose dense anthracycline (epirubicin 90 mg/m2 or doxorubicin 60 mg/m2) and cyclophosphamide 600 mg/m2 for 4 doses every 2 weeks or the same chemotherapy regimen (T-EC/AC) given concomitantly with atezolizumab 840 mg every 2 weeks followed by maintenance atezolizumab 1200 mg every 3 weeks until completion of 1 year of atezolizumab. Primary end-point is invasive disease-free survival (iDFS) and secondary end-points include iDFS by PD-L1 and lymph node status, overall survival, safety, patient functioning and health related quality of life (HRQoL). Tumour tissue and blood samples will be collected for biomarker research. The first site was activated in May 4th, and approximately 430 sites are expected to be open globally in 30 countries. This trial is sponsored by Roche and conducted in partnership with the Breast International Group, Frontier Science and Technology Research Foundation, Institute Jules Bordet and Alliance Foundation Trials. Clinicaltrials.gov NCT03498716. Citation Format: Ignatiadis M, McArthur H, Bailey A, Martinez J-L, De Azambuja E, Metzger O, Lai C, Ponde N, Goulioti T, Daly F, Bouhlel A, Balta V, Van Dooren V, Viale G, Maetens M, Dufrane C, Nguyen Duc A, Winer E, Gelber R, Piccart M. ALEXANDRA/IMpassion030: A phase III study of standard adjuvant chemotherapy with or without atezolizumab in early triple negative breast cancer [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 OT3-05-02.","PeriodicalId":19476,"journal":{"name":"Ongoing Clinical Trials","volume":"10 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84138580","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 OT2-07-08: Withdrawn","authors":"E. Paplomata, Virginia F. Borges, S. Loi, V. Abramson, E. Hamilton, S. Hurvitz, Nan Lin, L. Walker, R. Murthy","doi":"10.1158/1538-7445.sabcs18-ot2-07-08","DOIUrl":"https://doi.org/10.1158/1538-7445.sabcs18-ot2-07-08","url":null,"abstract":"","PeriodicalId":19476,"journal":{"name":"Ongoing Clinical Trials","volume":"117 6 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88467502","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 OT3-04-03: KEYNOTE-756: A randomized, double-blind, phase III study of pembrolizumab versus placebo in combination with neoadjuvant chemotherapy and adjuvant endocrine therapy for high-risk early-stage ER+/HER2–breast cancer","authors":"F. Cardoso, A. Bardia, F. André, D. Cescon, H. McArthur, M. Telli, S. Loi, J. Cortes, P. Schmid, N. Harbeck, C. Denkert, C. Jackisch, L. Jia, K. Tryfonidis, V. Karantza","doi":"10.1158/1538-7445.SABCS18-OT3-04-03","DOIUrl":"https://doi.org/10.1158/1538-7445.SABCS18-OT3-04-03","url":null,"abstract":"Background:Although ER+/HER2– breast cancer has a better overall prognosis than other breast cancer subtypes, there is a high-risk subpopulation characterized by high-grade tumors and decreased sensitivity to endocrine therapy, higher responsiveness to chemotherapy and worse prognosis. A large meta-analysis of prospective studies focusing on neoadjuvant chemotherapy (NAC) for treatment of stage I-III breast cancer demonstrated that increased pathologic complete response (pCR) rates at surgery were associated with improved survival. This correlation was observed across triple-negative breast cancer (TNBC), HER2+ breast cancer, and high-grade HR+/HER2- breast cancer. Specifically, patients with a pCR after NAC had a 5-year event-free survival (EFS) rate of 90%, whereas patients who did not achieve a pCR had a 5-year EFS rate of 60%.Therefore, increasing pCR rates after NAC may have a substantial impact for patients with high-risk early-stage HR+/HER2– breast cancer. KEYNOTE-756 is a global, randomized, double-blind, phase III study of pembrolizumab (vs placebo) + chemotherapy as neoadjuvant treatment, followed by pembrolizumab (vs placebo) plus endocrine therapy as adjuvant treatment for patients with high-risk, early-stage ER+/HER2– breast cancer. Methods: Patients with T1c-2 cN1-2 or T3-4 cN0-2 grade 3 or grade 2 with Ki-67 ≥30%, invasive, ductal ER+/HER2– breast cancerwill be stratified by lymph node involvement (positive vs negative), tumor PD-L1 status (positive vs negative), ER positivity (≥10% vs Citation Format: Cardoso F, Bardia A, Andre F, Cescon DW, McArthur H, Telli M, Loi S, Cortes J, Schmid P, Harbeck N, Denkert C, Jackisch C, Jia L, Tryfonidis K, Karantza V. KEYNOTE-756: A randomized, double-blind, phase III study of pembrolizumab versus placebo in combination with neoadjuvant chemotherapy and adjuvant endocrine therapy for high-risk early-stage ER+/HER2– breast cancer [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 OT3-04-03.","PeriodicalId":19476,"journal":{"name":"Ongoing Clinical Trials","volume":"57 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90962881","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 OT3-02-01: RIBANNA — Real-world evidence of ribociclib plus aromatase inhibitor, or endocrine monotherapy, or chemotherapy as first-line therapy for postmenopausal women with HR+, HER2– advanced breast cancer (aBC)","authors":"A. Wöckel, P. Fasching, G. Guderian, J. Heim, C. Jackisch, H. Lück, D. Lüftner, F. Marmé, T. Reimer, T. Decker","doi":"10.1158/1538-7445.SABCS18-OT3-02-01","DOIUrl":"https://doi.org/10.1158/1538-7445.SABCS18-OT3-02-01","url":null,"abstract":"Background: In the pivotal phase 3 MONALEESA-2 trial, ribociclib, a highly selective oral CDK4/6 inhibitor in combination with letrozole significantly prolonged progression-free survival (PFS) compared to letrozole alone. In the year 2017, based on the results of MONALEESA-2, ribociclib in combination with an aromatase inhibitor (AI) was approved for the treatment of HR+, HER2– aBC in postmenopausal women with no prior therapy for their advanced disease (first-line treatment). Beyond phase 3 trials, further data for ribociclib are now becoming available from the phase 3b trials, RIBECCA and COMPLEEMENT-1, involving approximately 500 and 3000 patients with aBC, respectively. However, real-world evidence for the effectiveness, safety, and tolerability of ribociclib + AI in the routine clinical practice is needed to further support the use of this combination in the first-line therapy. Methods: RIBANNA is a non-interventional study, which started in October 2017 and plans to enroll 3020 patients across ˜400 sites in Germany. Postmenopausal women diagnosed with aBC will be enrolled into 3 cohorts (cohort 1: ribociclib + AI; cohort 2: endocrine monotherapy; and cohort 3: chemotherapy). Across all cohorts, patients will be treated in accordance with the respective German-prescribing guidelines. Data related to efficacy (with PFS as the primary efficacy criterion), safety, tolerability, duration of therapy, and impact on quality of life (QoL) will be collected. QoL will be assessed using the validated patient questionnaires. This study was especially designed to analyze the patient data from sequential lines of therapy in all three cohorts over a period of up to 7 years. For this purpose, RIBANNA will collect the data on each line of treatment and the reason for changing treatment in all 3 cohorts. The same accounts for QoL, which will also be assessed periodically, regardless of disease progression and initiation of subsequent therapies. RIBANNA is the first study to provide the real-world evidence regarding treatment of HR+, HER2− aBC with the CDK4/6 inhibitor, ribociclib. This study includes 3 treatment cohorts (ribociclib + AI, endocrine monotherapy, and chemotherapy) with subsequent treatment algorithms and assessment of QoL over the entire study period. Citation Format: Wockel A, Fasching PA, Guderian G, Heim J, Jackisch C, Luck H-J, Luftner D, Marme F, Reimer T, Decker T. RIBANNA — Real-world evidence of ribociclib plus aromatase inhibitor, or endocrine monotherapy, or chemotherapy as first-line therapy for postmenopausal women with HR+, HER2– advanced breast cancer (aBC) [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 OT3-02-01.","PeriodicalId":19476,"journal":{"name":"Ongoing Clinical Trials","volume":"20 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83163541","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}