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RANDOMIZED CONTROLLED TRIAL
Wenjin Yin, Yaohui Wang, Ziping Wu, Yumei Ye, Liheng Zhou, Shuguang Xu, Yanping Lin, Yueyao Du, Tingting Yan, Fan Yang, Jie Zhang, Qiang Liu, Jinsong Lu
PURPOSE: Despite accumulating evidence on dual blockade of HER2 for locally advanced HER2-positive breast cancer, no robust evidence supports the addition of pyrotinib to trastuzumab in the neoadjuvant setting. The NeoATP trial aimed to evaluate the efficacy and safety of pyrotinib with neoadjuvant trastuzumab and chemotherapy. PATIENTS AND METHODS: The phase II NeoATP trial included female patients with histologically confirmed stage IIA to IIIC and HER2-positive primary invasive breast cancer...
September 1, 2022: Clinical Cancer Research
#22
JOURNAL ARTICLE
Jens-Uwe Blohmer, Theresa Link, Mattea Reinisch, Marianne Just, Michael Untch, Oliver Stötzer, Peter A Fasching, Andreas Schneeweiss, Pauline Wimberger, Sabine Seiler, Jens Huober, Marc Thill, Christian Jackisch, Kerstin Rhiem, Christine Solbach, Claus Hanusch, Fenja Seither, Carsten Denkert, Knut Engels, Valentina Nekljudova, Sibylle Loibl
Importance: Adjuvant denosumab might improve disease-free survival in hormone receptor (HR)-positive primary breast cancer (BC). The optimal neoadjuvant nab-paclitaxel schedule in terms of efficacy and safety is unclear. Objective: To determine whether adding denosumab to anthracycline/taxane-containing neoadjuvant chemotherapy (NACT) increases the pathological complete response (pCR) rate and which nab-paclitaxel schedule is more effective in the NACT setting. Design, Setting, and Participants: The GeparX was a multicenter, prospective, open-label, phase 2b, 2 × 2 randomized clinical trial conducted by GBG and AGO-B at 38 German sites between February 2017 and March 2019...
May 19, 2022: JAMA Oncology
#23
JOURNAL ARTICLE
Madoka Ogikubo, Tatsuya Yoshida, Nobuyasu Suganuma, Akari Takahashi, Yasushi Rino, Munetaka Masuda
CASE: A 37-year-old pregnant woman arrived at our hospital with an abnormal mammogram. MEDICAL HISTORY: Mammography performed in June 2018 revealed an abnormal shadow on the left breast. Cytology from the 6-mm tumor in the left upper-outer quadrant revealed a malignancy. At the same time, a transvaginal echo revealed cysts, and the patient was diagnosed at 5 weeks gestation. Needle biopsy revealed a luminal A-like cStage Ⅰ, cT1bN0M0 invasive ductal carcinoma (IDC)...
April 2022: Gan to Kagaku Ryoho. Cancer & Chemotherapy
#24
RANDOMIZED CONTROLLED TRIAL
Ulrike Nitz, Oleg Gluz, Monika Graeser, Matthias Christgen, Sherko Kuemmel, Eva-Maria Grischke, Michael Braun, Doris Augustin, Jochem Potenberg, Katja Krauss, Claudia Schumacher, Helmut Forstbauer, Toralf Reimer, Andrea Stefek, Hans Holger Fischer, Enrico Pelz, Christine Zu Eulenburg, Ronald Kates, Rachel Wuerstlein, Hans Heinrich Kreipe, Nadia Harbeck
BACKGROUND: Several de-escalation neoadjuvant strategies have been investigated to reduce the use of chemotherapy in HER2-positive early breast cancer using pathological complete response as a surrogate endpoint; there are few survival data from these trials. Here, we report 5-year survival data in the WSG-ADAPT-HER2+/HR- trial and address the effect of pathological complete response, early therapy response, and molecular subtype. METHODS: WSG-ASAPT-HER2+/HR-, a part of the ADAPT umbrella trial performed in patients with different subtypes of early breast cancer, was an investigator-initiated, multicentre, open-label, randomised, phase 2 trial done at 40 Breast Cancer Centres in Germany...
May 2022: Lancet Oncology
#25
JOURNAL ARTICLE
Tamas Hickish, Ajay Mehta, Mei-Ching Liu, Chiun-Sheng Huang, Rajendra Singh Arora, Yuan-Ching Chang, Youngsen Yang, Vladimir Vladimirov, Minish Jain, Janice Tsang, Karine Pemberton, Behbood Sadrolhefazi, Xidong Jin, Ling-Ming Tseng
PURPOSE: Resistance to HER2 (ErbB2)-targeted therapy may be mediated by other members of the ErbB family. We investigated the efficacy and safety of the irreversible ErbB family blocker, afatinib, alone as first-line therapy in the advanced setting and in combination with vinorelbine or paclitaxel for those who progressed on afatinib monotherapy, in female patients with metastatic breast cancer who had failed or progressed on prior HER2-targeted therapy in the early disease setting. METHODS: In this phase II, single-arm, two-part study (ClinicalTrials...
February 9, 2022: Breast Cancer Research and Treatment
#26
RANDOMIZED CONTROLLED TRIAL
Rubi K Li, Eriko Tokunaga, Hryhoriy Adamchuk, Vladimir Vladimirov, Eduardo Yanez, Keun Seok Lee, Igor Bondarenko, Alicia Vana, Fiona Hilton, Tomofumi Ishikawa, Kentaro Tajima, Oleg Lipatov
BACKGROUND: PF-05280014 was compared with trastuzumab sourced from the European Union (trastuzumab-EU), each plus paclitaxel, as first-line treatment for human epidermal growth factor receptor 2-positive metastatic breast cancer in a phase III study. Equivalence between treatment groups was demonstrated. OBJECTIVE: The aim of this study was to report long-term safety and overall survival (OS) over 6 years after the first patient was screened. PATIENTS AND METHODS: Randomized patients received intravenous PF-05280014 or trastuzumab-EU, each plus paclitaxel, until objective disease progression...
January 2022: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
#27
JOURNAL ARTICLE
Jennifer R Bellon, Nabihah Tayob, David D Yang, Jordan Tralins, Chau T Dang, Steven J Isakoff, Michelle DeMeo, Harold J Burstein, Ann H Partridge, Eric P Winer, Ian E Krop, Sara M Tolaney
PURPOSE: Human epidermal growth factor receptor 2 (HER2)-directed therapy improves local control among women with HER2-positive breast cancer. This retrospective analysis evaluates the safety and efficacy of radiation therapy (RT) among patients receiving adjuvant trastuzumab emtansine (T-DM1) or paclitaxel (T) plus trastuzumab (H) in the ATEMPT (Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab) trial; TBCRC 033. METHODS AND MATERIALS: Patients with stage I HER2-positive breast cancer were randomized 3:1 to receive adjuvant T-DM1 or TH after mastectomy or breast-conserving surgery (BCS)...
January 3, 2022: International Journal of Radiation Oncology, Biology, Physics
#28
RANDOMIZED CONTROLLED TRIAL
Andreas Schneeweiss, Laura L Michel, Volker Möbus, Hans Tesch, Peter Klare, Eric Hahnen, Carsten Denkert, Karin Kast, Esther Pohl-Rescigno, Claus Hanusch, Theresa Link, Michael Untch, Christian Jackisch, Jens-Uwe Blohmer, Peter A Fasching, Christine Solbach, Rita K Schmutzler, Jens Huober, Kerstin Rhiem, Valentina Nekljudova, Kristina Lübbe, Sibylle Loibl
BACKGROUND: GeparOcto demonstrated that pathological complete response (pCR) of intense dose-dense epirubicin, paclitaxel and cyclophosphamide (iddEPC) was comparable to weekly paclitaxel/non-pegylated liposomal doxorubicin (plus carboplatin (PM(Cb) in triple-negative breast cancer [TNBC]) in high-risk early breast cancer (BC). Here, we report time-to-event secondary end-points. PATIENTS AND METHODS: Patients were randomised to receive 18 weeks of E (150 mg/m2 ) followed by P (225 mg/m2 ) followed by C (2000 mg/m2 ), each q2w or weekly P (80 mg/m2 ) plus M (20 mg/m2 ) plus, in TNBC, Cb (AUC 1...
January 2022: European Journal of Cancer
#29
JOURNAL ARTICLE
Omer Diker, Burak Yasin Aktas, Recep Ak, Bahadır Koylu, Onur Bas, Hakan Taban, Deniz Can Guven, Polat Olgun, Neyran Kertmen, Omer Dizdar, Berna Oksuzoglu, Sercan Aksoy
Background: In node-negative HER2 -overexpressed breast cancers, adjuvant paclitaxel plus trastuzumab treatment is a successful de-escalation approach with excellent survival outcomes. Methods: All patients with HER2+ breast cancer treated in our centers were retrospectively reviewed. Results: We analyzed 173 patients who were treated with adjuvant paclitaxel plus trastuzumab. The mean tumor size was 2.2 cm. There were eight invasive disease events or death: four distant recurrences (2.3%), three locoregional recurrences (1...
November 11, 2021: Future Oncology
#30
JOURNAL ARTICLE
Amy S Clark, Christina Yau, Denise M Wolf, Emanuel F Petricoin, Laura J van 't Veer, Douglas Yee, Stacy L Moulder, Anne M Wallace, A Jo Chien, Claudine Isaacs, Judy C Boughey, Kathy S Albain, Kathleen Kemmer, Barbara B Haley, Hyo S Han, Andres Forero-Torres, Anthony Elias, Julie E Lang, Erin D Ellis, Rachel Yung, Debu Tripathy, Rita Nanda, Julia D Wulfkuhle, Lamorna Brown-Swigart, Rosa I Gallagher, Teresa Helsten, Erin Roesch, Cheryl A Ewing, Michael Alvarado, Erin P Crane, Meredith Buxton, Julia L Clennell, Melissa Paoloni, Smita M Asare, Amy Wilson, Gillian L Hirst, Ruby Singhrao, Katherine Steeg, Adam Asare, Jeffrey B Matthews, Scott Berry, Ashish Sanil, Michelle Melisko, Jane Perlmutter, Hope S Rugo, Richard B Schwab, W Fraser Symmans, Nola M Hylton, Donald A Berry, Laura J Esserman, Angela M DeMichele
HER2-targeted therapy dramatically improves outcomes in early breast cancer. Here we report the results of two HER2-targeted combinations in the neoadjuvant I-SPY2 phase 2 adaptive platform trial for early breast cancer at high risk of recurrence: ado-trastuzumab emtansine plus pertuzumab (T-DM1/P) and paclitaxel, trastuzumab and pertuzumab (THP). Eligible women have >2.5 cm clinical stage II/III HER2+ breast cancer, adaptively randomized to T-DM1/P, THP, or a common control arm of paclitaxel/trastuzumab (TH), followed by doxorubicin/cyclophosphamide, then surgery...
November 5, 2021: Nature Communications
#31
JOURNAL ARTICLE
Eriko Tokunaga, Norikazu Masuda, Naohito Yamamoto, Hiroji Iwata, Hiroko Bando, Tomoyuki Aruga, Shoichiro Ohtani, Tomomi Fujisawa, Toshimi Takano, Kenichi Inoue, Nobuyasu Suganuma, Masahiro Takada, Kenjiro Aogi, Kenichi Sakurai, Hideo Shigematsu, Katsumasa Kuroi, Hironori Haga, Shinji Ohno, Satoshi Morita, Masakazu Toi
We conducted the Neo-LaTH study in which patients were randomized to different lengths of neoadjuvant induction anti-HER2 therapy with lapatinib and trastuzumab followed by weekly paclitaxel plus the anti-HER2 therapy, and in estrogen receptor (ER)-positive patients, with or without concurrent endocrine therapy. The use of endocrine therapy did not affect the response; comprehensive pathological complete response (CpCR) plus ypN0 rate was 57.6% and 30.3% in ER-negative and ER-positive patients, respectively...
August 9, 2021: Cancers
#32
JOURNAL ARTICLE
Xuexin He, Xiaolan Dai, Jiali Ji, Hong Liu, Ganggang Shi, Sai-Ching Jim Yeung
BACKGROUND: The combination of trastuzumab with anthracycline chemotherapy drugs is associated with synergistic cardiotoxicity. The aim of this study is to compare the efficacy and late-onset cardiac toxicity of neoadjuvant chemotherapy regimens, trastuzumab plus paclitaxel followed by 5-fluorouracil, epirubicin, and cyclophosphamide (PH-FECH) versus trastuzumab plus docetaxel and carboplatin (TCH), for human epidermal growth factor receptor 2-positive (HER2+ ) breast cancer (BC). METHODS: Patients with HER2+ BC who received neoadjuvant chemotherapy with PH-FECH or TCH between 2002 and 2009 at MD Anderson Cancer Center were included...
January 2022: Clinical Breast Cancer
#33
REVIEW
Misato Ogino, Takaaki Fujii, Yukio Koibuchi, Yuko Nakazawa, Daisuke Takata, Ken Shirabe
BACKGROUND/AIM: This phase II trial evaluated the efficacy and safety of neoadjuvant nab-paclitaxel plus cyclophosphamide (CPA) plus trastuzumab (AbraC-HER) in patients with early HER2-positive breast cancer. PATIENTS AND METHODS: This was a single-arm, open-label, single-center prospective phase II study. The primary endpoint was pathological complete response rate (pCR rate). The secondary endpoints were clinical antitumor efficacy and the frequency and severity of adverse events...
August 2021: Anticancer Research
#34
JOURNAL ARTICLE
D Miles, E Ciruelos, A Schneeweiss, F Puglisi, T Peretz-Yablonski, M Campone, I Bondarenko, Z Nowecki, H Errihani, S Paluch-Shimon, A Wardley, J-L Merot, P Trask, Y du Toit, C Pena-Murillo, V Revelant, D Klingbiel, T Bachelot
BACKGROUND: The phase III CLinical Evaluation Of Pertuzumab And TRAstuzumab (CLEOPATRA) trial established the combination of pertuzumab, trastuzumab and docetaxel as standard first-line therapy for human epidermal growth factor receptor 2 (HER2)-positive locally recurrent/metastatic breast cancer (LR/mBC). The multicentre single-arm PERtUzumab global SafEty (PERUSE) study assessed the safety and efficacy of pertuzumab and trastuzumab combined with investigator-selected taxane in this setting...
July 2, 2021: Annals of Oncology: Official Journal of the European Society for Medical Oncology
#35
REVIEW
Christian Jackisch, Patricia Cortazar, Charles E Geyer, Luca Gianni, Joseph Gligorov, Zuzana Machackova, Edith A Perez, Andreas Schneeweiss, Sara M Tolaney, Michael Untch, Andrew Wardley, Martine Piccart
Treatment of HER2-positive early breast cancer (EBC) continues to evolve with neoadjuvant (pre-operative) and adjuvant (post-operative) HER2-targeted therapies as standard of care. There are two important decision points. The first involves deciding between neoadjuvant therapy or proceeding directly to surgery. Neoadjuvant chemotherapy (NACT) plus pertuzumab-trastuzumab is appropriate for patients with high-risk HER2-positive EBC (tumour diameter ≥2 cm, and/or node-positive disease). Patients with node-negative disease and tumour diameter <2 cm are candidates for upfront surgery followed by paclitaxel for 12 weeks plus 18 cycles of trastuzumab, with the option to add pertuzumab (if pN+)...
May 20, 2021: Cancer Treatment Reviews
#36
RANDOMIZED CONTROLLED TRIAL
Sara M Tolaney, Nabihah Tayob, Chau Dang, Denise A Yardley, Steven J Isakoff, Vicente Valero, Meredith Faggen, Therese Mulvey, Ron Bose, Jiani Hu, Douglas Weckstein, Antonio C Wolff, Katherine Reeder-Hayes, Hope S Rugo, Bhuvaneswari Ramaswamy, Dan Zuckerman, Lowell Hart, Vijayakrishna K Gadi, Michael Constantine, Kit Cheng, Frederick Briccetti, Bryan Schneider, Audrey Merrill Garrett, Kelly Marcom, Kathy Albain, Patricia DeFusco, Nadine Tung, Blair Ardman, Rita Nanda, Rachel C Jankowitz, Mothaffar Rimawi, Vandana Abramson, Paula R Pohlmann, Catherine Van Poznak, Andres Forero-Torres, Minetta Liu, Kathryn Ruddy, Yue Zheng, Shoshana M Rosenberg, Richard D Gelber, Lorenzo Trippa, William Barry, Michelle DeMeo, Harold Burstein, Ann Partridge, Eric P Winer, Ian Krop
PURPOSE: The ATEMPT trial was designed to determine if treatment with trastuzumab emtansine (T-DM1) caused less toxicity than paclitaxel plus trastuzumab (TH) and yielded clinically acceptable invasive disease-free survival (iDFS) among patients with stage I human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC). METHODS: Patients with stage I centrally confirmed HER2+ BC were randomly assigned 3:1 to T-DM1 or TH and received T-DM1 3.6 mg/kg IV every 3 weeks for 17 cycles or T 80 mg/m2 IV with H once every week × 12 weeks (4 mg/kg load →2 mg/kg), followed by H × 39 weeks (6 mg/kg once every 3 weeks)...
July 20, 2021: Journal of Clinical Oncology
#37
RANDOMIZED CONTROLLED TRIAL
Anna van der Voort, Mette S van Ramshorst, Erik D van Werkhoven, Ingrid A Mandjes, Inge Kemper, Annelie J Vulink, Irma M Oving, Aafke H Honkoop, Lidwine W Tick, Agnes J van de Wouw, Caroline M Mandigers, Laurence J van Warmerdam, Jelle Wesseling, Marie-Jeanne T Vrancken Peeters, Sabine C Linn, Gabe S Sonke
IMPORTANCE: Primary analysis of the TRAIN-2 study showed high pathologic complete response rates after neoadjuvant chemotherapy with or without anthracyclines plus dual ERBB2 (formerly HER2) blockade. OBJECTIVE: To evaluate 3-year event-free survival (EFS) and overall survival (OS) of an anthracycline-free and anthracycline-containing regimen with dual ERBB2 blockade in patients with stage II and III ERBB2-positive breast cancer. DESIGN, SETTING, AND PARTICIPANTS: A total of 438 patients with stage II and III ERBB2-positive breast cancer were enrolled in this randomized, clinical, open-label phase 3 trial across 37 hospitals in the Netherlands from December 9, 2013, until January 14, 2016...
July 1, 2021: JAMA Oncology
#38
JOURNAL ARTICLE
Rika Kouhashi, Shinichiro Kashiwagi, Yuko Kawano, Akimichi Yabumoto, Sae Ishihara, Wataru Goto, Yuka Asano, Yukie Tauchi, Tamami Morisaki, Satoru Noda, Tsutomu Takashima, Kosei Hirakawa, Masaichi Ohira
Pertuzumab plus trastuzumab plus docetaxel regimen is the first choice for the initial treatment of HER2-positive recurrent breast cancer. However, docetaxel causes many adverse events. A 48-year-old woman was admitted to our hospital for a left breast tumor and was diagnosed with left breast cancer(T1N0M0, Stage Ⅰ, Luminal A). We performed a breast-conserving surgery and sentinel lymph node biopsy, followed by irradiation of the remaining parts of the mammary gland and adjuvant therapy with tamoxifen. Three and a half years after the first surgery, she underwent local resection due to chest wall recurrence of breast cancer...
December 2020: Gan to Kagaku Ryoho. Cancer & Chemotherapy
#39
JOURNAL ARTICLE
Natalia Kunst, Shi-Yi Wang, Annette Hood, Sarah S Mougalian, Michael P DiGiovanna, Kerin Adelson, Lajos Pusztai
Importance: The neoadjuvant treatment options for ERBB2-positive (also known as HER2-positive) breast cancer are associated with different rates of pathologic complete response (pCR). The KATHERINE trial showed that adjuvant trastuzumab emtansine (T-DM1) can reduce recurrence in patients with residual disease compared with patients treated with trastuzumab; however, T-DM1 and other ERBB2-targeted agents are costly, and understanding the costs and health consequences of various combinations of neoadjuvant followed by adjuvant treatments in the United States is needed...
November 2, 2020: JAMA Network Open
#40
JOURNAL ARTICLE
Shogo Nakamoto, Masahiko Ikeda, Shinichiro Kubo, Mari Yamamoto, Tetsumasa Yamashita
BACKGROUND: It is unclear whether the de-escalated therapy that omits anthracycline-based chemotherapy is as beneficial as standard therapy for patients with stage I human epidermal growth factor receptor 2-positive (HER2+ ) early breast cancer. PATIENTS AND METHODS: We retrospectively investigated 95 patients with pathological stage I HER2+ early breast cancer who underwent adjuvant treatment from April 2009 to December 2018. RESULTS: We assessed 45 patients who underwent standard therapy containing anthracyclines, 35 patients who underwent paclitaxel plus trastuzumab (P+TRA group), and 15 patients who underwent trastuzumab monotherapy or no adjuvant therapy; the 5-year invasive disease-free survival rates were 97...
November 2020: In Vivo
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