A real-world study of cardiac events in > 3700 patients with HER2-positive early breast cancer treated with trastuzumab: final analysis of the OHERA study.


PURPOSE:Cardiac dysfunction risk associated with intravenous trastuzumab (H IV) treatment may differ in real-world practice versus randomized trials. We investigated cardiac events in patients with HER2-positive early breast cancer (EBC) treated with H IV as adjuvant therapy in routine practice. METHODS:The observational study of cardiac events in patients with HER2-positive EBC treated with Herceptin (OHERA; NCT01152606) enrolled patients with stage I-IIIb disease eligible for H IV in the adjuvant setting per the European Summary of Product Characteristics (SmPC). Primary outcomes were symptomatic congestive heart failure incidence (CHF; New York Heart Association class II-IV) and cardiac death. Patient visits/assessments were per local practice. RESULTS:3733 Patients received ≥ 1 H IV dose per local practice; 88.9% received H IV for > 300 days (median follow-up: ~ 5 years). Prior to disease recurrence (if any), symptomatic CHF occurred in 106 patients (2.8%); 6 (0.2%) cardiac deaths occurred (5 in patients with cardiac disease history). Median time to symptomatic CHF onset was 5.7 months (95% CI 5.3-6.5); 77/106 (72.6%) patients with symptomatic CHF achieved resolution. CHF incidence was higher in patients ≥ 65 years, and those with pre-existing cardiac conditions, hypertension, or left ventricular ejection fraction ≤ 55% at baseline. CONCLUSIONS:OHERA is the largest prospective observational study to investigate the cardiac safety of H IV as adjuvant EBC therapy in a real-world setting. Symptomatic CHF and cardiac event incidences were consistent with randomized trials in this setting and baseline risk factors identified in the H IV European SmPC.


Lidbrink E,Chmielowska E,Otremba B,Bouhlel A,Lauer S,Liste Hermoso M,Nüesch E,Shing M,Misra V




Has Abstract


2019-02-01 00:00:00














  • Factors predicting in-breast tumor recurrence after breast-conserving surgery.

    abstract:PURPOSE:The main objectives of this study were to identify risk factors for local in-breast tumor recurrence after breast-conservation and to evaluate the impact of IBTR (in-breast tumor recurrence) on overall survival. METHODS:A total of 335 consecutive patients with 346 invasive and in situ breast cancers were treat...

    journal_title:Breast cancer research and treatment

    pub_type: 临床试验,杂志文章


    authors: Mechera R,Viehl CT,Oertli D

    更新日期:2009-07-01 00:00:00

  • Antibodies to 46-kDa retinal antigen in a patient with breast carcinoma and cancer-associated retinopathy.

    abstract::Cancer-associated retinopathy (CAR) is a rare paraneoplastic syndrome usually associated with small-cell lung carcinoma and serum autoantibodies against recovering. We report the breast cancer woman with visual impairments and electrophysiological abnormalities characteristic of CAR. Her serum contained high-titer ant...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章


    authors: Ejma M,Misiuk-Hojło M,Gorczyca WA,Podemski R,Szymaniec S,Kuropatwa M,Rogozińska-Szczepka J,Bartnik W

    更新日期:2008-07-01 00:00:00

  • Effectiveness of an additional individualized multi-component complementary medicine treatment on health-related quality of life in breast cancer patients: a pragmatic randomized trial.

    abstract::The aim of this study was to evaluate the effectiveness of an additional, individualized, multi-component complementary medicine treatment offered to breast cancer patients at the Merano Hospital (South Tyrol) on health-related quality of life compared to patients receiving usual care only. A randomized pragmatic tria...

    journal_title:Breast cancer research and treatment

    pub_type: 临床试验,杂志文章,随机对照试验


    authors: Witt CM,Außerer O,Baier S,Heidegger H,Icke K,Mayr O,Mitterer M,Roll S,Spizzo G,Scherer A,Thuile C,Wieser A,Schützler L

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  • Pharmacokinetic and pharmacodynamic analysis of fulvestrant in preclinical models of breast cancer to assess the importance of its estrogen receptor-α degrader activity in antitumor efficacy.

    abstract:PURPOSE:Fulvestrant is a selective estrogen receptor downregulator (SERD) that is approved for first- or second-line use as a single agent or in combination with cyclin dependent kinase or phosphatidylinositol 3-kinase inhibitors for the treatment of metastatic breast cancer. Fulvestrant exhibits exceptionally effectiv...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章


    authors: Wardell SE,Yllanes AP,Chao CA,Bae Y,Andreano KJ,Desautels TK,Heetderks KA,Blitzer JT,Norris JD,McDonnell DP

    更新日期:2020-01-01 00:00:00

  • Kinetic and morphometric responses of heterogeneous populations of NMU-induced rat mammary tumor cells to hormone and antipolyamine therapy in vivo.

    abstract::The present experiments were designed to evaluate in vivo the differential sensitivity of tumor cell subpopulations to hormone and polyamine manipulations using the hormone-responsive N-nitrosomethyl-urea (NMU)-induced rat mammary tumor. NMU tumor bearing rats were randomly assigned to control, ovariectomy, alpha-difl...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章


    authors: Manni A,Lancaster S,English H,Badger B,Lynch J,Demers L

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  • A randomized, double-blind, phase 2 study of ruxolitinib or placebo in combination with capecitabine in patients with advanced HER2-negative breast cancer and elevated C-reactive protein, a marker of systemic inflammation.

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    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章,随机对照试验


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  • Cellular localisation by in situ hybridisation of cathepsin D, stromelysin 3, and urokinase plasminogen activator RNAs in breast cancer.

    abstract::We have compared by RNA in situ hybridisation on serial cryo-sections the distribution of cathepsin D (cathD), stromelysin 3 (strom-3), and urokinase plasminogen activator (UPA) gene expression in different tissues of human benign and malignant mammary tumors. Cath-D expression was found to be higher in adenocarcinoma...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章


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    更新日期:1996-01-01 00:00:00

  • The effect of age and density of the breast on the sensitivity of breast cancer diagnostic by mammography and ultasonography.

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    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章


    authors: Saarenmaa I,Salminen T,Geiger U,Heikkinen P,Hyvärinen S,Isola J,Kataja V,Kokko ML,Kokko R,Kumpulainen E,Kärkkäinen A,Pakkanen J,Peltonen P,Piironen A,Salo A,Talviala ML,Haka M

    更新日期:2001-05-01 00:00:00

  • Postoperative complications and survival of elderly breast cancer patients: a FOCUS study analysis.

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    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章


    authors: de Glas NA,Kiderlen M,Bastiaannet E,de Craen AJ,van de Water W,van de Velde CJ,Liefers GJ

    更新日期:2013-04-01 00:00:00

  • Activation of raf-1, MEK, and MAP kinase in prolactin responsive mammary cells.

    abstract::The polypeptide hormone prolactin (Prl), acting through its cell surface receptors, promotes growth and differentiation in normal and malignant breast cells. We demonstrate herein that two Prl-responsive cell lines, NOG-8 normal mouse mammary epithelial and T47D human breast cancer cells, respond to Prl by rapid and t...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章


    authors: Das R,Vonderhaar BK

    更新日期:1996-01-01 00:00:00

  • Intratumor genomic heterogeneity in breast cancer with clonal divergence between primary carcinomas and lymph node metastases.

    abstract::Conflicting theories of epithelial carcinogenesis disagree on the clonal composition of primary tumors and on the time at which metastases occur. In order to study the spatial distribution of disparate clonal populations within breast carcinomas and the extent of the genetic relationship between primary tumors and reg...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章


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    更新日期:2007-04-01 00:00:00

  • Genotypes and phenotypes of IGF-I and IGFBP-3 in breast tumors among Chinese women.

    abstract::The relationship between IGF genotypes and phenotypes in breast tumors and their associations with breast cancer risk remain to be elucidated. Such information is especially scarce in Chinese women. To evaluate IGF-I and IGFBP-3 genotypes in relation to their phenotypes in local breast tissues and in association with ...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章


    authors: Qian B,Zheng H,Yu H,Chen K

    更新日期:2011-11-01 00:00:00

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    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章


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    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章,评审


    authors: Offodile AC 2nd,Sheckter CC,Tucker A,Watzker A,Ottino K,Zammert M,Padula WV

    更新日期:2017-10-01 00:00:00

  • Pertuzumab, trastuzumab, and docetaxel for Chinese patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer (PUFFIN): a phase III, randomized, double-blind, placebo-controlled study.

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    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章


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    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章


    authors: Reeder-Hayes KE,Bainbridge J,Meyer AM,Amos KD,Weiner BJ,Godley PA,Carpenter WR

    更新日期:2011-08-01 00:00:00

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    abstract::The pharmacokinetics of free and different liposomal formulations of hexadecylphosphocholine (HPC) was investigated in tumor-bearing (human mammary tumor MaTu) and tumor-free mice after intravenous and intraperitoneal administration. The levels of HPC were evaluated at different times in serum, normal tissues, and tum...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章


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    更新日期:1999-11-01 00:00:00

  • Axillary lymph node status of operable breast cancers by combined steroid receptor and HER-2 status: triple positive tumours are more likely lymph node positive.

    abstract:AIMS:To examine the frequency of axillary lymph node (ALN) invasion of operable breast cancers by their combined oestrogen receptor (ER), progesterone receptor (PR) and HER-2 status. METHODS:2227 recently operated cases in one centre were retrieved from the Multidisciplinary Breast Centre database and stratified accor...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章


    authors: Van Calster B,Vanden Bempt I,Drijkoningen M,Pochet N,Cheng J,Van Huffel S,Hendrickx W,Decock J,Huang HJ,Leunen K,Amant F,Berteloot P,Paridaens R,Wildiers H,Van Limbergen E,Weltens C,Timmerman D,Van Gorp T,Smeets A,V

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    abstract::It has long been hypothesized that personality is associated with breast cancer risk and survival. The present population-based prospective cohort study in Japan tested this hypothesis. To investigate the association of personality with breast cancer risk, a total of 15,107 women aged 40-64 years who completed the Eys...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章


    authors: Minami Y,Hosokawa T,Nakaya N,Sugawara Y,Nishino Y,Kakugawa Y,Fukao A,Tsuji I

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    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章


    authors: Vogsen M,Jensen JD,Christensen IY,Gerke O,Jylling AMB,Larsen LB,Braad PE,Søe KL,Bille C,Ewertz M,Hildebrandt MG

    更新日期:2021-01-01 00:00:00

  • Assessment of different criteria for the pathological complete response (pCR) to primary chemotherapy in breast cancer: standardization is needed.

    abstract:PURPOSE:Evaluation of the safety and efficacy of a combination of docetaxel and doxorubicin in breast cancer patients. Evaluation and comparison of the pathological complete response (pCR) to this regimen according to various definitions in different clinical trials. Utilize the data to propose standardization of defin...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章


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    更新日期:2009-01-01 00:00:00

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    abstract:PURPOSE:Elevated expression of PAI-1 has been widely linked with adverse outcomes in a variety of human cancers, such as breast, gastric and ovarian cancers, rendering PAI-1 a prognostic biomarker. As a result, several chemical inhibitors are currently being developed against PAI-1; however, the clinical setting where ...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章


    authors: Tzekaki EE,Geromichalos G,Lavrentiadou SN,Tsantarliotou MP,Pantazaki AA,Papaspyropoulos A

    更新日期:2021-01-03 00:00:00

  • Proliferative activity of breast cancers increases in the course of genetic evolution as defined by cytogenetic analysis.

    abstract::The prognostic value of proliferative activity and its relationship with steroid hormone receptors and histopathological grade have been demonstrated for breast cancers. However, nothing is known about the underlying mechanisms. In order to understand the chronology of the appearance of increased proliferative activit...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章


    authors: Remvikos Y,Gerbault-Seureau M,Magdelénat H,Prieur M,Dutrillaux B

    更新日期:1992-01-01 00:00:00

  • Association between thyroid gland diseases and breast cancer: a case-control study.

    abstract:BACKGROUND:At the present time, there is no consensus on the association between benign thyroid diseases and breast cancer (BC). Therefore, the aim of this study is to help shed some light on the association between hyperthyroidism, hypothyroidism, and thyroiditis and breast cancer risk. METHODS:Use of the Disease Ana...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章


    authors: Bach L,Kostev K,Schiffmann L,Kalder M

    更新日期:2020-07-01 00:00:00

  • Inhibition of growth and appearance of estrogen-dependent rat mammary tumors by 10-propargylestr-4-ene-3,17-dione, an aromatase inhibitor.

    abstract::The aromatase inhibitor 10-propargylestr-4-ene-3,17-dione (PED) has been evaluated in vivo as an anticancer agent. Prolonged administration of PED to rats bearing dimethylbenzanthracene-induced mammary tumors resulted in significant regression of hormone-responsive tumors within several days. Greater than 50% regressi...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章


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    更新日期:1993-01-01 00:00:00

  • Utility of ankyrin 3 as a prognostic marker in androgen-receptor-positive breast cancer.

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    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章


    authors: Kurozumi S,Joseph C,Raafat S,Sonbul S,Kariri Y,Alsaeed S,Pigera M,Alsaleem M,Nolan CC,Johnston SJ,Aleskandarany MA,Ogden A,Fujii T,Shirabe K,Martin SG,Alshankyty I,Mongan NP,Ellis IO,Green AR,Rakha EA

    更新日期:2019-07-01 00:00:00

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    abstract::The clinicopathologic, mammographic, and sonographic findings in patients with pure ductal carcinoma in situ (DCIS) were assessed by estrogen receptor (ER) expression. After institutional review board approval, patients with pure DCIS evaluated from January 1996 to July 2009 with known ER status and available imaging ...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章


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    更新日期:2013-06-01 00:00:00

  • Oestrogen receptor-mediated modulation of the EGFR/MAPK pathway in tamoxifen-resistant MCF-7 cells.

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    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章


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    更新日期:2003-09-01 00:00:00

  • Ethanol promotes mammary tumor growth and angiogenesis: the involvement of chemoattractant factor MCP-1.

    abstract::Alcohol consumption is a risk factor for breast cancer in humans. Experimental studies indicate that alcohol exposure promotes malignant progression of mammary tumors. However, the underlying cellular and molecular mechanisms remain unclear. Alcohol induces a pro-inflammatory response by modulating the expression of c...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章


    authors: Wang S,Xu M,Li F,Wang X,Bower KA,Frank JA,Lu Y,Chen G,Zhang Z,Ke Z,Shi X,Luo J

    更新日期:2012-06-01 00:00:00

  • Recurrence outcomes after omission of postoperative radiotherapy following breast-conserving surgery for ductal carcinoma in situ of the breast: a multicenter, retrospective study in Korea (KROG 16-02).

    abstract:PURPOSE:To evaluate the loco-regional recurrence (LRR) rate after breast-conserving surgery without postoperative radiotherapy (RT) for ductal carcinoma in situ (DCIS) of the breast. METHODS:Between 2000 and 2010, 311 DCIS patients from 9 institutions were analyzed retrospectively. The median age was 47 (range, 20-82)...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章,多中心研究


    authors: Kim K,Jung SY,Shin KH,Kim JH,Han W,Lee HB,Huh SJ,Choi DH,Park W,Ahn SD,Kim SS,Kim JH,Suh CO,Kim YB,Kim IA,Kim S,Kim YJ

    更新日期:2017-02-01 00:00:00