Therapy For Early Breast Cancer Research Articles

Research Status of Systemic Adjuvant Therapy for Early Breast Cancer.

Breast cancer has surpassed lung cancer as the most common cause of cancer deaths, worldwide. Early breast cancers are treatment sensitive and patients under standardized treatment have prolonged. Breast cancer treatment has significantly evolved from the conventional surgical approach and radiotherapy to local and systemic adjuvant therapies. Though localized breast cancers are clinically manageable, distant recurrence is a cause of morbid concern. Adjuvant systemic therapy is effective in both distant and local recurrences and hence gained significant attention. Early breast cancer prognosis has greatly improved in the past 3 decades with reduced mortality rates due to the widespread use of adjuvant therapy. It can markedly increase the cure rate of breast cancers, and postoperative adjuvant therapy became a part of comprehensive breast cancer treatment. Further research to understand the early breast cancer characteristics could expand the treatment modalities that can improve the outcomes and survival benefits of breast cancer patients.

A Delphi Study of Expert Consensus on Chinese Medicine Syndrome Differentiation and Herbal Use for Early Breast Cancer.

Chinese herbal medicine (CHM) is widely used in breast cancer, but there is no consensus on the Chinese medicine (CM) syndromes in the different conventional treatment stages (preoperative, postoperative, chemotherapy, radiation therapy and endocrine therapy) of early breast cancer. This Delphi study aimed to achieve expert consensus on the CM syndromes, signs and symptoms, and the Chinese herbal formulae for early breast cancer. Thirty senior CM clinicians with expertise in managing breast cancer were enrolled. The syndromes selected by ≥50% of experts and the corresponding most common Chinese herbal formulae were considered a consensus. Consensus on signs and symptoms was defined as a median score ≥4 (the item was important or very important) and ≥70% of experts rating the sign or symptom as 4 (important) or 5 (very important) on a 5-point Likert scale. Three survey rounds were conducted from 15 October 2021 to 10 March 2022. Consensus was reached with 3 syndromes confirmed for each treatment stage. Several syndromes, such as dual deficiency of qi and Blood, were considered common to multiple treatment stages. Some important signs and symptoms were presented in multiple treatment stages (eg, shortage of qi in the radiation therapy and endocrine therapy stages). This Delphi study achieved consensus on the most common CM syndromes, corresponding signs and symptoms, and the most common formulae in each treatment stage of early breast cancer, providing an evidence-based approach for future clinical practice.

Interrupting endocrine therapy in hormone-positive early breast cancer

Interrupting endocrine therapy in hormone-positive early breast cancer

Primary therapy of early breast cancer: Egyptian view of 2021 St. Gallen consensus

PurposeThe theme of the St. Gallen International Breast Cancer Conference 2021 held virtually for the first time, due to the COVID-19 pandemic, was on tailoring therapies for patients with early breast cancer. A monkey survey that included an Egyptian Panel voted on most of the questions of the original St. Gallen consensus, and some added new questions most relevant to oncology practice in the country, to be able to compare voting results that reflect differences in breast cancer management and decision making.MethodsThe panel included 74 Egyptian scientists from different oncology specialties. Management issues including controversial diagnostic and therapeutic interventions were prepared by a small committee and then projected using the online monkey survey website: https://www.surveymonkey.com. The survey included 130 questions. Results were then analyzed, tabulated, and compared to the voting results of the original St. Gallen consensus.Results and conclusionsVoting questions and resulting percentages of answers from the Egyptian panel were summarized. There was no consensus between the Egyptian and the original St. Gallen panels on 28/130 statements. They mostly included genetic and pathologic aspects, specifically the routine use of gene signature assays and a few queries involving surgical, radiotherapeutic, and systemic interventions. Probably, available resources and healthcare system differences in Egypt compared to European and the USA were the cause of these differences. This would also be applicable to other low- and low-middle-income healthcare scenarios present in many countries, especially with the present constraints of the COVID-19 pandemic.

Results of clinical developments of early triple negative breast cancer drug treatment: ASCO - 2022

Introduction. This article continues the series of reviews of innovative clinical developments related to drug therapy for leading cancers following the ASCO-2022 Annual Congress. This time we are seeing the results of therapy for early triple negative breast cancer (hereinafter referred to as TNR) is a consequence of the fact that TNR accounts for 15–20% of cases of all breast cancers, while it is the subtype of breast cancer (hereinafter referred to as BC), for which the choice of treatment methods
 is significantly limited. In Russia, state tasks have been set within the framework of the Federal project “Fight against cancer”,
 which provide for a significant reduction in mortality from neoplasms, including by improving the quality
 and effectiveness of drug treatment.
 Materials and methods. This scientific review is based on the results of a search in the databases of the digital educational platform MEDtalks.nl, PubMed/Medline and Google. Dictionary forms were used in the search strings: "kanker", "vroeg stadium", "triple negatief", "mammacarcinoom", "clinical trials", "ASCO-2022" and others in Dutch and English.
 Results and conclusion. The results presented in this article once again substantiate the prospects for further determination of algorithms for biomarker-personalized immunotherapy (in particular, pembrolizumab) as part of the combined antitumor treatment of RMZHER–/PR–/HER2– at early stages. Radiogenomics/radioproteomics technologies are a prime example of low-cost diagnostic tools that allow promptly suggesting a personalized tumor portrait in the period before biopsy. Further improvement of clinical oncoinformatics technologies (rather large arrays of omics data have already been accumulated) will contribute to a better understanding of programs for individualized choice of differentiated therapy for cancer patients, including patients with RMZHER–/PR–/HER2–.
 For citation: Andreev DA, Zavyalov AA. Results of clinical developments of early triple negative breast cancer drug treatment: ASCO-2022. City Healthсare. 2022;3(4): 122–131 doi: 10.47619/2713-2617.zm.2022.v.3i4;122–131

Does the number of 6-monthly adjuvant zoledronate infusions received affect treatment efficacy for early breast cancer? A sub-study of ABCSG-12

BackgroundThe widespread adoption of adjuvant bisphosphonate therapy for postmenopausal early breast cancer (EBC) patients was based on results of the Early Breast Cancer Trialist Group (EBCTCG) meta-analysis. Despite multiple regimens evaluated, there was no signal of varying efficacy with type, dose/dose intensity of bisphosphonate administration. We evaluated the effect of early treatment cessation using long-term outcome data from the ABCSG-12 trial. Patients and methodsABCSG-12 randomized 1803 hormone-receptor positive EBC patients on ovarian suppression between 1999 and 2006 to receive 4 mg zoledronic acid 6-monthly or not (and tamoxifen or anastrozole, 2:2 factorial design). In the current study, we evaluated whether the number of zoledronate infusions had an impact on breast cancer-specific outcomes. We hypothesized that amongst patients who received at least one zoledronate infusion, the number of infusions had no effect on outcomes. Time-to-event endpoints were analysed with Cox models and Kaplan Meier curves starting from a 3-year landmark. BMD analysis was restricted to patients who participated in the BMD sub-study. Results725 patients who received at least one zoledronate infusion were included in the time-to-event analysis. There was no statistically significant difference in disease-free or overall survival in the patients who received ≤6 zoledronate infusions (n = 170) compared to those who received ≥7 zoledronate infusions (n = 555). ConclusionsComparable to efforts to de-escalate treatment duration in metastatic bone disease, there was no evidence to indicate that a reduced number of zoledronate infusions is associated with reduced adjuvant efficacy. Further studies to define optimal regimens of adjuvant bone-targeted therapies are required.

Optimizing adjuvant and post-neoadjuvant therapy in HER2-positive early breast cancer

Introduction Treatment advances have improved outcomes in human epidermal growth factor receptor 2 (HER2)-positive early-stage breast cancer (eBC) but certain patients remain at high risk of recurrence. Neoadjuvant therapy (NAT) has comparable outcomes to adjuvant therapy with the advantage of surgical down-staging, response assessment, informing prognosis, and tailoring adjuvant treatment. Thus, the standard of care for the majority of HER2-positive eBC has become a combination of chemotherapy and HER2-targeted agents given in the neoadjuvant setting. Areas covered Mounting evidence suggests that pathologic complete response after NAT translates to a favorable long-term prognosis. The efficacy and tolerability of post-NAT are key, particularly for patients with residual disease. This is demonstrated, for example, by the use of trastuzumab emtansine in the appropriate clinical setting and various new drugs under investigation. This review summarizes the current clinical management and exciting future directions to optimize outcomes in HER2-positive eBC. Expert opinion Targeted therapies such as trastuzumab deruxtecan, tucatinib, and immunotherapy have demonstrated impressive responses in metastatic breast cancer, including CNS disease. Incorporating these agents in the post-neoadjuvant space may improve the prognosis of HER2-positive eBC. Future research should prioritize the identification of biomarkers that personalize treatments to achieve maximum benefit and less toxicity.

ERBB2 mutation is associated with sustained tumor cell proliferation after short-term preoperative endocrine therapy in early lobular breast cancer

Invasive lobular breast cancer (ILC) is a special breast cancer (BC) subtype and is mostly hormone receptor (HR)-positive and ERBB2 non-amplified. Endocrine therapy restrains tumor proliferation and is the mainstay of lobular BC treatment. Mutation of ERBB2 has been associated with recurrent ILC. However, it is unknown whether ERBB2 mutation impacts on the otherwise exquisite responsiveness of early ILC to endocrine therapy. We have recently profiled n = 622 HR-positive early BCs from the ADAPT trial for mutations in candidate genes involved in endocrine resistance, including ERBB2. All patients were treated with short-term preoperative endocrine therapy (pET, tamoxifen or aromatase inhibitors) before tumor resection. Tumor proliferation after endocrine therapy (post-pET Ki67 index) was determined prospectively by standardized central pathology assessment supported by computer-assisted image analysis. Sustained or suppressed proliferation were defined as post-pET Ki67 ≥10% or <10%. Here, we report a subgroup analysis pertaining to ILCs in this cohort. ILCs accounted for 179/622 (28.8%) cases. ILCs were enriched in mutations in CDH1 (124/179, 69.3%, P < 0.0001) and ERBB2 (14/179, 7.8%, P < 0.0001), but showed fewer mutations in TP53 (7/179, 3.9%, P = 0.0048) and GATA3 (11/179, 6.1%, P < 0.0001). Considering all BCs irrespective of subtypes, ERBB2 mutation was not associated with proliferation. In ILCs, however, ERBB2 mutations were 3.5-fold more common in cases with sustained post-pET proliferation compared to cases with suppressed post-pET proliferation (10/75, 13.3% versus 4/104, 3.8%, P = 0.0248). Moreover, ERBB2 mutation was associated with high Oncotype DX recurrence scores (P = 0.0087). In summary, our findings support that ERBB2 mutation influences endocrine responsiveness in early lobular BC.

146 (PB-059) Poster - Proton beam therapy for early breast cancer: a systematic review and quantitative synthesis of adverse clinical outcomes

Background: Proton beam therapy (PBT) is increasingly available to some patients with early breast cancer because it achieves better planned dose distributions than standard photon radiotherapy. But there are uncertainties around how planned PBT dose distributions relate to clinical outcomes. This study quantitatively summarises the adverse clinical outcomes of delivered PBT for early breast cancer.

8P Dismantling the role of liquid biopsy in predicting outcome of patients with early-stage breast cancer following neoadjuvant therapy: A systematic review

Numerous studies have suggested that the dynamics of ctDNA during neoadjuvant therapy in early breast cancer have consequences for prognosis. Still, each study's small number of participants prevents drawing firm conclusions. We aimed to determine the predictive value of liquid biopsy in predicting the outcome of patients with early-stage breast cancer following neoadjuvant therapy.

Antibody-drug conjugates targeting Trop-2: Clinical developments in early breast cancer therapy

Although breast cancer has a good prognosis compared with various cancers, metastatic breast cancer has an aggressive disease course and remains incurable. Therefore, treatment of early breast cancer to prevent recurrence and metastasis is crucial. Recently, the development of anti-cancer drugs, such as targeted agents and immuno-oncology, has been accelerating. Antibody-drug conjugates (ADCs) are also building a new paradigm. Particularly, ADCs targeting Trop-2 were approved for their efficacy in metastatic triple-negative breast cancer patients who received ≥2 prior systemic therapies and showed significant results in heavily pretreated hormone receptor-positive/HER2-negative breast cancer. In this brief review, we provide an overview of ongoing clinical trials of ADCs targeting Trop-2 in early breast cancer, specifically sacituzumab govitecan.

Event-Free Survival in Patients with Early HER2-Positive Breast Cancer with a Pathological Complete Response after HER2-Targeted Therapy: A Pooled Analysis.

Simple SummaryThe current standard of care for patients with HER2-positive early breast cancer who have a pathological complete response after neoadjuvant HER2-targeted therapy plus chemotherapy is continuation of HER2-targeted therapy in the adjuvant setting. However, it is not clear how long-term outcomes differ by the HER2-targeted regimen received in each setting. To investigate this question, we pooled patient-level data (n = 1763) from neoadjuvant studies of trastuzumab and pertuzumab to evaluate outcomes with respect to single versus dual HER2 targeting in the neoadjuvant and adjuvant settings. Patients treated with dual HER2-targeted therapy in both the neoadjuvant and adjuvant settings had the highest 4-year event-free survival rates, suggesting that this treatment approach may provide the most benefit for patients with HER2-positive early breast cancer.The standard-of-care for patients with pathological complete response (pCR) after neoadjuvant human epidermal growth factor receptor 2 (HER2)-targeted therapy plus chemotherapy is continuation of HER2-targeted therapy in the adjuvant setting. Our objective was to evaluate risk of recurrence or death in these patients and determine if outcomes differed by the HER2-targeted regimen received in each setting. We analyzed patient-level data from five randomized trials evaluating trastuzumab, pertuzumab, or both as part of systemic neoadjuvant and adjuvant therapy for HER2-positive early breast cancer, and assessed event-free survival (EFS) in 1763 patients. Patients with pCR had decreased risk of an EFS event versus those with residual disease (unadjusted hazard ratio [HR] = 0.35; 95% confidence interval [CI]: 0.27–0.46). Regardless of pCR status, after adjusting for baseline factors, reduction in EFS event risk was greater in patients administered pertuzumab/trastuzumab in both settings versus those administered only trastuzumab in both settings (HR = 0.36; 95% CI: 0.26–0.49), or pertuzumab/trastuzumab in the neoadjuvant setting and only trastuzumab in the adjuvant setting (HR = 0.67; 95% CI: 0.47–0.96). Patients with pCR had longer EFS than those with residual disease. Patients treated with pertuzumab/trastuzumab in both the neoadjuvant and adjuvant settings had the lowest risk of breast cancer recurrence.

Prediction of anthracycline-induced cardiotoxicity as assessed by global longitudinal strain in women with early breast cancer: insights from the PRADA trial

Abstract Background Early recognition of anthracycline-induced cardiotoxicity is essential to prevent and treat left ventricular dysfunction before permanent damage ensues. Echocardiographic global longitudinal strain (GLS) may be a more sensitive indicator of decline in left ventricular systolic function than measurement left ventricular ejection fraction (LVEF). Many factors have been associated with cardiotoxicity defined by LVEF criteria, but less is known about predictors of early and late cardiotoxicity expressed as GLS. Objective The purpose of this study was to identify factors associated with cardiotoxicity, defined as absolute GLS &amp;lt;18% (a) after completion of anthracycline treatment and (b) at extended follow up after completion of adjuvant therapy for early breast cancer. Methods 120 women with early breast cancer undergoing adjuvant treatment with anthracyclines and/or trastuzumab, were included in the PRADA (PRevention of cArdiac Dysfunction during Adjuvant breast cancer) trial and randomized in a 2x2 factorial fashion to concomitant treatment with candesartan cilexetil, metoprolol succinate or matching placebo. Serial measurements of cardiovascular biomarkers (high sensitivity cardiac troponin I (hs-cTnI), B-type natriuretic peptide (BNP) and Galectin-3), cardiovascular magnetic resonance and echocardiography were performed at baseline, after anthracycline treatment and at extended follow-up median 23 months (interquartile range 21–28 months) after initiation of adjuvant therapy for early breast cancer. To identify potential predictors of cardiotoxicity defined by GLS criteria, associations between demographic, clinical, cancer therapy and biochemical and imaging biomarker data were evaluated by logistic regression analysis. Results 89 patients had GLS measurements performed at baseline, 87 at completed anthracycline therapy and 81 at extended follow-up. An overall decline in absolute GLS of 0.75% was observed at extended follow-up. One patient had absolute GLS &amp;lt;18 prior to anthracycline therapy whereas, 7 out of 87 (8.0%) and 7 out of 81 (8.6%) patients had GLS levels &amp;lt;18 after completion of anthracycline treatment and at extended follow up, respectively. Variables associated with absolute GLS &amp;lt;18% after anthracycline treatment and at extended follow-up are summarized in Tables 1a and 1b. Conclusion In this subanalysis of the PRADA trial, higher age, higher hs-cTnI, lower LVEF, lower E' and higher GLS at baseline predicted subsequent reduced systolic function expressed as reduced absolute GLS after anthracycline treatment. Higher age, hypertension, higher body mass index and higher hs-cTnI concentrations predicted absolute GLS &amp;lt;18 at extended follow up. Assessment of cardiac troponin I, cardiac imaging biomarkers and patient age may assist in the identification of patients at risk for developing cardiotoxicity. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): This work was supported by The South-Eastern Norway Regional Health Authority, The University of Oslo, The Extra Foundation for Health and Rehabilitation, The Norwegian Cancer Society, and Akershus University Hospital. Study medications and matching placebos were provided free of charge by AstraZeneca. Reagents for the analysis of high-sensitivity cardiac troponin I on the Architect platform were provided by Abbott Diagnostics.

Immune checkpoint inhibitors as neoadjuvant therapy in early triple-negative breast cancer: A systematic review and meta-analysis.

Immune checkpoint inhibitors combined with chemotherapy are being evaluated in neoadjuvant settings in early triple-negative breast cancer (TNBC). To evaluate efficacy and safety of checkpoint inhibitors in early TNBC. Electronic search was done using PubMed, EMBASE, Google Scholar, Cochrane Central Register of Controlled Trials and clinicaltrials.gov to identify relevant articles till October 31, 2020. Clinical trials evaluating checkpoint inhibitors as neoadjuvant therapy in early-stage TNBC were included. Outcomes assessed included pathologic complete response (pCR), event-free survival (EFS), and safety. Meta-analysis was conducted using Cochrane review manager (RevMan) version 5.4. Randomized controlled trials (RCTs) were assessed for quality using Cochrane Collaboration risk of the bias assessment tool, version 2.0 (ROB-2). GRADE analysis was done to assess the overall quality of evidence for all outcomes. Out of 116 studies screened, 5 RCTs were included in meta-analysis. Compared to control group, programmed death-1 (PD-1)/programmed death-ligand 1 (PDL-1) inhibitor group was associated with significant increase in rate of pCR (odd ratio [OR] =1.71 [1.38-2.11]; P < 0.00001) and EFS (1.77 [1.21-2.60]; P = 0.003). There was a significant increase in risk of serious adverse events (risk ratio [RR] =1.53 [1.28-1.83]; P < 0.00001), adverse events of special interest (AESI) of any grade (RR: 1.5 [1.34-1.69], P < 0.00001) and grade 3 or higher AESI (RR: 2.8 [1.87-4.19], P < 0.00001) with PD-1/PDL-1 inhibitors compared to control. PD-1/PDL-1 inhibitors in combination with neoadjuvant chemotherapy for early TNBC show significant improvement in pCR irrespective of PDL-1 status and cancer stage.

Adjuvant trastuzumab emtansine in HER2-positive breast cancer patients with HER2-negative residual invasive disease in KATHERINE

Following chemotherapy and human epidermal growth factor 2 (HER2)-targeted neoadjuvant therapy for HER2-positive early breast cancer, residual invasive breast cancer at surgery may be HER2-negative on retesting in some patients. We evaluated outcomes with T-DM1 and trastuzumab in patients randomized in the phase III KATHERINE trial based on HER2-positive central testing of the pre-treatment core biopsy with HER2-negative central testing on their corresponding surgical specimen after neoadjuvant treatment. In the 70/845 (8.3%) patients with HER2-negative residual disease on retesting at surgery, there were 11 IDFS events in the 42 trastuzumab-treated patients (26.2%) and none in the 28 T-DM1-treated patients, suggesting that T-DM1 should not be withheld in this patient population.

Experience of the usage intraoperative radiation therapy in patients with early breast cancer

Background. Comprehensive treatment of breast cancer includes surgery, radiation therapy and systemic treatment. Radiation therapy plays an integral role in the treatment of early breast cancer. The appointment of a targeted dose of radiation to the bed of the primary tumor reduces the risk of local recurrence.Objective: to evaluate the effectiveness of intraoperative radiation therapy in the treatment of early breast cancer.Materials and methods. A retrospective study was conducted on the basis of the St. Petersburg City Clinical Oncology Center. Patients with organ-preserving surgery and intraoperative radiation therapy were selected. Of the 352 patients, 273 patients met the inclusion/non-inclusion criteria. Inclusion criteria were verified breast cancer, clinical stage I–IIA, tumor size no more than 3 cm, absence of visible axillary lymph nodes and monocentric nature of tumor growth. All patients underwent sectoral resection of the mammary gland with a biopsy of the sentinel lymph nodes and intraoperative radiation therapy.Results. The mean age of the patients was 59 years. For 273 patients, the median follow-up was 59.1 months. During this period, 18 (6.6 %) local recurrences of the disease were noted, of which 7 (39 %) patients with luminal A, 6 (33 %) patients with luminal B, 1 (6 %) patient with luminal B HER2/neu 3+, and 4 (22 %) patients with triple negative breast cancer. Within 3 years of follow-up, recurrence-free survival was 98.5 %, within 5 years – 96.4 %.Conclusion. The use of intraoperative radiation therapy for early breast cancer is an effective and safe treatment method.

Emerging Targeted Therapies for Early Breast Cancer.

Breast cancer is the most common malignancy and the second leading cause of cancer-related mortality in the United States (US). Most patients are diagnosed with early-stage disease; however, there is still a need to prevent recurrences that often present as incurable metastatic disease. The treatment landscape of early-stage breast cancer is evolving rapidly. The immune checkpoint inhibitor pembrolizumab is approved in combination with neoadjuvant chemotherapy for the treatment of high-risk triple-negative breast cancer (TNBC). The cyclin-dependent kinase (CDK) 4 and 6 inhibitor abemaciclib is approved for adjuvant treatment of patients with high-risk hormone receptor (HR)-positive disease. Whileadjuvant olaparib has shown significant improvement in outcomes for patients with pathogenic/likely pathogenic BRCA1/2 mutations and high-risk human epidermal growth factor receptor 2 (HER2)-negative breast cancer, and is approved in this setting. For the HER2-positive subtype, the post-neoadjuvant therapy can be tailored based on the response to neoadjuvantchemotherapy and HER2-targeted agents. In this narrative review, we summarize the most recent approvals for early-stage breast cancer as well as frequently encountered clinical challenges utilizing these medications.

158P The impact of tumor microenviroment on pathologic complete response after neoadjuvant chemotherapy of early breast cancer

We investigated the impact of baseline tumor infiltrating lymphocytes (TIL) density and TIL composition along with clinicopathological factors on pathologic complete response (pCR) rate in patients treated with standard neoadjuvant chemotherapy ± targeted therapy for early breast cancer.

163P Development and validation of the prognostic HER2RI assay for predicting recurrence and survival in early HER2-positive breast cancer

HER2-positive accounts for 15-20% of breast cancers. Today the decision to escalate or de-escalate systemic therapy for early HER2-positive breast cancer is based primarily on traditional clinical factors, which are insufficient to reflect the molecular complexity and heterogeneity of HER2-positive breast cancer. Here we describe the development and validation of a new HER2RI assay, a model that combines expression data of 16 genes and clinical features to obtain risk values to predict the prognosis of early HER2-positive breast cancer.

Cardiac safety analysis of anti-HER2-targeted therapy in early breast cancer

To evaluate the cardiac safety of anti-HER2-targeted therapy for early breast cancer; to investigate whether trastuzumab combined with pertuzumab increases cardiac toxicity compared with trastuzumab; to evaluate the predictive value of high-sensitivity Troponin (hs-TnI) and QTc for the cardiotoxicity associated with anti-HER2 targeted therapy in early breast cancer. A total of 420 patients with early-stage HER2-positive breast cancer who received trastuzumab or trastuzumab combined with pertuzumab for more than half a year in Tianjin Medical University Cancer Hospital from January 2018 to February 2021 were included. Left ventricle ejection fraction (LVEF), hs-TnI values, and QTc were measured at baseline and 3, 6, 9, 12 months. Cardiotoxicity was defined as a decrease in LVEF of at least 10 percentage points from baseline on follow-up echocardiography. Cardiotoxicity developed in 67 of the 420 patients (15.9%) and all patients had LVEF above 50% before and after treatment. The incidence of cardiotoxicity in trastuzumab and trastuzumab combined with pertuzumab was 14.3% and 17.9%, respectively (P > 0.05). Logistic regression analysis showed that age, coronary heart disease, left chest wall radiotherapy, and anthracyclines sequential therapy were independent risk factors for cardiotoxicity (P < 0.05). The value of hs-TnI and QTc at the end of treatment (12th month) were selected for ROC curve prediction analysis and the area under the ROC curve was 0.724 and 0.713, respectively, which was significantly different from the area of 0.5 (P < 0.05). The decrease of LVEF in the study was mostly asymptomatic, from the heart safety point of view, the anti-HER2 targeted therapy for early breast cancer was well tolerated. Trastuzumab combined with pertuzumab did not significantly increase cardiotoxicity. However, subgroup analysis suggests that in the presence of coronary artery disease (CAD) and sequential treatment with anthracene, trastuzumab and pertuzumab may increase the cardiac burden compared with trastuzumab. Hs-TnI and QTc may be useful in monitoring and predicting cardiotoxicity associated with anti-HER2 targeted therapy for early breast cancer.