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Open Access Study Protocol Issue
Rationale and Trial Design of DAWNA‐FES Trial: Single‐Arm Phase Ⅱ Study of Endocrine Therapy With Dalpiciclib After Progression on CDK4/6 Inhibition Based on [18F]FES PET/CT in Patients With HR+/HER2− Advanced Breast Cancer
Cancer Innovation 2026, 5(3): e70058
Published: 30 April 2026
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Background

Cyclin‐dependent kinase 4/6 (CDK4/6) inhibitors have become a cornerstone in the first‐line management of hormone receptor‐positive, human epidermal growth factor receptor 2‐negative (HR+/HER2−) advanced breast cancer. Despite their clinical efficacy, most patients eventually experience disease progression, and optimal treatment strategies following CDK4/6 inhibitor resistance remain unclear. Emerging evidence suggests that switching endocrine therapy (ET) while continuing cyclin inhibition may provide additional clinical benefit. Dalpiciclib, a selective CDK4/6 inhibitor, in combination with physician‐selected ET, represents a potential option in this setting. Concurrently, 16α‐[18F]fluoro‐17β‐estradiol ([18F]FES) PET/CT, a novel imaging modality targeting estrogen receptors (ER), enables non‐invasive, whole‐body assessment of ER expression in metastatic lesions, offering a personalized approach to treatment selection.

Methods

This is a prospective, single‐center, single‐arm Phase Ⅱ clinical trial evaluating the efficacy and safety of dalpiciclib plus ET in HR+/HER2− advanced breast cancer patients who progressed on prior CDK4/6 inhibitor therapy. Forty eligible patients with confirmed metastases and at least one [18F]FES‐positive lesion will be enrolled. Participants will receive dalpiciclib combined with ET as determined by the treating physician. The primary endpoint is progression‐free survival (PFS). Secondary endpoints include objective response rate (ORR), disease control rate (DCR), and overall survival (OS).

Discussion

Beyond evaluating efficacy, this single‐center phase Ⅱ trial will provide practical insight into the feasibility of [18F]FES PET/CT‐guided patient selection, including standardized imaging workflows and multidisciplinary implementation in routine clinical research. Positive outcomes may support a personalized, imaging‐guided strategy to prolong disease control after prior CDK4/6 inhibitor progression.

Ethical Approval and Trial Registration

Approved by the Ethics Committee of Peking Union Medical College Hospital (Approval number: K3629); registered at ClinicalTrials. gov (NCT05613270).

Review Issue
Application of 21-gene Recurrence Score in Hormone Receptor Positive Breast Cancer Patients
Medical Journal of Peking Union Medical College Hospital 2023, 14(6): 1274-1281
Published: 30 November 2023
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In the past decade, with the introduction of precision medicine, the treatment of breast cancer has entered a new era. It now tends towards the de-escalation and individualization of treatment plans, aiming to minimize iatrogenic toxicity while maximizing benefits for patients without compromising survival outcomes. The 21-gene assay evaluates the expression levels of 21 genes associated with breast cancer recurrence and provides a 21-gene recurrence score (RS) to assess the risk of recurrence and potential benefit from chemotherapy in breast cancer patients. Currently, RS is recommended by multiple guidelines such as the American Society of Clinical Oncology (ASCO), National Comprehensive Cancer Network (NCCN), and Chinese Anti-Cancer Association(CACA) for guiding adjuvant therapy in hormone receptor-positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) early-stage breast cancer patients. However, there are still controversies surrounding its clinical application. Current research mainly focuses on optimizing RS to accurately identify patients who would benefit from adjuvant therapy, thus enabling more personalized treatment plans for breast cancer patients. This review provides an overview of the 21-gene assay, its application in HR+ breast cancer patients' adjuvant therapy, its impact on clinical decision-making, existing controversies regarding RS, and prospects for integrating RS with clinical pathological information. The aim is to guide further expansion of RS's application in clinical practice and achieve more precise adjuvant therapy for breast cancer patients.

Open Access Original Article Issue
Binary and Ternary Classification Prediction for Breast Cancer and Breast Sclerosing Adenosis With Interpretable Artificial Intelligence From Clinical and Imaging Features: A Retrospective, Diagnostic Accuracy Cohort Study
Cancer Innovation 2026, 5(1): e70049
Published: 05 March 2026
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Background

Sclerosing adenosis (SA) and breast cancer (BC) often exhibit overlapping clinical, imaging, and pathological characteristics, making them difficult to differentiate. SA may also coexist with BC (SA + BC), including ductal carcinoma in situ (SA‐DCIS) and invasive breast cancer (SA‐IBC), which complicates diagnosis even when core‐needle biopsy (CNB) suggests SA. This study aimed to develop interpretable AI‐based binary and ternary classification models that leverage clinical and imaging features to distinguish SA‐only from SA + BC and to further differentiate among SA‐only, SA‐DCIS, and SA‐IBC.

Methods

We retrospectively analyzed a cohort of 726 patients with SA (January 2006 to December 2021), comprising 537 SA‐only and 189 SA + BC cases (90 SA‐DCIS, 99 SA‐IBC). Multiple machine learning algorithms—logistic regression, support vector machine, decision tree, XGBoost, and random forest—were compared using AUC, accuracy, F1‐score, and C‐index. Model interpretability was assessed with SHAP to elucidate feature contributions and identify key predictors. Additionally, we incorporated an independent external validation cohort consisting of 113 patients to verify the model's effectiveness.

Results

XGBoost consistently outperformed other algorithms in both tasks. Eight features emerged as most informative: age, ultrasound BI‐RADS category, maximum and minimum ultrasound diameters, ultrasound margin characteristics, biopsy procedure, mammographic density, and microcalcifications. For binary classification (SA‐only vs. SA + BC), XGBoost achieved an AUC of 0.925, accuracy of 0.883, and C‐index of 0.844. For ternary classification (SA‐only, SA‐DCIS, SA‐IBC), the model achieved an AUC of 0.888, accuracy of 0.811, and C‐index of 0.813. Age, ultrasound BI‐RADS, and minimum lesion diameter were consistently top predictors. We further proposed a three‐tier interpretability framework (global, cohort‐level; local, subgroup‐level; and individual, case‐level) to facilitate clinical translation.

Conclusion

Given the substantial risk of coexisting of SA with DCIS or IBC, and the potential for CNB to underestimate disease due to limited sampling, lesions diagnosed as SA on CNB should be evaluated with additional modalities before determining the need for surgical excision. The proposed interpretable AI model enhances discrimination between SA‐only and SA with concomitant breast cancer (SA + BC), thereby supporting more informed clinical decision‐making in breast disease management.

Issue
Evaluation of the Efficacy of Local Corticosteroid Injection in the Treatment of Idiopathic Granulomatous Mastitis: A Retrospective Cohort Study Based on Clinical Cases
Medical Journal of Peking Union Medical College Hospital 2025, 16(5): 1214-1220
Published: 22 August 2025
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Objective

To compare the clinical efficacy of intralesional corticosteroid injection combined with topical corticosteroids versus topical corticosteroids alone in patients with idiopathic granulomatous mastitis (IGM).

Methods

Patients diagnosed with IGM and treated at the Breast Surgery Department of Peking Union Medical College Hospital between October 2016 and March 2018 were retrospectively analyzed. Based on treatment modalities, patients were divided into an injection group (receiving intralesional corticosteroid injections plus topical corticosteroids) and a control group (receiving topical corticosteroids alone). Clinical outcomes and recurrence rates were compared between the two groups.

Results

Seventy-eight patients meeting the inclusion and exclusion criteria were enrolled, with 51 in the injection group and 27 in the control group. The median age was 35 years (range: 22-45). The maximum lesion diameter was 8.7±2.9 cm in the injection group and 7.1±2.7 cm in the control group. Compared with the control group, the injection group showed a significantly shorter time to half remission(2.8±0.9 weeks vs. 4.2±1.3 weeks, P < 0.001) and a shorter time to complete remission(8.8±2.5 weeks vs. 10.1±2.7 weeks, P=0.043). During a follow-up period of 74 months, recurrence occurred in 2 patients in the injection group (1 ipsilateral and 1 contralateral) and 1 patient in the control group (contralateral).

Conclusions

Compared with topical corticosteroid monotherapy, the combina-tion of intralesional corticosteroid injection and topical corticosteroids provides faster symptom control and shorter treatment duration while maintaining high efficacy and low long-term recurrence rates, offering a more effective therapeutic option for IGM patients.

Issue
Novel 18F-FES PET/CT in Non-invasive Functional Diagnosis of Delayed Lung Metastasis Presented with Horner Syndrome in a Metastatic Breast Cancer Patient
Medical Journal of Peking Union Medical College Hospital 2024, 15(3): 702-707
Published: 30 May 2024
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Hormonal receptor positive human epidermal receptor 2 negative (HR+/HER2-) is the commonest molecular subtype of breast cancer (BC). Patients with HR+/HER2- BC may manifest clinically a late recurrence whose BC metastasizes 10-15 years post-operatively. We report one case who presented with pulmonary mass in upper lobe of lung and Horner syndrome 16 years after BC surgery. FDG PET/CT suggested pulmonary malignancy but could not differentiate between primary or metastatic cancer when invasive biopsy was quite risky. Novel 18F-FES PET/CT facilitated the non-invasive functional diagnosis of estrogen-receptor positive (ER+) pulmonary metastasis of BC, and the patient experienced partial response (PR) after CDK4/6 inhibitor and aromatase inhibitor as endocrine therapy. This article reviews the diagnosis and treatment process of this case, to provide guidance for non-invasive global evaluation of ER status among metastatic HR+/HER2- BC patients with 18F-FES PET/CT.

Issue
PTEN Mutation Related Unilateral Multicentric, Synchronous and Metachronous Bilateral Breast Cancer: Three Case Reports
Medical Journal of Peking Union Medical College Hospital 2024, 15(4): 916-920
Published: 30 July 2024
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Phosphatase and tensin-homolog deleted on chromosome 10 (PTEN) is an important cancer suppressor gene. Its pathogenic mutation leads to PTEN hamartoma tumor syndrome (PHTS), a rare syndrome also known as Cowden syndrome, which is relevant to early-onset hereditary breast cancer (BC). In this paper, we report three patients with unilateral multicentric BC and synchronous and metachronous bilateral BC who harbored PTEN gene mutations, and summarize the clinical manifestations, pathological characteristics, diagnosis, treatment and follow-up outcomes to provide reference for management of PTEN gene mutation-related BC among the Cowden syndrome population.

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