^
    2d
    IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=540, Not yet recruiting, Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
    New P3 trial
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HR positive
    |
    Herceptin (trastuzumab) • paclitaxel • docetaxel • Perjeta (pertuzumab) • IBI-354
    2d
    FACT-TN: FMD and Neoadjuvant Chemo-immunotherapy in TNBC (clinicaltrials.gov)
    P2, N=80, Not yet recruiting, Sun Yat-sen University
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • HER-2 negative + ER positive • HER-2 negative + HR negative
    |
    docetaxel • Loqtorzi (toripalimab-tpzi) • doxorubicin hydrochloride • albumin-bound paclitaxel • cyclophosphamide • epirubicin
    3d
    Comparison of survival outcomes between neoadjuvant and adjuvant therapy in patients with T1c, lymph node-negative, and hormone receptor-negative breast cancer: a study based on the SEER database and a Chinese cohort (ChiCTR2500115125)
    P=N/A, N=400, Not yet recruiting, West China Hospital of Sichuan University; West China Hospital of Sichuan University
    New trial
    3d
    Efficacy and Safety of Iparomlimab and Tuvonralimab Combined with Albumin-bound Paclitaxel and Lobaplatin as Neoadjuvant Therapy for Stage II-III Triple-negative Breast Cancer：A Prospective, Multicenter, Single-Arm Study (ChiCTR2500114072)
    P4, N=67, Not yet recruiting, The First Affiliated Hospital of Army Medical University; The First Affiliated Hospital of Army Medical University
    New P4 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 amplification • HER-2 negative • ER negative
    |
    albumin-bound paclitaxel • lobaplatin (D19466) • Qibeian (iparomlimab/tuvonralimab) • iparomlimab (QL1604)
    3d
    A Phase II, Single-Arm Clinical Study of Goserelin Microspheres for Ovarian Function Preservation During Adjuvant Chemotherapy in Premenopausal Patients with Early Breast Cancer (ChiCTR2500113196)
    P2, N=25, Not yet recruiting, The Third Bethune Hospital of Jilin University; The Third Bethune Hospital of Jilin University
    New P2 trial
    |
    ER (Estrogen receptor)
    |
    ER negative
    |
    goserelin acetate
    3d
    A single-arm, multicenter, phase II clinical trial on sacituzumab tirumotecan with toripalimab in neoadjuvant therapy for triple-negative breast cancer (ChiCTR2600116626)
    P2, N=34, Not yet recruiting, Jiangxi Cancer Hospital; Jiangxi Cancer Hospital
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER negative
    |
    Loqtorzi (toripalimab-tpzi) • Jiataile (sacituzumab tirumotecan)
    3d
    Cadonilimab combined with gemcitabine plus carboplatin in metastatic triple-negative breast cancer: a single-arm, multicenter, phase II clinical study (ChiCTR2600117338)
    P2, N=38, Recruiting, Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • ER negative
    |
    carboplatin • gemcitabine • Kaitanni (cadonilimab)
    3d
    A Phase I Dose-Escalation and Dose-Expansion Clinical Study Evaluating the Tolerability, Safety, Pharmacokinetics , and Efficacy of MT027 Cell Injection in Patients with Triple-Negative Breast Cancer and Brain Metastases (ChiCTR2600116792)
    P1, N=22, Not yet recruiting, Guangdong Provincial People's Hospital; Guangdong Provincial People's Hospital
    New P1 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD276 (CD276 Molecule)
    |
    ER negative
    |
    MT027
    3d
    Preoperative Oral Dihydroartemisinin Triple-Negative Breast Cancer: A Single-Center, Open-Label, Single-Arm Pilot Study (ChiCTR2500102437)
    P=N/A, N=8, Recruiting, Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center | Not yet recruiting --> Recruiting | Initiation date: May 2025 --> Oct 2025
    Enrollment open • Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • ER negative
    6d
    Vaccine Therapy and Pembrolizumab in Treating Patients With Solid Tumors That Have Failed Prior Therapy (clinicaltrials.gov)
    P1, N=11, Active, not recruiting, City of Hope Medical Center | Trial completion date: Oct 2025 --> Oct 2026
    Trial completion date
    |
    TP53 (Tumor protein P53) • MSI (Microsatellite instability)
    |
    TP53 mutation
    |
    Keytruda (pembrolizumab) • p53MVA
    6d
    Testing the Role of FDG-PET/CT to Predict Response to Therapy Prior to Surgery for HER2-positive Breast Cancer, The DIRECT Trial (clinicaltrials.gov)
    P2, N=235, Active, not recruiting, ECOG-ACRIN Cancer Research Group | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive • HR positive • HER-2 negative
    13d
    Case Report: Pathological complete response yet early brain relapse in HER2-positive breast cancer: a case-based review. (PubMed, Front Immunol)
    We report a 60-year-old woman with HER2-positive, hormone receptor-negative breast cancer who achieved pCR after neoadjuvant docetaxel combined with trastuzumab and pertuzumab, followed by 12 months of maintenance trastuzumab and pertuzumab. Emerging CNS-active therapies, including small-molecule tyrosine kinase inhibitors (TKIs) such as tucatinib and next-generation antibody-drug conjugates (ADCs) like trastuzumab deruxtecan, have shown promising intracranial activity. In addition, advanced strategies such as intensified MRI surveillance, radiomics, liquid biopsy, focused ultrasound-mediated BBB disruption, nanoparticle delivery systems, and radionuclide therapy offer potential avenues for early identification and prevention of cerebral metastases.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR negative
    |
    docetaxel • Perjeta (pertuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Tukysa (tucatinib)