^
    1d
    EVOLVE-BDT: Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies (clinicaltrials.gov)
    P2, N=700, Recruiting, UNC Lineberger Comprehensive Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    everolimus • capecitabine • Verzenio (abemaciclib)
    2d
    Clinical presentations and prognostication of HER2-low and HER2-zero early breast cancer in Taiwan. (PubMed, J Chin Med Assoc)
    In Taiwanese early stage breast cancer, HER2-low is common and associated with greater HR positivity and modestly inferior OS/RFS relative to HER2 zero after HR and stage stratification. These clinicopathological distinctions may influence future eligibility for the novel targeted therapy at metastatic relapse, even when early stage outcome differences are small. Further studies are warranted to understand the biological and therapeutic relevance of this newly established taxonomy.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive • HER-2 negative • HER-2 negative + HR negative
    7d
    A Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer (clinicaltrials.gov)
    P1/2, N=100, Recruiting, Pfizer
    Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • BRCA (Breast cancer early onset)
    |
    HER-2 expression • BRCA mutation • PD-L1 expression + HER-2 overexpression
    |
    Aidixi (disitamab vedotin)
    8d
    TRIFOUR: Nadunolimab in Combination With Gemcitabine Plus Carboplatin in Patients With Advanced Triple Negative Breast Cancer. (clinicaltrials.gov)
    P1/2, N=117, Active, not recruiting, Cantargia AB | Trial primary completion date: Jun 2025 --> Apr 2026
    Trial primary completion date • BRCA Companion diagnostic • PARP Companion diagnostic
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset) • CD4 (CD4 Molecule)
    |
    BRCA2 mutation • BRCA1 mutation • HER-2 negative • HER-2 negative + HR negative • HER-2 negative + HR negative + BRCA mutation
    |
    PD-L1 IHC 22C3 pharmDx • Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    carboplatin • gemcitabine • nadunolimab (CAN04)
    11d
    Omega 3 Fatty Acids and ERPR(-)HER2(+/-) Breast Cancer Prevention (clinicaltrials.gov)
    P=N/A, N=80, Active, not recruiting, City of Hope Medical Center | Trial completion date: Jun 2026 --> Feb 2027 | Trial primary completion date: Jun 2026 --> Feb 2027
    Trial completion date • Trial primary completion date
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER negative
    11d
    QLC5513 Alone or in Combination With QL1706 in Previously Treated Advanced or Metastatic TNBC. (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Fudan University
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • ER negative
    |
    Qibeian (iparomlimab/tuvonralimab)
    12d
    FUSCC Refractory TNBC Platform Study (FUTURE2.0) (clinicaltrials.gov)
    P2, N=120, Recruiting, Fudan University
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • ER negative
    |
    everolimus • AiRuiKa (camrelizumab) • trastuzumab rezetecan (SHR-A1811) • famitinib (SHR 1020)
    14d
    Endogenous and environmental factors that induce DNA replication defects and genomic instability in ER-negative heterozygous BRCA1 cells. (PubMed, Sci Rep)
    Approximately 70% of BRCA1-associated breast cancers are triple negative (TNBC; progesterone (PR), HER2, estrogen receptor (ER)-negative), which were reported to develop from ER/PR-negative luminal progenitor cells...In summary, these results reveal that alterations in estrogen metabolism caused by environmental or endogenous factors are genotoxic for ER-negative BRCA1mut/+ mammary cells. And our results also show that the dietary compound I3C can prevent estrogen-induced DNA damage, and suggest that I3C can be a potential cancer-preventive therapeutic agent for BRCA1 carriers.
    Journal • BRCA Biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • BRCA1 (Breast cancer 1, early onset)
    |
    BRCA1 mutation • ER negative
    15d
    Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Locally Advanced or Inflammatory Triple Negative Breast Cancer (clinicaltrials.gov)
    P2, N=67, Active, not recruiting, City of Hope Medical Center | Trial completion date: Dec 2025 --> Nov 2026
    Trial completion date
    |
    MammaPrint®
    |
    carboplatin • albumin-bound paclitaxel
    16d
    Add-Aspirin: A Trial Assessing the Effects of Aspirin on Disease Recurrence and Survival After Primary Therapy in Common Non Metastatic Solid Tumours (clinicaltrials.gov)
    P3, N=11000, Active, not recruiting, University College, London | Not yet recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 positive • ER positive • HR positive • HER-2 negative • HR negative • ER negative • HER-2 negative + ER positive • HER-2 negative + HR negative
    |
    aspirin
    16d
    GIM25-CAPT: A Phase II trial of atezolizumab plus CArboplatin plus nab-Paclitaxel as first-line Therapy in metastatic triple-negative PD-L1 positive breast cancer patients (2024-519514-31-00)
    P1/2, N=104, Recruiting, Consorzio Oncotech | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • HER-2 negative • HR negative • HER-2 negative + HR negative
    |
    VENTANA PD-L1 (SP142) Assay
    |
    Tecentriq (atezolizumab) • carboplatin • albumin-bound paclitaxel
    18d
    BRIA-ABC: Combination Study of SV-BR-1-GM With Retifanlimab (clinicaltrials.gov)
    P1/2, N=36, Completed, BriaCell Therapeutics Corporation | Enrolling by invitation --> Completed | Trial completion date: Nov 2028 --> Mar 2026 | Trial primary completion date: Nov 2025 --> Mar 2026
    Trial completion • Trial completion date • Trial primary completion date
    |
    ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor)
    |
    HER-2 positive • HER-2 negative • PGR positive
    |
    cyclophosphamide • Zynyz (retifanlimab-dlwr) • Bria-IMT (SV-BR-1-GM)