^
    1d
    Use of OncotypeDx in women with ER+/HER2- breast cancer after surgery: the experience of Ancona Breast Unit (AIOM 2024)
    According to literature, and TailorX trial data, our study confirms the importance of ODX as a tool able to guide therapeutic choices and ensure patients the most appropriate adjuvant treatment.
    Clinical • Surgery
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • PGR expression
    |
    Oncotype DX Breast Recurrence Score®Test
    1d
    Elacestrant plus alpelisib in an ESR1 and PIK3CA co-mutated and heavily pretreated metastatic breast cancer: the first case report for combination efficacy and safety. (PubMed, Ther Adv Med Oncol)
    We achieved a remarkable response in the metastatic lesions with minor toxicity issues. This case highlights the importance of utilizing up-to-date therapeutic agents and reactive decision-making during personalized cancer treatment.
    Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HR positive • HER-2 negative • PIK3CA mutation • ER mutation • ESR1 mutation • CDK4 mutation
    |
    Piqray (alpelisib) • Orserdu (elacestrant)
    1d
    Stromal tumor infiltrating lymphocytes in hormone receptor positive/HER2 negative metastatic breast cancer. (PubMed, Mod Pathol)
    Finally, sTIL levels were significantly higher in lung and axillary lymph node metastases compared to all metastases. While these analyses were conducted on multiple metastases obtained at the end of life after several lines of treatment, the data provides novel and valuable insights into the state of immune infiltration in patients with metastatic HR+/HER2- BC.
    Journal • Tumor-infiltrating lymphocyte • Stroma • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 positive • HR positive • HER-2 negative • ER negative • HR positive + HER-2 negative • PTEN mutation + HR positive • HER-2 negative + ER positive
    1d
    High CTLA-4 gene expression is an independent good prognosis factor in breast cancer patients, especially in the HER2-enriched subtype. (PubMed, Cancer Cell Int)
    Considering all these data, we can conclude that the expression of immunoregulatory genes depends on tumor phenotype and has potential clinical implications in BC patients.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • JAK2 (Janus kinase 2) • PD-1 (Programmed cell death 1) • CD276 (CD276 Molecule) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • PD-L2 (Programmed Cell Death 1 Ligand 2)
    |
    HER-2 positive • HER-2 negative • PD-1 expression • CTLA4 expression • PD-L2 expression
    2d
    The journey of patients affected by metastatic hormone receptor-positive/HER2-negative breast cancer from CDK 4/6 inhibitors to second-line treatment: A real-world analysis of 701 patients enrolled in the GIM14/BIOMETA study. (PubMed, Eur J Cancer)
    Endocrine therapy plus CDK 4/6i represents an effective treatment, regardless of HER2 status (low/zero). Second-line agents did not differ significantly in terms of TTD. Endocrine resistant cancers exhibit poor response to CDK 4/6i.
    Journal • Real-world evidence • Real-world • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative • PTEN mutation + HR positive
    |
    everolimus • capecitabine • fulvestrant • exemestane
    2d
    Normal tissue transcriptional signatures for tumor-type-agnostic phenotype prediction. (PubMed, Sci Rep)
    Broadly, our findings suggest that cancer often arrogates normal tissue transcriptomic characteristics as a component of both malignant progression and drug response. This quantitative framework provides a strategy for connecting the diversity of cancer phenotypes and could potentially help manage individual patients.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    2d
    Utidelone combined with anti‑angiogenic therapy for the treatment of anthracycline/taxane‑treated and endocrine‑resistant HR+/HER2‑ refractory breast cancer with brain metastases: A case report. (PubMed, Oncol Lett)
    This result was superior to the second-line treatment with nab-paclitaxel, which resulted in a PFS of 8 months and best overall response of stable disease with slight shrinkage. The present case indicates that a combination of utidelone with apatinib/anlotinib exhibited antitumor activity in a patient with HR+/HER2- mBC with BMs. Therefore, this combination offers a promising therapeutic option for the clinical treatment of patients with breast cancer and BMs.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    Focus V (anlotinib) • AiTan (rivoceranib) • albumin-bound paclitaxel • utidelone IV (UTD1)
    3d
    Overall survival after CDK4/6 inhibitor dose reduction in women with metastatic breast cancer. (PubMed, BJC Rep)
    Dose reduction of CDK4/6 inhibitors within the first 12 weeks of treatment was associated with significantly higher mortality and shorter treatment duration. These findings contrast with previous analyses showing no effect of dose reduction, likely due to considering immortal time bias in this study.
    Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative • PTEN mutation + HR positive
    |
    fulvestrant
    3d
    Real-world effectiveness of CDK 4/6 inhibitors in estrogen-positive metastatic breast cancer. (PubMed, BJC Rep)
    This study confirms first-line CDK 4/6i effectiveness, with abemaciclib and ribociclib showing prolonged PFS vs. palbociclib. This study could not confirm a ranking of the three CDK 4/6i.
    Journal • Real-world evidence • Real-world effectiveness • Real-world • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 positive • ER positive • HER-2 negative • ER positive + HER-2 negative • HER-2 negative + ER positive
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib)
    3d
    Testing the Addition of an Anti-cancer Drug, Berzosertib, to the Usual Treatment (Radiation Therapy) for Chemotherapy-Resistant Triple-Negative and Estrogen and/or Progesterone Receptor Positive, HER2 Negative Breast Cancer (clinicaltrials.gov)
    P1, N=42, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    berzosertib (M6620)
    3d
    ROMANCE: Radiotherapy Omission in Low Risk Ductal in Situ Carcinoma Breast (clinicaltrials.gov)
    P=N/A, N=300, Active, not recruiting, UNICANCER | Recruiting --> Active, not recruiting
    Enrollment closed • Surgery
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    3d
    Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+/HER2- Breast Cancer (NEOTORCH-BREAST01) (clinicaltrials.gov)
    P2, N=30, Recruiting, First Affiliated Hospital of Zhejiang University | N=50 --> 30 | Trial completion date: Oct 2029 --> Jun 2029 | Initiation date: Oct 2024 --> Jun 2024 | Trial primary completion date: Oct 2026 --> Jun 2026
    Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    paclitaxel • Loqtorzi (toripalimab-tpzi) • cyclophosphamide • epirubicin
    3d
    Real-world outcomes of everolimus-based treatment in a Taiwanese cohort with metastatic HR+/HER2- breast cancer. (PubMed, J Chin Med Assoc)
    These findings support current guidelines and advocate for the inclusion of everolimus in treatment plans for patients with metastatic HR+/HER2- breast cancer, particularly in late-line treatment, with careful consideration of the benefit-risk profile for each patient.
    Journal • Real-world evidence • Real-world • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    everolimus
    3d
    Prognostic significance and identification of m6A regulator genes and hub genes associated with m6A in breast cancer. (PubMed, Discov Oncol)
    Clinical sample analyses revealed notably elevated expression levels of ZNF260 in hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR + /HER2-) BC tissues compared to adjacent non-tumor tissues (all P < 0.001). Reduction in ZNF260 expression was shown to inhibit the proliferation, clonogenicity, migration, and invasiveness of MCF-7 cells while concomitantly enhancing apoptosis (all P < 0.001).This investigation uniquely uncovered ZNF260 as a novel key gene, suggesting its potential utility as a predictive biomarker associated with m6A modifications specifically in HR + /HER2- BC.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • EGFR positive
    3d
    Pilot Study of Neoadjuvant Chemotherapy Combined With Immunotherapy and Multimodal Thermal Therapy for HER2-negative Breast Cancer (clinicaltrials.gov)
    P=N/A, N=14, Recruiting, Fudan University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    carboplatin • AiRuiKa (camrelizumab) • albumin-bound paclitaxel • goserelin acetate
    3d
    Immunologic Targeting of ESR1 Receptor for Hormone Receptor Expressing Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=18, Not yet recruiting, H. Lee Moffitt Cancer Center and Research Institute
    New P1 trial • Metastases
    |
    Orserdu (elacestrant)
    3d
    Using bioinformatics and artificial intelligence to map the cyclin-dependent kinase 4/6 inhibitor biomarker landscape in breast cancer. (PubMed, Future Oncol)
    To identify biomarkers associated with CDK4/6 inhibitor response or resistance, we combined bioinformatic-database analyses, artificial intelligence-assisted literature review, and manual literature review (Embase and OVID Medline; search window: January 2012-October 2022) to compile data to comprehensively describe the CDK4/6 inhibitor biomarker landscape. Based on these results, and validation by external experts, we identified 15 biomarkers of clinical importance (AR , AURKA, ERBB2, ESR1, CCNE1, CDKN1A/B, CDK2, CDK6, CDK7, CDK9, FGFR1/2, MYC, PIK3CA/AKT, RB1 and STAT3) that could guide future breast cancer research.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • FGFR1 (Fibroblast growth factor receptor 1) • RB1 (RB Transcriptional Corepressor 1) • CCNE1 (Cyclin E1) • STAT3 (Signal Transducer And Activator Of Transcription 3) • AURKA (Aurora kinase A) • CDK2 (Cyclin-dependent kinase 2) • CDK7 (Cyclin Dependent Kinase 7) • CDK9 (Cyclin Dependent Kinase 9) • CDKN1A (Cyclin-dependent kinase inhibitor 1A)
    |
    HR positive • HER-2 negative • EGFR positive
    3d
    MAP3K1 mutations confer tumor immune heterogeneity in hormone receptor-positive HER2-negative breast cancer. (PubMed, J Clin Invest)
    In preclinical models, the postbiotics tyramine could reverse the MAP3K1 mutation-induced MHC-I reduction, thereby augmenting the efficacy of immunotherapy. Collectively, our study identified the vital biomarker driving the immunological heterogeneity of HR+/HER2- breast cancer and elucidated the underlying molecular mechanisms, which provided the promise of tyramine as a novel therapeutic strategy to enhance the efficacy of immunotherapy.
    Journal • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • CD8 (cluster of differentiation 8) • MAP3K1 (Mitogen-Activated Protein Kinase Kinase Kinase 1) • TAP1 (Transporter 1)
    |
    HER-2 positive • HR positive • HER-2 negative • HER-2 mutation • HR positive + HER-2 negative • MAP3K1 mutation • PTEN mutation + HR positive
    3d
    Phase Ib clinical and pharmacodynamic study of the TIE2 kinase inhibitor rebastinib with paclitaxel or eribulin in HER2-negative metastatic breast cancer. (PubMed, Clin Cancer Res)
    In patients with MBC, the recommended phase 2 dose of rebastinib associated with pharmacodynamic evidence of TIE2 inhibition is either 50 or 100 mg PO BID in combination with paclitaxel or eribulin.
    P1 data • PK/PD data • Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    paclitaxel • Halaven (eribulin mesylate) • rebastinib (DCC-2036)
    4d
    Low-dose apatinib in combination with chemotherapy for hormone receptor-positive, HER2-negative breast cancer with pulmonary lymphangitic carcinomatosis: A case report. (PubMed, Medicine (Baltimore))
    This case highlights the potential antitumor activity of apatinib in breast cancer patients with presenting with PLC. While further studies are necessary, this therapeutic approach could represent a viable option for managing breast cancer in the context of a visceral crisis. The case also emphasizes the importance of individualized treatment strategies and further research to substantiate these promising findings.
    Journal • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative • PTEN mutation + HR positive
    |
    AiTan (rivoceranib) • capecitabine • albumin-bound paclitaxel
    4d
    Financial Difficulty Over Time in Young Adults With Breast Cancer. (PubMed, JAMA Netw Open)
    In this cohort study of young adults with breast cancer, we identified a subset of patients who experienced a high degree of financial difficulty persisting into early survivorship. Targeted interventions to mitigate financial toxicity-modifiable factors that include support for the employability or return to work support for those experiencing arm symptoms after treatment-are needed.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • ER positive + PGR positive • PGR positive
    4d
    EPIK-B6: Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=24, Active, not recruiting, Novartis Pharmaceuticals | Trial primary completion date: Jan 2025 --> Jul 2025
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HER-2 negative • PIK3CA mutation
    |
    Piqray (alpelisib) • fulvestrant
    4d
    Fulvestrant, Palbociclib and Erdafitinib in ER+/HER2-/FGFR-amplified Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=35, Completed, Vanderbilt-Ingram Cancer Center | Active, not recruiting --> Completed | Trial completion date: Sep 2024 --> Mar 2024
    Trial completion • Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • FGFR2 (Fibroblast growth factor receptor 2) • FGFR1 (Fibroblast growth factor receptor 1) • FGFR4 (Fibroblast growth factor receptor 4) • FGF23 (Fibroblast Growth Factor 23)
    |
    HER-2 negative • FGFR1 amplification • FGFR3 amplification • FGFR4 amplification • FGFR amplification
    |
    Ibrance (palbociclib) • Balversa (erdafitinib) • fulvestrant
    4d
    Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=69, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Feb 2025 --> Aug 2025
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HER-2 negative • PIK3CA mutation
    |
    Piqray (alpelisib) • fulvestrant
    4d
    FIH Study of RGT-419B Alone and With Endocrine Therapy in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=64, Recruiting, Regor Pharmaceuticals Inc. | N=18 --> 64
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • CDK4 (Cyclin-dependent kinase 4)
    |
    HER-2 negative • PIK3CA mutation
    |
    RGT-419B
    5d
    A Study Assessing Risk Factors for Oral Mucositis/Stomatitis and Ocular Surface Events in NSCLC and Breast Cancer (clinicaltrials.gov)
    P=N/A, N=13759, Recruiting, Daiichi Sankyo
    New trial
    5d
    Frequency of FDA-Approved Companion Diagnostic Biomarkers in Solid Tumors (AMP 2024)
    Genomic profiling yields clinically actionable information for approved therapies and evidence of resistance, and it may uncover rational therapeutic opportunities regardless of tumor type.
    Tumor mutational burden • Companion diagnostic • BRCA Biomarker • MSi-H Biomarker • BRCA Companion diagnostic • MSi-H Companion diagnostic
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ER (Estrogen receptor) • ALK (Anaplastic lymphoma kinase) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability) • RET (Ret Proto-Oncogene) • PTEN (Phosphatase and tensin homolog) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • AKT1 (V-akt murine thymoma viral oncogene homolog 1)
    |
    BRAF V600E • KRAS mutation • BRCA2 mutation • TMB-H • MSI-H/dMMR • KRAS G12C • HER-2 negative • PIK3CA mutation • BRAF V600 • NTRK1 fusion • NTRK3 fusion • NTRK2 fusion • RET fusion • ROS1 fusion • KRAS G12 • KRAS exon 2 mutation • ALK-ROS1 fusion
    |
    OncoExTra™ test
    5d
    Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49) (clinicaltrials.gov)
    P3, N=340, Active, not recruiting, Merck Sharp & Dohme LLC | N=800 --> 340 | Trial completion date: Jul 2028 --> Mar 2025 | Trial primary completion date: Jul 2028 --> Mar 2025
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    Keytruda (pembrolizumab) • paclitaxel • capecitabine • albumin-bound paclitaxel • pegylated liposomal doxorubicin
    5d
    SGNB7H4V-001: A Study of SGN-B7H4V in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=572, Recruiting, Seagen Inc. | N=430 --> 572 | Trial completion date: Jan 2027 --> Nov 2027 | Trial primary completion date: Jun 2025 --> Nov 2027
    Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • PTEN mutation + HR positive
    |
    Keytruda (pembrolizumab) • felmetatug vedotin (PF-08046048)
    5d
    NeoAdj. Therapy Comparing Sacituzumab Govitecan (SG) vs. SG+Pembrolizumab in Low-risk, Triple-neg. EBC (ADAPT-TN-III) (clinicaltrials.gov)
    P2, N=348, Recruiting, West German Study Group | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 negative • PGR negative
    |
    Keytruda (pembrolizumab) • Trodelvy (sacituzumab govitecan-hziy)
    6d
    ADAPTcycle: Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC (clinicaltrials.gov)
    P3, N=1684, Active, not recruiting, West German Study Group | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive • HER-2 negative + PGR positive
    |
    Kisqali (ribociclib)
    8d
    A single-arm, single-center clinical study of chidamide in combination with vinorelbine and capecitabine in the treatment of HER2-negative advanced breast cancer (ChiCTR2400090102)
    P2, N=26, Not yet recruiting, ChongQing university cancer hospital; ChongQing university cancer hospital
    New P2 trial • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    capecitabine • vinorelbine tartrate • Epidaza (chidamide)
    8d
    Neoadjuvant endocrine therapy for breast cancer (ChiCTR2400088944)
    P2, N=60, Recruiting, The First Affiliated Hospital of Xi'an Jiaotong University; The First Affiliated Hospital of Xi'an Jiaotong University
    New P2 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HR positive • HER-2 negative • HER-2 expression • PGR positive • PTEN mutation + HR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive • HER-2 negative + PGR positive
    8d
    A Multicenter, Open-label, Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of YL202 in Subjects With Locally Advanced or Metastatic Breast Cancer Who Are TNBC and HR Positive, HER2 Zero, or HER2 Hypoactive (ChiCTR2400089158)
    P2, N=180, Recruiting, Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center
    New P2 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HR positive • HER-2 negative • HER-2 expression • HER-2 underexpression • PGR expression • HER-2 negative + HR negative
    |
    BNT326
    8d
    Dalcilib combined with aromatase inhibitors and capecitabine neoadjuvant therapy Open, single arm, multi arm treatment of HR positive/HER2 negative early breast cancer Central research (ChiCTR2400090076)
    P2, N=30, Not yet recruiting, Fujian Medical University Affiliated Union Hospital; Fujian Medical University Affiliated Union Hospital
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • HER-2 expression • PGR expression
    |
    capecitabine
    8d
    A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BGB-C354, an Antibody-Drug Conjugate Targeting B7H3, Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors (ChiCTR2400091198)
    P1, N=92, Not yet recruiting, Jilin Cancer Hospital; Jilin Cancer Hospital
    New P1 trial • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CD276 (CD276 Molecule) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    EGFR mutation • HER-2 negative • EGFR wild-type • CD276 expression
    |
    Tevimbra (tislelizumab-jsgr)
    10d
    Study to Evaluate Biomarkers and Safety of Dapagliflozin Concomitant With Neoadjuvant Therapy (clinicaltrials.gov)
    P1, N=20, Recruiting, Yale University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Farxiga (dapagliflozin)
    10d
    Paxalisib Plus Olaparib or Pembrolizumab/Chemotherapy in Advanced Breast Cancer (ACTRN12624001340527)
    P1, N=24, Not yet recruiting, Kazia Therapeutics
    New P1 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    HER-2 negative
    |
    Keytruda (pembrolizumab) • Lynparza (olaparib) • carboplatin • albumin-bound paclitaxel • paxalisib (GDC-0084)
    10d
    NeoTOP: Neoadjuvant Phase II Trial in Patients With T1c Operable, HER2-positive Breast Cancer According to TOP2A Status (clinicaltrials.gov)
    P2, N=86, Completed, UNICANCER | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 positive • HER-2 negative • HER-2 negative + HR negative • HER-2 positive + HR negative
    |
    Herceptin (trastuzumab) • carboplatin • docetaxel • Perjeta (pertuzumab) • cyclophosphamide • epirubicin
    10d
    IPATunity150: A Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=20, Terminated, Hoffmann-La Roche | Phase classification: P3 --> P1
    Phase classification • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • fulvestrant • ipatasertib (RG7440)
    10d
    TRIFOUR: Nadunolimab in Combination with Gemcitabine Plus Carboplatin in Patients with Advanced Triple Negative Breast Cancer. (clinicaltrials.gov)
    P1/2, N=116, Recruiting, Cantargia AB | Trial primary completion date: Aug 2026 --> Jun 2025
    Trial primary completion date • Combination therapy • BRCA Companion diagnostic • PARP Companion diagnostic • Metastases
    |
    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)
    |
    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)
    10d
    ICARUS-BREAST01: Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=99, Active, not recruiting, Gustave Roussy, Cancer Campus, Grand Paris | Recruiting --> Active, not recruiting | N=170 --> 99 | Trial completion date: Jun 2026 --> Apr 2028 | Trial primary completion date: Jan 2024 --> Apr 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    patritumab deruxtecan (U3-1402)