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    BIOMARKER:

    PTEN mutation + HR positive

    i
    Other names: PTEN, Phosphatase and tensin homolog, Mutated In Multiple Advanced Cancers 1, Phosphatase And Tensin Homolog, Phosphatidylinositol 3,4,5-Trisphosphate 3-Phosphatase And Dual-Specificity Protein Phosphatase PTEN, MMAC1, TEP1, MMAC1 Phosphatase And Tensin Homolog Deleted On Chromosome 10, Mitochondrial Phosphatase And Tensin Protein Alpha, Phosphatase And Tensin-Like Protein, Protein Tyrosine Phosphatase, Mitochondrial PTENalpha, PTENbeta, PTEN1, CWS1, GLM2, MHAM, PGR, Progesterone receptor, Nuclear receptor subfamily 3 group C member 3, NR3C3, ESR1, Era, ESR, NR3A1, ER, ER beta
    Entrez ID:
    2099; 5241; 5728
    Related biomarkers:
    Expression
    Mutation
    CNA
    Fusion
    Others
    2d
    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
    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
    9d
    The Role of the NOLUS Score in Predicting pCR and iDFS in HR-positive HER2-negative Early Breast Cancer Patients who Received Neoadjuvant Chemotherapy. (PubMed, Cancer Diagn Progn)
    NOLUS positivity was observed in 20.43% of patients aged 22-50, compared to 8.93% in those over 50, though this difference was not statistically significant. NOLUS exhibits potential in predicting pCR in HR+/HER2- breast cancer, serving as a cost-effective substitute for genomic tests.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative • PTEN mutation + HR positive
    9d
    REALNESS: Observational Study on the Treatment of Patients With Metastatic Breast Cancer (clinicaltrials.gov)
    P=N/A, N=200, Not yet recruiting, AstraZeneca
    New trial • Real-world evidence • Real-world • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 negative • HR positive + HER-2 negative • PTEN mutation + HR positive
    11d
    Comparative efficacy & safety of buparlisib plus fulvestrant, fulvestrant plus dalpiciclib, and ribociclib plus letrozole for postmenopausal, hormone receptor-positive, and HER2-negative breast cancer. (PubMed, Clinics (Sao Paulo))
    Dalpiciclib plus fulvestrant is effective and comparatively safe in postmenopausal women with hormone receptor-positive and HER2-negative breast cancers. Dalpiciclib, buparlisib, fulvestrant, and ribociclib cause neutropenia, severe depression, adverse gastroenterological effects, and adverse hepatological effects, respectively.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative • PTEN mutation + HR positive
    |
    Kisqali (ribociclib) • fulvestrant • letrozole • buparlisib (AN2025) • AiRuiKang (dalpiciclib)
    11d
    TIFA: Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=15, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Oct 2024 --> Oct 2025 | Trial primary completion date: Oct 2024 --> Oct 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HR positive • HER-2 negative • PIK3CA mutation • PTEN mutation + HR positive • HER-2 negative + HR positive + PIK3CA mutation
    |
    Piqray (alpelisib) • fulvestrant
    13d
    Clinical and financial impact of implementation of Oncotype Dx in women with HR positive HER2 negative early breast cancer treated in a Chilean Cancer Center. (SABCS 2024)
    No abstract available
    Clinical
    |
    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
    |
    Oncotype DX Breast Recurrence Score®Test
    15d
    Patient with hormone receptor‑positive Her2‑negative metastatic breast cancer with visceral crisis with good response to abemaciclib and letrozole: A case report and review of the literature. (PubMed, Mol Clin Oncol)
    Furthermore, the side effects were manageable and no dose reductions were necessary during treatment. These findings suggest that the combination of CDK4/6i and ET in the treatment of HR+/HER2-advanced breast cancer cannot be underestimated.
    Review • 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
    |
    Verzenio (abemaciclib) • letrozole
    15d
    Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer. (PubMed, N Engl J Med)
    In patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer, inavolisib plus palbociclib-fulvestrant led to significantly longer progression-free survival than placebo plus palbociclib-fulvestrant, with a greater incidence of toxic effects. The percentage of patients who discontinued any trial agent because of adverse events was low. (Funded by F. Hoffmann-La Roche; INAVO120 ClinicalTrials.gov number, NCT04191499.).
    Clinical • Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HR positive • HER-2 negative • PIK3CA mutation • PIK3CA mutation + HR positive • EGFR positive • HR positive + HER-2 negative • PTEN mutation + HR positive • HER-2 negative + HR positive + PIK3CA mutation
    |
    Ibrance (palbociclib) • fulvestrant • Itovebi (inavolisib)
    15d
    Can Ki-67 serve as a suitable marker to indicate the necessity of staging diagnostics in cases of low-risk breast cancer? (PubMed, Arch Gynecol Obstet)
    Distant metastases are rare in low-risk EBC. All in all, staging diagnostics should not be routinely employed in this patient population. Only patients with high Ki-67 developed distant metastases. In these cases, staging diagnostics may be discussed with the patient.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative • PTEN mutation + HR positive
    16d
    BTCRC-BRE19-409: Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=44, Recruiting, Marina N Sharifi | Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Sep 2024 --> Sep 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HER-2 amplification • HER-2 negative • PIK3CA mutation • HR positive + HER-2 negative • PTEN mutation + HR positive • HER-2 negative + HR positive + PIK3CA mutation
    |
    Piqray (alpelisib) • fulvestrant
    18d
    Prognosis prediction with the IHC3 score in patients with node-negative, hormone receptor-positive, HER2-negative early breast cancer. (PubMed, ESMO Open)
    IHC3 is able to define prognostic groups in patients with node-negative, HRpos/HER2neg eBC. Node-negative patients with a high IHC3 score had the worst prognosis, which was comparable to that of node-positive patients described in recent trials. This simple and cost-effective tool could thus potentially aid in identifying patient groups for innovative therapeutic approaches.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative • PTEN mutation + HR positive
    18d
    Screening of BindingDB database ligands against EGFR, HER2, Estrogen, Progesterone and NF-κB receptors based on machine learning and molecular docking. (PubMed, Comput Biol Med)
    The binding energy range for these ligands against their respective targets was calculated to be between -15 and -5 kcal/mol. Finally, based on general and common rules in medicinal chemistry, we selected 2, 3, 3, and 8 new ligands with high priority for further studies in the EGFR+HER2, ER, NF-κB, and PR classes, respectively.
    Journal • Machine learning
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive • HER-2 negative • HR negative • HR positive + HER-2 negative • HR positive + HER-2 positive • PTEN mutation + HR positive • HER-2 negative + HR negative • HER-2 positive + HR negative • HR negative + HER-2 positive
    19d
    Evaluating CDK4/6 Inhibitor Therapy in Elderly Patients with Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer: A Retrospective Real-World Multicenter Study. (PubMed, Cancers (Basel))
    CDK4/6 inhibitors with endocrine therapy are effective in elderly patients with metastatic HR+/HER2- breast cancer, though careful management is crucial to balance efficacy and minimize adverse events.
    Clinical • Retrospective data • Journal • Real-world evidence • Real-world • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative • PTEN mutation + HR positive
    21d
    Monitoring the Response of Cyclin-Dependent Kinase 4/6 Inhibitors with Mean Corpuscular Volume. (PubMed, Curr Oncol)
    This study highlights that patients with MCV delta > 10 had longer median progression-free survival compared to those with MCV delta ≤ 10.
    Retrospective data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative • PTEN mutation + HR positive
    |
    Ibrance (palbociclib) • Kisqali (ribociclib)
    21d
    Comparison of Risk Stratification by CanAssist Breast Test Performed on Core Needle Biopsies Versus Surgical Specimens in Hormone Receptor-Positive, Her2-Negative Early Breast Cancer. (PubMed, Cureus)
    Additionally, in a real-world scenario, it is more likely that CAB will be performed on CNB first. Conclusion CAB when performed on CNB samples showed high concordance with SS thus demonstrating that CNB was a suitable sample for the CanAssist Breast test. The accuracy in the low-risk category is 97.5%, which ensures that physicians can reliably use prognostic information by testing CNB to guide adjuvant therapy decisions.
    Journal • Biopsy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative • PTEN mutation + HR positive
    21d
    Higher risk of recurrence in early-stage breast cancer patients with increased levels of ribosomal protein S6. (PubMed, Sci Rep)
    When assessed in combination with lymph node status, the predictive capacity was higher compared to both univariate models individually. In conclusion, pS6 could represent a novel independent marker for predicting recurrence risk in luminal breast cancer.
    Observational data • Retrospective data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • RPS6 (Ribosomal Protein S6)
    |
    HER-2 positive • HR positive • HER-2 negative • PIK3CA mutation • AKT1 mutation • HR positive + HER-2 negative • PTEN mutation + HR positive • HER-2 negative + HR positive + AKT1 mutation
    24d
    Implementing geriatric assessment for dose optimization of CDK4/6 inhibitors in older breast cancer patients. (PubMed, Future Oncol)
    However, a higher risk for adverse events due to CDK4/6 inhibitors among older patients is evident, leading to a trend of initiating CDK4/6 inhibitors at lower dose in clinical practice, though without evidence. The aim of the IMPORTANT-trial, a pragmatic, multinational, open-label, partly decentralized randomized trial is to investigate whether lower starting dose of CDK4/6 inhibitors combined with endocrine therapy is comparable to full dose in older (≥70 years old) patients with advanced HR+/HER2- breast cancer who are assessed as vulnerable or frail based on comprehensive geriatric assessment.Clinical Trial Registration: NCT06044623 (ClinicalTrials.gov); Registration date: 13 September 2023.
    Journal
    |
    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
    25d
    MORPHEUS: A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer (clinicaltrials.gov)
    P1/2, N=138, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative • PTEN mutation + HR positive
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • tamoxifen • Verzenio (abemaciclib) • fulvestrant • ipatasertib (RG7440) • exemestane • Jingzhuda (entinostat)
    26d
    Disparities in receipt of 1-st line CDK4/6 inhibitors with endocrine therapy for treatment of hormone receptor positive, HER2 negative metastatic breast cancer in the real-world setting. (PubMed, Breast Cancer Res)
    In this real-world database, disparities in receiving 1st -line CDK4/6 inhibitors were seen by age, diagnosis stage, baseline performance status, comorbidity, and insurance status. In adjusted analysis, the use of 1st -line CDK4/6i plus ET yielded better PFS and OS rates than ET alone. Further efforts are essential to enhance equitable use of and access to this crucial drug class.
    Observational data • Journal • Real-world evidence • Real-world • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative • PTEN mutation + HR positive
    1m
    Chemotherapy in older patients with early breast cancer. (PubMed, Breast)
    The aim of our narrative review is to provide a concise overview of the evidence on chemotherapy in older women with breast cancer and place it in the context of geriatric assessment and risk evaluation in older HR-positive, HER2-negative patients with early breast cancer. This in turn should help to critically weigh up the risks and benefits of chemotherapy for the individual older patient with early-stage breast cancer, which should ultimately lead to more individualized and at the same time more evidence-based treatment recommendations that take into account the complex interplay of different and sometimes contradictory patient- and tumor-specific factors.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 positive • HR positive • HER-2 negative • PTEN mutation + HR positive
    1m
    ELEMENT: Evaluating the Addition of Elacestrant (Oral SERD) to Olaparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer (clinicaltrials.gov)
    P2, N=176, Recruiting, German Breast Group | Not yet recruiting --> Recruiting | Trial completion date: Mar 2028 --> Dec 2028 | Initiation date: Mar 2024 --> Oct 2024 | Trial primary completion date: Mar 2028 --> Dec 2028
    Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset)
    |
    BRCA2 mutation • BRCA1 mutation • HER-2 negative • PTEN mutation + HR positive
    |
    Lynparza (olaparib) • Orserdu (elacestrant)
    1m
    Neoadjuvant sunitinib plus exemestane in post-menopausal women with hormone receptor-positive/HER2-negative early-stage breast cancer (SUT_EXE-08): a phase I/II trial. (PubMed, Sci Rep)
    P2; Sunitinib plus exemestane was associated with substantial yet reversible toxicities, providing safety, efficacy and biological impact insights of combining an antiangiogenic drug with hormone therapy in early-stage breast cancer.Trial registration: Registered with ClinicalTrials.gov, NCT00931450. 02/07/2009.
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • KDR (Kinase insert domain receptor) • FOXC1 (Forkhead Box C1) • SFRP1 (Secreted frizzled related protein 1)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative • PTEN mutation + HR positive
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    sunitinib • exemestane
    1m
    Capivasertib and fulvestrant for patients with HR-positive/HER2-negative advanced breast cancer: analysis of the subgroup of patients from Japan in the phase 3 CAPItello-291 trial. (PubMed, Breast Cancer)
    Outcomes in the Japan subgroup were broadly similar to those of the global population, supporting the clinical benefit of capivasertib-fulvestrant in treating HR-positive/HER2-negative advanced breast cancer that has progressed on, or after, an endocrine-based regimen.
    P3 data • Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • AKT1 (V-akt murine thymoma viral oncogene homolog 1)
    |
    HER-2 positive • HR positive • HER-2 negative • EGFR positive • HR positive + HER-2 negative • PTEN mutation + HR positive
    |
    fulvestrant • Truqap (capivasertib)
    1m
    Impact of low HER2 expression on response to CDK4/6 inhibitor treatment in advanced HR + /HER2- breast cancer: a multicenter real-world data analysis. (PubMed, Arch Gynecol Obstet)
    In our analysis, HER2 status did not have a significant impact on treatment response to CDK4/6i.
    Journal • Real-world evidence • Real-world • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HER-2 expression • HR positive + HER-2 negative • PTEN mutation + HR positive
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki)
    1m
    Clinical Outcomes of Patients Treated with Ribociclib in Combination with Aromatase Inhibitors or Fulvestrant for HR-Positive, HER2-Negative Metastatic Breast Cancer, Real-World Data from a Low-Resourced Country. (PubMed, Immunotargets Ther)
    In real-world settings, and away from the stringency of controlled clinical trials, endocrine therapy in combination with ribociclib in patients with HR-positive/HER2-negative MBC is an effective and well-tolerated therapy with a manageable toxicity profile and a low drug discontinuation rate. Dose reduction due to toxicity did not worsen the outcome.
    Clinical • Clinical data • Journal • Combination therapy • 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
    |
    Kisqali (ribociclib) • fulvestrant
    1m
    Neoadjuvant letrozole and palbociclib in patients with HR-positive/HER2-negative early breast cancer and Oncotype DX Recurrence Score ≥18: DxCARTES study. (PubMed, ESMO Open)
    The efficacy of neoadjuvant treatment with letrozole plus palbociclib does not seem to depend on pretreatment RS for patients with RS ≥18. However, around half of patients with HR-positive/HER2-negative early breast cancer with an RS 26-100 at baseline achieved molecular downstaging with this regimen.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive • HER-2 negative • EGFR positive • HR positive + HER-2 negative • PTEN mutation + HR positive
    |
    Oncotype DX Breast Recurrence Score®Test
    |
    Ibrance (palbociclib) • letrozole • goserelin acetate
    1m
    A genome-wide CRISPR/Cas9 knockout screen identifies SEMA3F gene for resistance to cyclin-dependent kinase 4 and 6 inhibitors in breast cancer. (PubMed, Breast Cancer)
    Our observation provided the first evidence of SEMA3F as a regulator of sensitivity to CDK4/6 inhibitors in breast cancer. The detailed mechanisms of resistance deserve further functional studies to develop the better strategy to overcome resistance in CDK4/6 inhibitors.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • CDK4 (Cyclin-dependent kinase 4) • SEMA5A (semaphorin 5A)
    |
    HER-2 positive • HR positive • HER-2 negative • EGFR positive • HR positive + HER-2 negative • PTEN mutation + HR positive
    |
    Ibrance (palbociclib)
    1m
    ROSE: Study of Quality of Life and Hormone Levels in Premenopausal Participants With Early Breast Cancer Receiving Triptorelin Plus Additional Cancer Treatment (clinicaltrials.gov)
    P=N/A, N=419, Recruiting, Ipsen | Trial completion date: Dec 2025 --> Mar 2026 | Trial primary completion date: Dec 2025 --> Mar 2026
    Trial completion date • Trial primary completion date • HEOR
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
    |
    BRCA1 mutation • HR positive • HER-2 negative • HR positive + HER-2 negative • BRCA mutation • PTEN mutation + HR positive
    |
    triptorelin
    1m
    A Randomized, Open-label, Multi-center Phase IV Study Evaluating Palbociclib Plus Endocrine Treatment Versus a Chemotherapy-based Treatment Strategy in Patients With Hormone Receptor Positive / HER2 Negative Breast Cancer in a Real World Setting (GBG 93 - PADMA Study). (clinicaltrials.gov)
    P4, N=130, Completed, German Breast Group | Recruiting --> Completed | Trial completion date: Mar 2023 --> Aug 2024 | Trial primary completion date: Mar 2023 --> Aug 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative • PTEN mutation + HR positive
    |
    Ibrance (palbociclib) • paclitaxel • tamoxifen • capecitabine • fulvestrant • letrozole • epirubicin • vinorelbine tartrate • exemestane
    2ms
    Eribulin plus carboplatin combination for HER2-negative metastatic breast cancer: a multicenter, real-world cohort study. (PubMed, BMC Cancer)
    ErCb demonstrated favorable efficacy and tolerability in patients with heavily pre-treated mBC, especially TNBC. The findings of the current study warrant further investigation of the application of this combination in earlier lines of mBC treatment.
    Journal • Real-world evidence • Real-world • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • PTEN mutation + HR positive
    |
    carboplatin • Halaven (eribulin mesylate)
    2ms
    Neoadjuvant Chemotherapy with Concurrent Letrozole for Estrogen Receptor-Positive and HER2-Negative Breast Cancer: An Open-Label, Single-Center, Nonrandomized Phase II Study (NeoCHAI). (PubMed, Cancers (Basel))
    The addition of letrozole to standard neoadjuvant chemotherapy was safe and beneficial in terms of overall response rate, but did not provide a higher pCR rate in locally advanced HR-positive, HER2-negative breast cancer. Further research is needed to enhance neoadjuvant treatment strategies for this cancer subtype.
    P2 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HR positive • HER-2 negative • ER positive + HER-2 negative • PTEN mutation + HR positive • HER-2 negative + ER positive
    |
    letrozole
    2ms
    Canadian Expert Recommendations on Safety Overview and Toxicity Management Strategies for Sacituzumab Govitecan Based on Use in Metastatic Triple-Negative Breast Cancer. (PubMed, Curr Oncol)
    Sacituzumab Govitecan (SG) is an antibody-drug conjugate (ADC) comprised of an anti-Trop-2 IgG1 molecule conjugated to SN-38, the active metabolite of irinotecan, via a pH-sensitive hydrolysable linker. The most common AEs were neutropenia, diarrhea, nausea, fatigue, alopecia, and anemia. This review outlines AE management recommendations for SG based on clinical trial protocols and Canadian guidelines, incorporating treatment delay, dose reductions, and the use of prophylactic and supportive medications.
    Review • Journal • Adverse events • 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
    |
    irinotecan • Trodelvy (sacituzumab govitecan-hziy)
    2ms
    Clinicopathological features, treatment patterns, and survival outcomes among Syrian patients with advanced breast cancer. (PubMed, Front Oncol)
    In the HR-positive/HER2-negative group, PFS for endocrine therapy was significantly longer than chemotherapy, with no differences in OS. This study confirms that endocrine therapy is preferred as an FLx for ABC in the HR-positive/HER2-negative group.
    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
    2ms
    Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6) (clinicaltrials.gov)
    P3, N=312, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting
    Enrollment closed • Circulating tumor DNA
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HR positive • HER-2 negative • ER mutation • ESR1 mutation • HR positive + HER-2 negative • PTEN mutation + HR positive • HER-2 negative + ER positive • HER-2 negative + ER positive + ESR1 mutation • HER-2 negative + HR positive + ESR1 mutation
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • letrozole • anastrozole • camizestrant (AZD9833)
    2ms
    CHANGEABLE: Combination of HX008 And Niraparib in GErm-line-mutAted Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=37, Completed, Fudan University | Recruiting --> Completed
    Trial completion • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • PTEN (Phosphatase and tensin homolog) • BAP1 (BRCA1 Associated Protein 1) • CDK12 (Cyclin dependent kinase 12) • CHEK2 (Checkpoint kinase 2) • FANCA (FA Complementation Group A) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • RAD50 (RAD50 Double Strand Break Repair Protein) • RAD51D (RAD51 paralog D) • CHEK1 (Checkpoint kinase 1) • BARD1 (BRCA1 Associated RING Domain 1) • NBN (Nibrin Nijmegen Breakage Syndrome 1 (Nibrin)) • FANCF (FA complementation group F) • WRN (WRN RecQ Like Helicase) • FANCM (FA Complementation Group M) • FANCD2 (FA Complementation Group D2) • FANCE (FA Complementation Group E) • FANCC (FA Complementation Group C)
    |
    HER-2 positive • BRCA2 mutation • BRCA1 mutation • HR positive • HER-2 negative • ATM mutation • PALB2 mutation • CDK12 mutation • BAP1 mutation • CHEK2 mutation • BRIP1 mutation • RAD51C mutation • FANCA mutation • HR positive + HER-2 negative • RAD50 mutation • BARD1 mutation • BLM mutation • CHEK1 mutation • FANCF mutation • MRE11A mutation • NBN mutation • FANCM mutation • PTEN mutation + HR positive • CHEK1 expression • HER-2 negative + HR positive + BRCA mutation
    |
    Herceptin (trastuzumab) • Zejula (niraparib) • Puyouheng (pucotenlimab)
    2ms
    A Multi-Center, Open-Label Study of Fruquintinib in Solid Tumors and Colorectal, and Breast Cancers (clinicaltrials.gov)
    P1, N=129, Completed, Hutchison Medipharma Limited | Active, not recruiting --> Completed
    Trial completion • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • RAS wild-type • PTEN mutation + HR positive
    |
    Fruzaqla (fruquintinib)
    2ms
    YL202-INT-101-01: A Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast Cancer (clinicaltrials.gov)
    P1, N=80, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Active, not recruiting --> Recruiting | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2025
    Enrollment open • Trial completion date • Trial primary completion date • Metastases
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
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    EGFR mutation • HR positive • HER-2 negative • EGFR L858R • EGFR exon 19 deletion • HR positive + HER-2 negative • PTEN mutation + HR positive
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    BNT326
    2ms
    Fulvestrant en la práctica clínica: análisis de efectividad en pacientes uruguayas con cáncer de mama HR+/HER2. (PubMed, Medwave)
    The presence of liver and bone metastases was associated with worse prognosis and survival; additionally, patients with worse performance status had shorter overall survival. These findings underscore the need for personalized therapies, opening new lines of future research.
    Journal
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    HER-2 (Human epidermal growth factor receptor 2)
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    HR positive • HER-2 negative • HR positive + HER-2 negative • PTEN mutation + HR positive
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    fulvestrant
    2ms
    The impact of body mass index on the progression-free survival of CDK 4/6 inhibitors in metastatic breast cancer patients. (PubMed, Future Oncol)
    Comparisons of PFS and BMI categories were performed by Kaplan-Meier curve and log-rank test. PFS was 9.3 (5.3-13.4) months in normal weight patients and 11.1 (9.7-12.56) months in obese patients and was not reached in overweight patients. This difference was statistically significant (p = 0.02). Low BMI has been shown to have a negative prognostic effect on survival in patients with metastatic breast cancer and overweight patients had a longer PFS.
    Journal • Metastases
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 positive • HR positive • HER-2 negative • PTEN mutation + HR positive
    2ms
    ASO Author Reflections: Breast-Conserving Surgery After Neoadjuvant Systemic Therapy for Early-Stage Breast Cancer: Quantitative Biomarkers and Disparities in the Precision-Medicine Era. (PubMed, Ann Surg Oncol)
    With the evolving landscape of neoadjuvant therapies in development for HR-positive/HER2-negative breast cancer, ongoing work using quantitative biomarkers and genomic assay scores is needed to select the right neoadjuvant systemic therapy for the right patient. Given the increasing amount of data available at the time of breast cancer diagnosis, novel computational approaches are needed to integrate patient demographic and tumor-specific factors to predict the optimal treatment strategy and likelihood of BCS.
    Journal • Surgery
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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    HER-2 positive • HR positive • HER-2 negative • EGFR positive • HR positive + HER-2 negative • PGR expression • PTEN mutation + HR positive • HER-2 negative + ER positive
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    Oncotype DX Breast Recurrence Score®Test
    2ms
    Effectiveness of combined targeted and hormonal therapies for post-menopausal women with hormone receptor-positive and HER2-negative advanced breast cancer: A systematic review and meta-analysis of RCTs. (PubMed, J Oncol Pharm Pract)
    Compared with hormonal monotherapy, targeted plus hormonal therapy significantly improves PFS, OS and ORR in postmenopausal women with HR+/HER2- advanced breast cancer.
    Retrospective data • Review • Journal • Metastases
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative • PTEN mutation + HR positive