Perjeta (pertuzumab) / Roche 
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 80 Diseases   208 Trials   208 Trials   5617 News 


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  • ||||||||||  Kadcyla (ado-trastuzumab emtansine) / Roche
    Clinical, Journal:  Trastuzumab emtansine for HER2-positive metastatic breast cancer: Outcomes from a whole-of-population Australian cohort. (Pubmed Central) -  Oct 20, 2021   
    More research is needed to better understand risk factors for BM and survival after BM in the context of HER2+ BC, as well as the assessment of new anti-HER2 therapy regimens that may provide additional therapeutic options for BM in these patients. Our findings highlight differences in patient characteristics (older, more previous pertuzumab therapy) and outcomes (shorter OS) from the T-DM1 pivotal trial and provide real-world estimates that can inform patient, clinician and policy, decisions around the use of HER2-targeted therapies in routine clinical care.
  • ||||||||||  Herceptin (trastuzumab) / Roche, Nerlynx (neratinib) / Puma, Knight Therap, Pierre Fabre
    [VIRTUAL] Neratinib for treatment of leptomeningeal metastases from HER2-positive breast cancer in extended access program: preliminary results () -  Oct 10, 2021 - Abstract #EANO2021EANO_306;    
    Patients and Inclusion criteria were as follows: age ≥ 18 years; histological diagnosis of primary HER2-positive BC; newly-diagnosed LM according to LANO criteria; KPS ≥60 at the time of diagnosis of LM; coexistence of BM that have or not received WBRT or radiosurgery; systemic disease with a life expectancy of at least 3 months; concomitant drugs, including capecitabine, trastuzumab, TDM-1, pertuzumab, and hormone therapy were allowed, with the exclusion of lapatinib or other investigational agents... This is the first study that shows that neratinib might be a safe and effective treatment in LM from heavily pretreated HER2-positive BC.
  • ||||||||||  Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
    A phase 3, open-label trial of neoadjuvant trastuzumab deruxtecan (T-DXd) monotherapy or T-DXd followed by THP compared with ddAC-THP in patients with high-risk HER2-positive early-stage breast cancer (DESTINY-Breast11) (Hall 1) -  Oct 9, 2021 - Abstract #SABCS2021SABCS_279;    
    Here, we describe a phase 3 trial evaluating the efficacy, safety, and tolerability of T-DXd monotherapy or T-DXd followed by paclitaxel + trastuzumab + pertuzumab (THP) vs dose-dense doxorubicin + cyclophosphamide followed by THP (ddAC-THP) in patients with high-risk HER2-positive EBC...For patients who do not achieve a pCR, therapy with up to 14 cycles of trastuzumab emtansine is recommended...Secondary endpoints include pCR (ypT0 ypN0) (defined as absence of invasive and in situ cancer in the breast and sampled regional lymph nodes) by central review as well as 3-year event-free survival, 3-year invasive disease-free survival, overall survival, patient-reported tolerability, physical functioning, immunogenicity, pharmacokinetics, and safety. Exploratory endpoints include 3-year distant metastasis-free survival, objective response rate, rate of breast-conserving surgery, biomarkers, patient-reported outcomes, and healthcare resource utilization.
  • ||||||||||  tamoxifen / Generic mfg.
    A phase 2 study of chemotherapy de-escalation using a pathological response-guided strategy in patients with HER2-positive, low-risk early breast cancer: PHERGain-2 (Hall 1) -  Oct 9, 2021 - Abstract #SABCS2021SABCS_278;    
    Background: The introduction of trastuzumab (H) and pertuzumab (P) and ado-trastuzumab emtansine (T-DM1) has drastically improved clinical outcomes in patients (pts) with HER2-positive early breast cancer, allowing to explore chemotherapy-sparing approaches in this population...Hormone receptor-positive pts will be additionally given letrozole (2.5 mg/day orally) if postmenopausal or tamoxifen (20 mg/day orally) plus gonadotropin-releasing hormone analogue if pre-/peri-menopausal or men...The analysis for the primary efficacy and safety endpoints will be conducted with 95% confidence intervals based on Kaplan-Meier estimator. This trial was opened to accrual in May 2021.
  • ||||||||||  IO beyond TNBC (Hall 3) -  Oct 9, 2021 - Abstract #SABCS2021SABCS_163;    
    P1, P2, P3
  • ||||||||||  Approving new therapies (Stars at Night Ballroom 3&4) -  Oct 9, 2021 - Abstract #SABCS2021SABCS_106;    
    Pertuzumab, neratinib, ado-trastuzumab emtansine and pembrolizumab have all received approvals for treatment of breast cancer in the neo/adjuvant setting over the last decade. Some of these approvals will be discussed to highlight various efficacy endpoints and clinical trial design features that may be used in the early breast cancer setting.
  • ||||||||||  paclitaxel / Generic mfg.
    Escalating and de-escalation - titrating the right regimen in early stage HER2 positive (Stars at Night Ballroom 1&2) -  Oct 9, 2021 - Abstract #SABCS2021SABCS_40;    
    Regarding de-escalation, TBCRC0023, one of the first chemotherapy-free de-escalation studies in HER2+ EBC, looked at duration of neoadjuvant trastuzumab and lapatinib - in HR+ tumors together with letrozole (+ GNRH if premenopausal)...In TP II, 12x weekly paclitaxel + trastuzumab + pertuzumab achieved a total pCR rate of 57%, whereas the antibodies alone + ET rendered 24%...As demonstrated in ADAPT TP, HER2-enriched subtype is associated with high pCR rates after HER-targeting regimens whereas luminal A and B subtypes have lower pCR rates. In luminal tumors, survival endpoints may thus be more appropriate to fully evaluate de-escalated regimens.In clinical routine, individualized therapy concepts including therapy de-escalation and escalation should always be evidence-based in order not to jeopardize the already excellent survival rates we have achieved over the last decade in HR+ HER2+ EBC.
  • ||||||||||  Review, Journal:  Neu Perspectives, Therapies, and Challenges for Metastatic HER2-Positive Breast Cancer. (Pubmed Central) -  Oct 5, 2021   
    What these observations suggest is that while tumor response may be partially linked to uncoupling cell surface message reception and nuclear gene expression, as well as recruitment of the innate immune system, disease progression and/or resistance may involve a reprogrammable signaling mainframe that elicits alternative growth and survival signals. This review attempts to meld current perceptions related to HER2-positive metastatic breast cancer with particular attention to current biological insights and therapeutic challenges.
  • ||||||||||  Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
    Trial completion date:  NSABP Biospecimen Discovery Project (clinicaltrials.gov) -  Oct 5, 2021   
    P=N/A,  N=50, Active, not recruiting, 
    PROs have value as prognostic and stratification factors for clinical use and research trials of anti-cancer medicines in HER2-positive advanced breast cancer. Trial completion date: Oct 2024 --> Feb 2022
  • ||||||||||  Herceptin (trastuzumab) / Roche, Opdivo (nivolumab) / Ono Pharma, BMS
    Clinical, Review, Journal:  Improving Biologics' Effectiveness in Clinical Oncology: From the Combination of Two Monoclonal Antibodies to Oligoclonal Antibody Mixtures. (Pubmed Central) -  Sep 29, 2021   
    Combined formulations have also been developed in which separately produced antibodies are mixed before administration or are produced simultaneously in a single cell line or a single batch of different cell lines as a polyclonal master cell bank. The regulation, toxicity and injection sequence of these oligoclonal antibody mixtures still need to be addressed in order to optimize their delivery and their therapeutic effects.
  • ||||||||||  Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
    Clinical, Journal, Real-world evidence:  Real world study of pertuzumab-trastuzumabchemotherapy versus trastuzumab-chemotherapy in neoadjuvant treatment of breast cancer. (Pubmed Central) -  Sep 24, 2021   
    Furthermore, it may enable identification of patients at higher risk of developing cardiotoxicity and identification of those most likely to respond to cardioprotective therapy. For patients with HER2 positive tumors and negative hormonal receptors with high risk criteria that receive  pertuzumab, the complete pathological response is superior, with no  increase in cardiac toxicity.
  • ||||||||||  Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  PREDIX II HER2: Improving Pre-operative Systemic Therapy for Human Epidermal Growth Factor Receptor 2 (HER2) Amplified Breast Cancer (clinicaltrials.gov) -  Sep 23, 2021   
    P2,  N=6, Terminated, 
    For patients with HER2 positive tumors and negative hormonal receptors with high risk criteria that receive  pertuzumab, the complete pathological response is superior, with no  increase in cardiac toxicity. N=190 --> 6 | Trial completion date: Dec 2034 --> Jun 2021 | Suspended --> Terminated | Trial primary completion date: Dec 2024 --> Jun 2021; Security and effect data from another ongoing study.