Perjeta (pertuzumab) / Roche 
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  • ||||||||||  Perjeta (pertuzumab) / Roche, inavolisib (GDC-0077) / Roche
    GeparPiPPa- A randomized, open-label, phase II trial comparing neoadjuvant trastuzumab, pertuzumab and endocrine therapy +/- the PI3K inhibitor inavolisib in patients (pts) with HER2+/HR+, PIK3CA mutant early breast cancer (BC) (Room A2) -  Nov 30, 2022 - Abstract #DKK2022DKK_1856;    
    The phase III Solar-1 study demonstrated a sig- nificant improvement in progression-free survival with the addition of alpelisib to fulvestrant in PIK3CA mutant metastatic BC (André F 2019)...170 pts with cT1c – cT3 early BC, centrally confirmed HER2+ and HR+-status as well as a PIK3CA tumor mutation (by NGS) will be randomized 1:1 to receive 6 cycles of tamoxifen or an aromatase inhibitor (1x1/d orally, day 1-21 q3w) +/- gonadotropin-releasing hor- mone analogue plus pertuzumab/trastuzumab (subcutaneous formula- tion [1200 (600) mg/600 mg on d1, q3w]) without or with inavolisib (9mg 1x1/d orally, day 1-21 q3w)...Secondary endpoints include com- parison of other pCR definitions, invasive disease-free survival, overall survival, and safety. Further (neo)adjuvant systemic treatment and radio- therapy will be administered at the discretion of the investigator accord- ing to standard of care.
  • ||||||||||  Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
    Anthracycline versus no anthracycline neoadjuvant therapy for HER2 breast cancer: real world evidence (Exhibition Hall) -  Nov 23, 2022 - Abstract #EBCC2022EBCC_373;    
    Our study included patients treated with neoadjuvant therapy with double anti-HER2 blockade with trastuzumab and pertuzumab and chemotherapy followed by surgery...Results A total of 287 women were included, with 227 in the anthracycline group (mean age of 52.8) and 60 in the non-anthracycline group - carboplatin, docetaxel and double blockade (TCHP) (mean age of 51)...Conclusion Our pilot study adds new evidence about the efficacy of TCHP compared to an anthracycline-based regimen for HER2+ EBC. Both groups had young patients with similar median ages and few comorbidities , setting up an important rationale in favor of de-escalation with TCHP in this subgroup, thus avoiding the anthracycline-related toxicities.
  • ||||||||||  Irene (pyrotinib) / Jiangsu Hengrui Pharma, Herceptin (trastuzumab) / Roche
    PyrotInib in combination with Capecitabine for trasTUzumab-REsistant, HER2-positive advanced breast cancer (PICTURE): a multicenter phase 2 trial (Hall 1) -  Nov 22, 2022 - Abstract #SABCS2022SABCS_2029;    
    P2
    Pyrotinib plus capecitabine resulted in a promising PFS that crossed the pre-specified efficacy boundary in patients with HER2-positive advanced breast cancer who met the traditional definition of primary trastuzumab resistance. Patients in Group 2 had a significant longer PFS than those in either Group 1 or Group 3, highlighting the need to re- define primary trastuzumab resistance and to clarify efficacy of new anti-HER2 biologicals for each subpopulation.
  • ||||||||||  Perjeta (pertuzumab) / Roche
    Journal:  Designing a humanized immunotoxin based on DELTA-stichotoxin-Hmg2a toxin: an in silico study. (Pubmed Central) -  Nov 20, 2022   
    In the current study, we designed and evaluated an immunotoxin composed of pertuzumab and DELTA-stichotoxin-Hmg2a-derived scFv by bioinformatics tools...The analysis results indicated that the construct is a stable protein that could have a natural-like structure and would not be an allergen, so this immunotoxin could effectively target HER2 receptors. Therefore, our designed immunotoxin could be an appropriate immunotoxin against HER2-positive breast cancer and could be a challenging topic for future in vitro and in vivo studies.
  • ||||||||||  sabizabulin (VERU-111) / Veru Inc
    Journal:  Sabizabulin, a Potent Orally Bioavailable Colchicine Binding Site Agent, Suppresses HER2+ Breast Cancer and Metastasis. (Pubmed Central) -  Nov 16, 2022   
    In vivo, sabizabulin inhibits breast tumor growth in the BT474 (ER+/PR+/HER2+) xenograft model and a HER2+ (ER-/PR-) metastatic patient-derived xenograft (PDX) model, HCI-12. We demonstrate that sabizabulin is a promising alternative agent to target tubulin in HER2+ breast cancer with similar anti-metastatic efficacy to paclitaxel, but with the advantage of oral bioavailability and lower toxicity than taxanes.
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS
    Enrollment closed, Trial completion date, Trial primary completion date:  Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC) (clinicaltrials.gov) -  Nov 15, 2022   
    P2,  N=8, Active, not recruiting, 
    We demonstrate that sabizabulin is a promising alternative agent to target tubulin in HER2+ breast cancer with similar anti-metastatic efficacy to paclitaxel, but with the advantage of oral bioavailability and lower toxicity than taxanes. Completed --> Active, not recruiting | Trial completion date: Jan 2021 --> May 2023 | Trial primary completion date: Jan 2021 --> May 2023
  • ||||||||||  Ibrance (palbociclib) / Pfizer
    Trial completion date, Trial primary completion date, Combination therapy:  To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Breast Cancer (TOUCH) (clinicaltrials.gov) -  Nov 10, 2022   
    P2,  N=144, Active, not recruiting, 
    The addition of trastuzumab/pertuzumab to perioperative FLOT significantly improved pCR and nodal negativity rates at the price of higher rates of diarrhea and leukopenia. Trial completion date: Nov 2022 --> Mar 2023 | Trial primary completion date: Nov 2022 --> Mar 2023
  • ||||||||||  Perjeta (pertuzumab) / Roche, Tecentriq (atezolizumab) / Roche
    Journal:  C-Terminal Lysine Processing of IgG in Human Suction Blister Fluid: Implications for Subcutaneous Administration. (Pubmed Central) -  Nov 9, 2022   
    The impact of CTK content (even up to 100%) on SC PK outcomes such as bioavailability and C were modest (<14%) for all combinations of PK parameters tested in the sensitivity analysis. This study forms the cornerstone data package for derisking CTK as a PK liability for antibody SC programs and highlights the usefulness of fully considering biotransformation during product quality criticality assessments.
  • ||||||||||  Trial primary completion date, Tumor mutational burden, Pan tumor:  Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (clinicaltrials.gov) -  Nov 9, 2022   
    P2,  N=720, Recruiting, 
    The addition of pertuzumab to the TH regimen in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer has a low probability of being cost-effective from the payer's perspective in the Colombian health system. Trial primary completion date: Sep 2022 --> Jun 2023