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80 Diseases |  |
201 Trials |
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201 Trials |  |
5515 News |  |
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- | Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
New P1 trial, Combination therapy, Metastases: A Study of Allogenic Natural Killer Cells in Combination With Trastuzumab and Pertuzumab in Adult Patients With Refractory Metastatic Her2 Positive Breast Cancer. NK-ACT-BC_2020 (clinicaltrials.gov) - May 23, 2022
P1, N=20, Recruiting, Sponsor: Vall d'Hebron Institute of Oncology
- || Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
@ASCO TAPUR has reported positive cohort for Pertuzumab+Trastuzumab in ERBB2 amplified CRC at 2020 GI Symposium. Full manuscript coming soon! (Twitter) - May 20, 2022
- | imlunestrant (LY3484356) / Eli Lilly
Trial completion date, Combination therapy, Monotherapy, Metastases: EMBER: A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer (clinicaltrials.gov) - May 20, 2022
P1a/1b, N=500, Recruiting, Sponsor: Eli Lilly and Company
Trial completion date: Apr 2023 --> Dec 2023
- | Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Trial completion date: Paclitaxel + Trastuzumab + Pertuzumab as Pre-Op for Inflammatory BrCa (clinicaltrials.gov) - May 19, 2022
P2, N=23, Active, not recruiting, Sponsor: Dana-Farber Cancer Institute
Trial completion date: Apr 2023 --> Dec 2023 Trial completion date: Mar 2022 --> Mar 2023
- | Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca, Perjeta (pertuzumab) / Roche
Retrospective data, Journal, HEOR: Comparative effectiveness and tolerability of targeted agents combined with chemotherapy in patients with HER2-positive gastroesophageal cancer: A network meta-analysis. (Pubmed Central) - May 19, 2022
The trastuzumabderuxtecan (TraD) and pertuzumab plus trastuzumab and chemotherapy (PerTraChemo) regimens were considered to have high effectiveness but low tolerability...As the second- or third-line therapy, TraD and lapatinib plus chemotherapy (LapChemo) had high effectiveness and moderate tolerability...TraD had relative advantages as the second- or third-line therapy and in the IHC3 + population. PerTraChemo is a potential first-line therapy, but it requires further confirmation because the JACOB phase III clinical trial failed to confirm the superiority of PerTraChemo over TraChemo with regard to OS.
- | Ibrance (palbociclib) / Pfizer, Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Journal: Modulation of the estrogen/erbB2 receptors crosstalk by CDK4/6 inhibition triggers sustained senescence in estrogen receptor and erbB2 positive breast cancer. (Pubmed Central) - May 18, 2022
P2
MTORC1 pathway activation is a potential mechanism of escape and RTKs functional activation may be an alternative pathway for survival also in ER+/HER2low tumor. PFHPert combination is an effective chemotherapy-free regimen for ER+/HER2+ BC and the mechanistic elucidation of sensitivity/resistance patterns may provide insights for further treatment refinement.
- | Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) / Roche, Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Trial initiation date: NRG-GY026: Testing the Addition of Trastuzumab or Trastuzumab/Pertuzumab to the Usual Chemotherapy for HER2 Positive Endometrial Serous Carcinoma or Carcinosarcoma (clinicaltrials.gov) - May 18, 2022
P2/3, N=326, Not yet recruiting, Sponsor: National Cancer Institute (NCI)
PFHPert combination is an effective chemotherapy-free regimen for ER+/HER2+ BC and the mechanistic elucidation of sensitivity/resistance patterns may provide insights for further treatment refinement. Initiation date: May 2022 --> Aug 2022
- ||| Perjeta (pertuzumab) / Roche
Pertuzumab same story . Once they see the use increased price goes up #roche (Twitter) - May 18, 2022
- |||| HLX11 (pertuzumab biosimilar) / Fosun Pharma, Organon
Trial primary completion date, Metastases: A Study to Evaluate the Efficacy and Safety of HLX11 vs. EU-Perjeta (clinicaltrials.gov) - May 17, 2022
P3, N=900, Recruiting, Sponsor: Shanghai Henlius Biotech
Initiation date: May 2022 --> Aug 2022 Trial primary completion date: Dec 2023 --> Nov 2024
- ||| Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Absolutely- anti-HER2 mAbs do have intracranial activity! The benchmark for me is this great study led by @nlinmd, where pertuzumab + HD trastuzumab achieved 11% CNS ORR. https://t.co/qSvX51SkhA (Twitter) - May 17, 2022
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
PATHOLOGIC COMPLETE RESPONSE RATE ANALYSIS OF HORMONE RECEPTOR NEGATIVE BREAST CANCER WITH RADIOLOGIC COMPLETE RESPONSE AFTER NEOADJUVANT CHEMOTHERAPY () - May 16, 2022 - Abstract #GBCC2022GBCC_376;
Its effectiveness has been proven in previous studies. We confirmed that age and HER2 positivity is the predictive factor of pathologic CR among radiologic CR patients.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
ADJUVANT TARGET THERAPY FOR PATIENTS WITH HER2 POSITIVE BREAST CANCER ACHIEVING PATHOLOGICAL COMPLETE RESPONSE AFTER NEOADJUVANT THERAPY () - May 16, 2022 - Abstract #GBCC2022GBCC_375;
The clinical benefit of adjuvant dual blockade as trastuzumab and pertuzumab remained unknown in patients achieving pathological complete response (pCR). Our findings concluded that there was no significant difference between adjuvant dual blockade therapy and adjuvant single blockade therapy in HER2 positive breast cancer patients achieving pCR after NAC.
- Herceptin (trastuzumab) / Roche
REAL WORLD EXPERIENCE IN TRASTUZUMAB BIOSIMILARS FOR BREAST CANCER IN TAIWAN () - May 16, 2022 - Abstract #GBCC2022GBCC_374;
The efficacy of biosimilar trastuzumab is noted in neoadjuvant settings. For metastatic settings, dual blockade results in better disease control.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche, Tecentriq (atezolizumab) / Roche
A PHASE 2 STUDY OF NEOADJUVANT PERTUZUMAB, ATEZOLIZUMAB, DOCETAXEL AND TRASTUZUMAB IN HER2-POSITIVE EARLY BREAST CANCER (NEO-PATH, KCSG BR 18-23) (RM 4(Walker Hall 2)) - May 16, 2022 - Abstract #GBCC2022GBCC_255;
Neoadjuvant PATH regimen showed favorable efficacy and safety profiles in stage II-III HER2-positive EBC, Luminal subtype and MYC amplification were associated with worse response. NEO-PATH provides evidence of combining immunotherapy and anti-HER2 treatment as a potential new therapeutic option.
- | Trial initiation date: Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer (clinicaltrials.gov) - May 16, 2022
P2, N=185, Not yet recruiting, Sponsor: Baylor Breast Care Center
NEO-PATH provides evidence of combining immunotherapy and anti-HER2 treatment as a potential new therapeutic option. Initiation date: Oct 2021 --> Jun 2022
- | Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Journal: A prospective trial of treatment de-escalation following neoadjuvant paclitaxel/trastuzumab/pertuzumab in HER2-positive breast cancer. (Pubmed Central) - May 12, 2022
P1
De-escalation of adjuvant chemotherapy among patients who experience pCR in early-stage HER2+ breast cancer is a practicable approach for both patients and physicians. Planned and ongoing prospective trials will determine the long-term efficacy of this approach.Trial registration clinicaltrials.gov, NCT03716180, https://clinicaltrials.gov/ct2/show/NCT03716180 .
- |||| Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Clinical: The combination of trastuzumab & pertuzumab is a standard treatment for advanced-stage & for most early-stage HER2+ breast cancers. Here, @stolaney1 discusses a new subcutaneous formulation, allowing to retain its efficacy but improve comfort of injection. https://t.co/v34WLYxcly (Twitter) - May 12, 2022
- | Perjeta (pertuzumab) / Roche
Journal: Drifts in N-Linked Glycosylation Result in ADCC Potency Variation of Perjeta® from August 2020 to October 2021 in China. (Pubmed Central) - May 12, 2022
In detail, four parametric curves of ADCC activity of the reference product were unparalleled, and the maximum response value was highly related to the content of %afucose than half-maximal effective concentration (EC). As ADCC is a potential critical quality attribute of Perjeta®, the glycosylation of Perjeta® and its biosimilars should be tightly monitored and controlled.
- || Tukysa (tucatinib) / Pfizer, Kisqali (ribociclib) / Novartis, Perjeta (pertuzumab) / Roche
Enrollment open, Metastases: UCLA B-13: Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer (clinicaltrials.gov) - May 12, 2022
P1b, N=18, Recruiting, Sponsor: Jonsson Comprehensive Cancer Center
As ADCC is a potential critical quality attribute of Perjeta®, the glycosylation of Perjeta® and its biosimilars should be tightly monitored and controlled. Not yet recruiting --> Recruiting
- ||| Piqray (alpelisib) / Novartis
Trial completion date, Combination therapy, Metastases: EPIK-B2: Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation (clinicaltrials.gov) - May 11, 2022
P3, N=511, Recruiting, Sponsor: Novartis Pharmaceuticals
Not yet recruiting --> Recruiting Trial completion date: Feb 2031 --> Sep 2031
- || Trial completion date, Trial primary completion date, Tumor mutational burden, Metastases: TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer (clinicaltrials.gov) - May 10, 2022
P2, N=3581, Recruiting, Sponsor: American Society of Clinical Oncology
Trial completion date: Feb 2031 --> Sep 2031 Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
- | Erbitux (cetuximab) / Eli Lilly, EMD Serono, Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Enrollment closed, Enrollment change, Surgery, Metastases: SWOG S1613: S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery (clinicaltrials.gov) - May 10, 2022
P2, N=240, Active, not recruiting, Sponsor: Southwest Oncology Group
Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024 Recruiting --> Active, not recruiting | N=130 --> 240
- | Perjeta (pertuzumab) / Roche
It also suggests that Pertuzumab addition doesn't change OS . (Twitter) - May 9, 2022
- | Sirturo (bedaquiline) / J&J, Pharmstandard
Journal: Variants associated with Bedaquiline (BDQ) resistance identified in Rv0678 and efflux pump genes in Mycobacterium tuberculosis isolates from BDQ naïve TB patients in Pakistan. (Pubmed Central) - May 6, 2022
We found RAVs in Rv0678 to be commonly associated with BDQ resistance. Further confirmation of the role of variants in efflux pump genes in resistance is required so that they may be incorporated in genome-based diagnostics for drug resistant MTB.
- | Kadcyla (ado-trastuzumab emtansine) / Roche, Perjeta (pertuzumab) / Roche
Retrospective data, Journal: Efficacy of trastuzumab emtansine (T-DM1) and lapatinib after dual HER2 inhibition with trastuzumab and pertuzumab in patient with metastatic breast cancer: Retrospective data from a French multicenter real-life cohort. (Pubmed Central) - May 6, 2022
P=N/A
First-line trastuzumab plus pertuzumab do not markedly diminish T-DM1's efficacy in second-line. Similarly, sequential treatment with trastuzumab plus pertuzumab then T-DM1 does not noticeably modify the efficacy of lapatinib plus capecitabine.
- | Tukysa (tucatinib) / Seagen
Journal: Tucatinib has Selective Activity in HER2-Positive Cancers and Significant Combined Activity with Approved and Novel Breast Cancer-Targeted Therapies. (Pubmed Central) - May 6, 2022
In xenograft models of HER2+ breast cancer that also express estrogen receptor (ER; HER2+/ER+), tucatinib showed combined efficacy with inhibitors of CDK4/6 and ER, indicating potential novel therapeutic strategies for difficult-to-treat subtypes of HER2+ breast cancer. These data support expanded clinical investigations of tucatinib as a combination partner for other novel and approved targeted therapies for HER2-driven malignancies.
- || Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
P2 data, Journal: De-escalated neoadjuvant pertuzumab plus trastuzumab therapy with or without weekly paclitaxel in HER2-positive, hormone receptor-negative, early breast cancer (WSG-ADAPT-HER2+/HR-): survival outcomes from a multicentre, open-label, randomised, phase 2 trial. (Pubmed Central) - May 4, 2022
P2
12 weeks of weekly paclitaxel plus dual HER2 blockade could be an efficacious de-escalated neoadjuvant regimen in patients with hormone receptor-negative, HER2-positive early breast cancer with high pathological complete response rates and good 5-year outcomes. Further trials of this approach are ongoing.
- || Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Review, Journal, BRCA Biomarker, PD(L)-1 Biomarker, IO biomarker: Landmark trials in the medical oncology management of metastatic breast cancer. (Pubmed Central) - Apr 30, 2022
Numerous obstacles still exist in treating MBC, especially for patients whose disease develops resistance to available agents. Future research is eagerly awaited to address the optimal sequence or combination of therapies and to identify better biomarkers to guide precision medicine.
- | Journal: Neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer. (Pubmed Central) - Apr 29, 2022
Regarding de-escalation, the WSG ADAPT trial demonstrated feasibility of avoiding overtreatment and individualizing neoadjuvant therapy without compromising outcome. Further de-escalation trials (e.g. DECRESCENDO, COMPASS-HER2) are currently ongoing.
- | Irene (pyrotinib) / Jiangsu Hengrui Medicine
Journal, Real-world evidence: A real world study on the relationship between drug resistance of targeted therapy and prognosis of HER-2-positive advanced breast cancer (Pubmed Central) - Apr 29, 2022
The median overall survival time of the two groups was 24.9 months and 40.4 months, respectively, with statistical significance (P<0.001). Primary resistance to HER-2 is one of the factors of poor prognosis in HER-2 positive breast cancer, and its mechanism needs to be further explored.
- ||||| trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma, Irene (pyrotinib) / Jiangsu Hengrui Pharma, adebrelimab (SHR-1316) / Jiangsu Hengrui Pharma
New P2 trial, Combination therapy, Metastases: A Phase Ib/II Study of SHR-A1811 Injection in Breast Cancer (clinicaltrials.gov) - Apr 28, 2022
P2, N=402, Not yet recruiting, Sponsor: Jiangsu HengRui Medicine Co., Ltd.
- | Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Journal: Variable-heavy (VH) families influencing IgA1&2 engagement to the antigen, FcαRI and superantigen proteins G, A, and L. (Pubmed Central) - Apr 28, 2022
On their interactions with antigen-Her2 and superantigens PpL, SpG and SpA, PpL was found to sterically hinder Her2 antigen binding with unexpected findings of IgAs binding SpG at the CH2-3 region alongside SpA interacting with IgAs at the CH1. Although the VH3 framework (FWR) is commonly used in CDR grafting, we found the VH1 framework (FWR) to be a possible alternative when grafting IgA1 and 2 owing to its stronger binding to antigen Her2 and weaker interactions to superantigen Protein L and A. These findings lay the foundation to understanding the interactions between IgAs and microbial superantigens, and also guide the engineering of IgAs for future antibody applications and targeting of superantigen-producing microbes.
- || Review, Journal: Developments in the Management of Metastatic HER2-Positive Breast Cancer: A Review. (Pubmed Central) - Apr 28, 2022
In the metastatic setting, prognosis has improved greatly with the use of anti-HER2 drugs such as trastuzumab, pertuzumab, and trastuzumab-emtansine...Systemic treatment of brain metastases in HER2-positive patients and the role of endocrine-based treatment for patients with hormone receptor (HR) positive disease remain areas of research interest. This article will review the current approach to systemic management of metastatic HER2-positive breast cancer in Canada, and present novel treatments that may be available in the near future.
- || Review, Journal: Novel Therapies for the Treatment of HER2-Positive Advanced Breast Cancer: A Canadian Perspective. (Pubmed Central) - Apr 28, 2022
Finally, we have a number of effective anti-HER2 therapies that can be used in subsequent lines of therapy to improve patient outcomes. This review paper discusses the current treatment options and presents a practical treatment sequencing algorithm in the context of the Canadian landscape.
- | Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Trial completion: BrUOG 308: Neoadjuvant Therapy in Clinical Stage I-III HER2-positive Breast Cancer. (clinicaltrials.gov) - Apr 28, 2022
P2, N=32, Completed, Sponsor: Brown University
This review paper discusses the current treatment options and presents a practical treatment sequencing algorithm in the context of the Canadian landscape. Active, not recruiting --> Completed
- | Perjeta (pertuzumab) / Roche
Trial completion date, Trial primary completion date: Testing a New Imaging Agent to Identify Cancer (clinicaltrials.gov) - Apr 28, 2022
P1, N=20, Recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
Active, not recruiting --> Completed Trial completion date: Nov 2022 --> Nov 2024 | Trial primary completion date: Nov 2022 --> Nov 2024
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Real-world data on outcomes using taxane, trastuzumab, and pertuzumab (THP) in patients with early stage HER2+ breast cancer. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_5968;
P1
In addition, with a median follow up of ̃ 3 years, only 3 patients had relapse supporting the utility of THP as potential de-escalation treatment in the neoadjuvant setting. Ongoing prospective trials, like NCT03716180, will further confirm the efficacy of this regimen in a prospective setting.
- Landscape of tumor genetic testing and targeted therapies over an eight-year span in a rural population. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_5324;
Across all tumor types, most patients are being given appropriate targeted therapies as per guidelines. Off-label use of targeted therapy was also observed.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Primary results from JUPITER, a phase 2 basket trial of combination therapy with trastuzumab and pertuzumab in patients with HER2-amplified solid tumors. (Available On Demand; 123) - Apr 28, 2022 - Abstract #ASCO2022ASCO_5168;
Off-label use of targeted therapy was also observed. Combination therapy with trastuzumab and pertuzumab was well tolerated and showed promising efficacy for the patients with HER2-amplified solid tumors determined by NGS.
- Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
Dose-finding and -expansion studies of trastuzumab deruxtecan in combination with other anti-cancer agents in patients (pts) with advanced/metastatic HER2+ (DESTINY-Breast07 [DB-07]) and HER2-low (DESTINY-Breast08 [DB-08]) breast cancer (BC). (Available On Demand; 17) - Apr 28, 2022 - Abstract #ASCO2022ASCO_5062;
P1b, P1b/2
The RP2Ds for the T-DXd combinations were the standard doses for BC of each individual drug. These studies are ongoing, with additional T-DXd combinations being evaluated and further follow-up underway.
- Perjeta (pertuzumab) / Roche
Preliminary analysis of an expanded access study of the fixed-dose combination of pertuzumab (P) and trastuzumab (H) for subcutaneous injection (PH FDC SC) for at-home administration (admin) in patients (pts) with HER2-positive (HER2+) breast cancer (BC) during the COVID-19 pandemic. (Available On Demand; 109) - Apr 28, 2022 - Abstract #ASCO2022ASCO_3981;
P=N/A
These studies are ongoing, with additional T-DXd combinations being evaluated and further follow-up underway. In this preliminary analysis, safety of PH FDC SC at home was consistent with the established P + H safety profile, indicating that PH FDC SC at home is a viable option for continuing BC care during and beyond COVID-19.
- Ogivri (trastuzumab biosimilar) / Biocon, Viatris, Herceptin (trastuzumab) / Roche
A prospective real-world study to assess the effectiveness and safety of trastuzumab biosimilar in the adjuvant treatment of HER2-positive breast cancer: Preliminary safety results. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_3393;
P=N/A
Neoadjuvant therapy included the trastuzumab biosimilar administration (25%) and the dual anti-HER2 block (trastuzumab biosimilar + pertuzumab) (68.8%)... The nature and severity of AEs observed were consistent with the known safety profile of trastuzumab.
- Opdivo (nivolumab) / Ono Pharma, BMS
Nivolumab with chemotherapy as neoadjuvant treatment for inflammatory breast cancer. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_3392;
P2
Addition of nivolumab to neoadjuvant therapy was tolerable and safe and demonstrated anti-tumor activity in IBC with high pCR rate in this pilot study. This supports further investigation of the role of checkpoint inhibitors in treatment of IBC.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
The effect of breast radiotherapy parameters (XRT), chemotherapy regimens (CT) and dual anti-HER2 monoclonal antibodies (MoAb) on the development of cardiac dysfunction (CD) among patients with HER2-positive breast cancer from Saudi Arabia. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_3374;
Likewise, the dual anti-HER2 therapy with trastuzumab and pertuzumab and the number of trastuzumab cycles did not influence CD. It is reassuring to demonstrate the safety of these approaches in real-life clinical practice.
- Kadcyla (ado-trastuzumab emtansine) / Roche, Perjeta (pertuzumab) / Roche
Serum thymidine kinase 1 and its kinetics in HER2-positive breast cancer: Results from the Swedish phase II PREDIX HER2 trial. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_3373;
>a Adjusted for intervention arm, tumor subtype, and tumor size. b Linear trends across tertiles of TK1 were tested by modeling the median value in each quintile as a continuous variable in Logistic regression.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Real-life analysis of pathologic complete response with neoadjuvant trastuzumab plus taxane with or without pertuzumab therapy in HER2 positive locally-advanced breast cancer (HER2PATH Study). () - Apr 28, 2022 - Abstract #ASCO2022ASCO_3363;
P=N/A
Despite the patients at NCT-HP group mostly received docetaxel (75%), NCT-H group received weekly paclitaxel (59.4%) as taxane (p<0.001). Our analysis of this real world data shows higher rates of pCR than in clinical trials, also adding pertuzumab to NCT-H demonstrates higher pCR rates and EFS rates compared with NCT-H in patients with HER2+ LABC.
- pegylated liposomal doxorubicin / Generic mfg., cyclophosphamide / Generic mfg., albumin-bound paclitaxel / Generic mfg.
Neoadjuvant pegylated liposomal doxorubicin (PLD) plus cyclophosphamide followed by nab-paclitaxel (Nab-P) as primary chemotherapy continuously combined with dual HER2 blockage for HER2-positive breast cancer: A single-arm phase 2 trial (Brecan Trial). () - Apr 28, 2022 - Abstract #ASCO2022ASCO_3358;
The PldCHP---Nab-PHP regimen is a feasible and effective neoadjuvant therapy for early stage HER2-positive breast cancer, showing high pCR rate and acceptable cardiotoxicity. These results support a further random controlled trial testing for continuous dual anti-HER2 therapy combined with PLD in neoadjuvant or adjuvant therapy of HER2 positive breast cancer.
- Molecular subtype to predict pathologic complete response in HER2-positive breast cancer in the I-SPY2 trial. (Available On Demand; 282) - Apr 28, 2022 - Abstract #ASCO2022ASCO_3323;
P2
Molecular response predictive subtype classification provides insight on how to better target therapy. The HER2+/Luminal group had low pCR rates with dual HER2-blockade but may have higher pCR rate with the addition of an AKT inhibitor and identifies a subgroup of HER2+ tumors in need of novel approaches.
- Keytruda (pembrolizumab) / Merck (MSD)
Neoadjuvant HER2-targeted therapy +/- immunotherapy with pembrolizumab (neoHIP): An open-label randomized phase II trial. (Available On Demand; 386b) - Apr 28, 2022 - Abstract #ASCO2022ASCO_3321;
P2
Clinically, pembrolizumab (K)-mediated ICI plus HER2-directed therapy with trastuzumab (H) was safe and demonstrated modest activity in H-resistant HER2-positive (HER2+) metastatic breast cancer...Moreover, the synergy of H and K with paclitaxel (T) may overcome the need for dual HER2-blockade with H plus pertuzumab (P)...Secondary end points include pCR rate by ypT0ypN0 and ypT0/Tis, residual cancer burden index, event free survival, breast conserving surgery rate, safety and overall survival. Exploratory correlative studies will characterize potential immune biomarkers predictive of efficacy and/or toxicity.
- Kadcyla (ado-trastuzumab emtansine) / Roche, Perjeta (pertuzumab) / Roche
DECRESCENDO: De-escalation of adjuvant chemotherapy in patients with HER2+/HR-/node-negative early breast cancer who achieve pCR after neoadjuvant taxane and subcutaneous dual anti-HER2 blockade. (Available On Demand; 385a) - Apr 28, 2022 - Abstract #ASCO2022ASCO_3318;
P2
DECRESCENDO is a large, multicentric, single-arm, phase 2 de-escalation study evaluating the efficacy of neoadjuvant CT with paclitaxel 80mg/m2 weekly or docetaxel 75mg/m2 every 3 weeks (Q3W) with pertuzumab and trastuzumab (P+T) 600/600mg fixed-dose combination (FDC) for subcutaneous (SC) injection Q3W for patients with early HER2+, HR- (ER<1% and PR<1%) BC...Patients with RCB≥1 will receive adjuvant T-DM1 (preceded by anthracycline-based CT if RCB≥2)...The first patient was enrolled in January 2022. The trial is co-led by the Breast International Group (BIG) and Institut Jules Bordet.