Randomized Phase III Trial of Multimodality Therapy Versus Standard of Care Systemic Therapy in HER2 Positive (HER2+) De Novo (AJCC Stage IV) Oligometastatic Breast Cancer With Response to Initial Chemotherapy

This phase III trial evaluates the effect of adding locoregional therapy (surgery and radiation) and metastasis-directed stereotactic body radiation therapy (SBRT) to standard systemic therapy following standard HER2-targeted systemic therapy, compared to standard systemic therapy alone, in treating patients with HER2-positive stage IV breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or to a limited number of sites (oligometastatic). The usual approach for patients with (oligo)metastatic HER2-positive breast cancer is systemic drug treatment, which means medicines that travel through the whole body to treat both the breast and any areas where the cancer has spread. There are a number of approved HER2-targeted systemic therapy regimens available to patients. These typically include immunotherapy and/or chemotherapy. Immunotherapy drugs may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Unlike systemic therapy, locoregional therapies like surgery and radiation are focused treatments at the site of disease, delivered with the intent of sparing healthy tissues. Breast surgeries such as breast conserving therapy or total mastectomy are procedures in which the cancerous breast tissue (and healthy breast tissue in the case of total mastectomy) are surgically removed from the body. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Adding locoregional therapy, as well as metastasis-directed SBRT, to standard systemic therapy may help patients with (oligo)metastatic, HER2-positive stage IV breast cancer live longer overall or before their cancer progresses, and may help more patients achieve no evidence of disease, when compared to standard systemic therapy alone.

Start Date09 Mar 2027

Sponsor / Collaborator

SWOG

[+1]

NCT07772245

/ Not yet recruitingPhase 2IIT

Phase II Trial of Retifanlimab With Trastuzumab and Pertuzumab Combination in HER2-Addicted Breast Cancer

The goal of this Clinical Trial is to find out how well 3 medicines (retifanlimab, trastuzumab and pertuzumab) work at treating HER2-positive breast cancer in Male and female patients, 18 or older. The main question aims to determine the pathologic response rate [residual cancer burden (RCB)- 0] in the breast and lymph nodes after 6 cycles of retifanlimab, trastuzumab and pertuzumab in patients with HER2-addicted breast cancer. Participants will will have at least 6 cycles of the study drug, assuming the participant is responding to and tolerating the treatment well. Every cycle will last about 21 days.

Start Date31 Dec 2026

Sponsor / Collaborator

The Methodist Hospital Research Institute

NCT07679269

/ Not yet recruitingPhase 2

An Open Label, Multi-center Alpelisib Roll-over Study to Assess Long-term Safety in Participants Who Have Completed a Novartis Sponsored Alpelisib (BYL719) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Alpelisib.

The purpose of this study is to provide post-trial access to alpelisib and to assess its long-term safety when administered as a single agent or in combination with other drugs. This study is intended for participants who are currently receiving alpelisib in a Novartis-sponsored clinical trial (parent study) and, in the Investigator's judgment, would benefit from continued treatment with alpelisib.

Start Date15 Dec 2026

Sponsor / Collaborator

Novartis Pharmaceuticals Australia Pty Ltd.

100 Clinical Results associated with Trastuzumab

100 Translational Medicine associated with Trastuzumab

100 Patents (Medical) associated with Trastuzumab

12,995

Literatures (Medical) associated with Trastuzumab

01 Mar 2027·CLINICA CHIMICA ACTA

Cardiac troponin autoantibodies and cancer therapy-related cardiac dysfunction in breast cancer patients receiving anthracycline treatment: secondary analysis of the PRADA study

Article

Author: Vinje-Jakobsen, Victoria ; Wittfooth, Saara ; Gulati, Geeta ; Heck, Siri L ; Omland, Torbjørn ; Junes, Helea

BACKGROUND:

Cardiac troponins (cTn) are biomarkers for cardiac injury and used for detection and monitoring of cancer therapy-related cardiac dysfunction (CTRCD). However, cTn-specific autoantibodies (cTnAAb) can interfere with cTn measurements. The purpose of this study was to investigate the prevalence of cTnAAbs and whether cTnAAbs associate with the development of CTRCD in breast cancer patients receiving anthracyclines such as epirubicin.

METHODS:

This study included 119 patients from the PRADA trial, where study drugs metoprolol and candesartan were given concomitantly with 5-fluorouracil, epirubicin and cyclophosphamide therapy with or without trastuzumab and/or radiation. Blood samples obtained at baseline, after 1st cycle and at completion of epirubicin therapy, after possible additional treatment and at 2-year follow-up were analysed for cTnAAbs using an investigational immunoassay.

RESULTS:

We detected cTnAAbs in 6 patients (5%), out of whom 3 (50%) developed mild CTRCD, whereas 68 out of 113 (60%) cTnAAb-negative patients developed mild CTRCD (p = 1.0). High-sensitivity cTnI (Abbott) concentrations were higher in cTnAAb-positive than negative patients at baseline (median [95% CI] 2.1 [1.5, 6.1] vs. 0.8 [0.8, 1.2] ng/L, p < 0.001) and after the first cycle of anthracyclines (2.3 [1.1, 7.1] vs. 1.2 [0.8, 1.3] ng/L, p < 0.05) but not after completion of anthracycline therapy.

CONCLUSIONS:

The prevalence of cTnAAbs was low in this breast cancer cohort. The presence of cTnAAbs in circulation was associated with slightly higher initial concentrations of cTnI. No associations between the production of cTnAAbs and the development of CTRCD were observed in this study.

01 Feb 2027·BIOELECTROCHEMISTRY

Super-antifouling electrochemical biosensor based on a biomimetic gemini zwitterionic interface for sensitive detection of therapeutic antibodies

Article

Author: Qu, Jia-Huan ; Zhao, Zheng ; Han, Hai ; Li, Haidong ; Yu, Wanqing ; Chen, Zhiwei ; Jiang, Zhengjin ; Hai, MingFang ; Wang, Qiqin

Biofouling, arising from the nonspecific adsorption of proteins, cells, and other biomolecules, remains a major challenge that compromises the stability and reliability of diagnostic and therapeutic platforms. To address this issue, a super-antifouling electrochemical aptasensor was developed by integrating a biomimetic "gemini" zwitterionic monomer (BSMMP) with polydopamine (PDA). The covalent assembly of BSMMP and PDA forms a multi-site anchoring layer that enables the stable functionalization of the affinity aptamer GC20. Owing to its dense hydration shell, the PDA-BSMMP hybrid interface acts as a physical barrier against nonspecific adsorption, maintaining electron-transfer stability in undiluted human serum. Differential pulse voltammetry confirmed that this interface markedly reduced biofouling-induced signal loss, limiting attenuation to less than 15%, nearly fourfold lower than that of the unmodified surface. The platform achieved a low limit of detection of 0.97 ng/mL, a broad linear range from 1 ng/mL to 100 μg/mL, and high selectivity for trastuzumab in a label-free format without secondary antibodies or additional signal amplification. Finally, this platform successfully quantified trastuzumab in serum from breast cancer patients, with results consistent with commercial ELISA kits. Overall, this super-antifouling aptasensor offers great potential for therapeutic drug monitoring, advancing zwitterionic interface-based biosensing strategies for point-of-care diagnostics.

01 Jan 2027·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Development and application of antibody framework region-targeted cross-linking mass spectrometry for epitope screening within patient-derived immune complexes

Article

Author: Ohyama, Kaname ; Aibara, Nozomi ; Nakamura, Minoru ; Matsugi, Yuya ; Kutsuna, Yuki Jimbayashi ; Hamasaki, Maya ; Kawakami, Atsushi ; Yamazawa, Ryuji ; Nakashima, Mikiro

Identification of antibody-binding epitopes on antigens is essential for understanding the pathogenic roles of immune complexes (ICs) in autoimmune diseases and for the development of diagnostics and therapeutics. However, methods for direct epitope characterization of IC-antigens formed in vivo remain limited. Here, we investigated antibody framework region (FR)-targeted cross-linking mass spectrometry (XL-MS) as an approach to identify epitopes in patient-derived ICs. Four IC models with known epitopes (tumor necrosis factor alpha-adalimumab, tumor necrosis factor alpha-infliximab, human epidermal growth factor receptor 2-pertuzumab, and human epidermal growth factor receptor 2-trastuzumab) were analyzed using three cross-linkers of different lengths: bis(sulfosuccinimidyl) suberate (BS3), bis(sulfosuccinimidyl) glutarate (BS2G), and 1,1'-carbonyldiimidazole (CDI). BS3 preferentially generated antigen-FR cross-links, whereas CDI predominantly produced antigen-complementarity-determining region cross-links. Several cross-linked peptides contained antigen sequences overlapping previously reported epitopes, supporting the validity of this approach for epitope mapping. As a proof-of-concept clinical application, serum samples from patients with primary biliary cholangitis were analyzed using a targeted database containing four disease-associated autoantigens (PDC-E2, BCOADC-E2, OGDC-E2, and E3BP). Two candidate epitope peptides were identified. One corresponded to a known immunodominant epitope, whereas the other represented a novel candidate site supported by computational epitope prediction analysis. These findings demonstrate that FR-targeted XL-MS provides a strategy for identifying epitopes within patient-derived IC-antigens through the use of conserved antibody FRs. This approach may contribute to understanding antigen recognition mechanisms in autoimmune diseases and support the discovery of disease-relevant therapeutic targets.

1,149

News (Medical) associated with Trastuzumab

26 Oct 2026

·firstwordpharma.com

'Modest' benefit scuppers BioNTech's breast cancer ambitions for trastuzumab pamirtecan

BioNTech and DualityBiologics said Monday that a Phase III study of trastuzumab pamirtecan (BNT323/DB-1303) in chemotherapy-naïve patients with HR+/HER2-low metastatic breast cancer who have progressed on endocrine therapy met its primary endpoint of progression-free survival (PFS). However, the overall results from the DYNASTY-Breast02 trial suggest that the HER2-targeting antibody-drug conjugate (ADC) will not be progressing in this setting.While the companies noted that trastuzumab pamirtecan demonstrated a statistically significant improvement in PFS over investigator's choice of chemotherapy, they described the benefit as "modest." They also said that there was a higher rate of interstitial lung disease (ILD) than seen in prior studies of trastuzumab pamirtecan — although most cases were grade 1 and 2 — as well as "severe and fatal events…in a small proportion of patients."The global trial enrolled patients with HR+/HER2-low metastatic breast cancer whose disease has progressed on at least two lines of prior hormone therapy or within six months of first line hormone therapy plus CDK 4/6 inhibitor in the metastatic setting. A total of 541 participants with HER2-low expression were randomised to receive either trastuzumab pamirtecan or investigator's choice of single-agent chemotherapy, comprising capecitabine, paclitaxel or nab-paclitaxel. Along with the primary endpoint of PFS, DYNASTY-Breast02 is measuring overall survival (OS) as a secondary goal. BioNTech and DualityBio said Monday that data for OS were not yet mature at this interim analysis.Given the outcome, the companies concluded that trastuzumab pamirtecan's "potential benefit to patients would be limited in the context of the HR+/HER2-low metastatic breast cancer treatment landscape." The partners plan to review the data before determining next steps.AstraZeneca and Daiichi Sankyo's HER2-targeting ADC Enhertu (trastuzumab deruxtecan) is authorised in both the US and EU for the treatment of adults with unresectable or metastatic HR+, HER2-low or HER2-ultralow breast cancer that has progressed on one or more endocrine therapies in the metastatic setting. The approvals are based on the Phase III DESTINY-Breast06 study, in which patients with HER2-low tumours had a 36% lower chance of their cancer growing or spreading compared with chemotherapy.Outside of DYNASTY-Breast02, BioNTech and DualityBio are investigating trastuzumab pamirtecan in the Phase III Fern-EC-01 study for previously-treated patients with HER2-expressing advanced recurrent endometrial cancer.

Phase 3Clinical ResultDrug ApprovalADC

26 Oct 2026

·www.biopharmadive.com

BioNTech, DualityBio say ADC had ‘modest’ benefit in breast cancer study

An antibody-drug conjugate from BioNTech and DualityBio met its main goal in a Phase 3 study in breast cancer, but may only have a limited impact in people with the condition, the companies said Monday.The treatment, known as trastuzumab pamirtecan, successfully delayed tumor progression in a trial of people whose breast tumors express low, but still detectable levels of the HER2 protein. The improvement on that measure was modest, though, and treatment was also associated with higher rates of interstitial lung disease a potentially deadly kind of lung inflammation than the companies had seen in earlier testing.The partners also revealed that severe and fatal events were observed in a small proportion of patients. They revealed, too, that the trial hadnt been run long enough to detect a clear survival benefit. The combined findings suggest that the potential benefit to patients would be limited given the current treatment landscape for HER2-low metastatic breast cancer. The companies will discuss the data and determine next steps, they said.Trastuzumab pamirtecan is involved in two other ongoing trials. One is a late-stage study in HER2-positive endometrial cancer. The other is an early-stage study in advanced, metastatic solid tumors.BioNTech obtained trastuzumab pamirtecan through a 2023 licensing deal with DualityBio that marked BioNTechs first foray into antibody-drug conjugates, or ADCs. Potentially worth more than $1.6 billion overall, that pact was part of a broader effort by BioNTech to pursue oncology research and rely on more than its core messenger RNA technology.That strategy has produced mixed results so far. Prior to Mondays announcement, the company had reported two otherclinical setbacks.ADCs have become a mainstay of cancer care and, in some tumor types, have been able to supplant traditional chemotherapy. One of those examples is in breast cancer, where AstraZeneca and Daiichi Sankyos Enhertu is deeply entrenched across multiple treatment lines. Enhertu gained the first-ever approval of a therapeutic for HER2-low disease in 2022 and followed that up with a clearance in tumors with ultralow HER2 expression three years later.Like Enhertu, trastuzumab pamirtecan is an ADC aimed at the HER2 protein. '

License out/inPhase 3ADCClinical ResultDrug Approval

26 Oct 2026

·www.biospace.com

BioNTech and DualityBio Announce Topline Results of the DYNASTY-Breast02 Global Phase 3 Clinical Trial Evaluating Trastuzumab Pamirtecan in HR+/HER2-low Metastatic Breast Cancer

MAINZ, Germany and SHANGHAI, China, October 26, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and DualityBiologics (Suzhou) Co., Ltd. (“DualityBio”, HKEX: 9606.HK) announced today that the DYNASTY-Breast02 global Phase 3 clinical trial ( NCT06018337 ) met its primary endpoint demonstrating a statistically significant, yet modest improvement in progression-free survival (“PFS”) with trastuzumab pamirtecan (BNT323/DB-1303) compared to investigator’s choice of chemotherapy in chemotherapy-naïve patients with HR+/HER2-low metastatic breast cancer who have progressed on endocrine therapy. At this interim analysis for the secondary endpoint of overall survival (“OS”), data were not mature. A higher rate of interstitial lung disease (“ILD”) was reported in this trial compared to prior trials with trastuzumab pamirtecan, with most cases being Grade 1 and 2. Severe and fatal events were reported in a small proportion of patients (Grade 3-5). Otherwise, the overall safety pro consistent with prior clinical trials and no new safety signals were observed. The available efficacy and safety data, as of this data cut-off date, suggest that the potential benefit to patients would be limited in the context of the HR+/HER2-low metastatic breast cancer treatment landscape. The companies will discuss the data and determine next steps. BioNTech and DualityBio are developing trastuzumab pamirtecan in three ongoing clinical trials, including two global Phase 3 clinical trials, in HR+/HER2-low metastatic breast cancer ( NCT06018337 ) and in HER2-expressing recurrent e ndometrial cancer ( NCT06340568 ), as well as in a global Phase 1/2 clinical trial ( NCT05150691 ) in patients with advanced/metastatic solid tumors. About DYNASTY-Breast02 DYNASTY-Breast02 is a global Phase 3 randomized, multi-center, open-label clinical trial in patients living with HR+/HER2-low metastatic breast cancer whose disease has progressed on at least two lines of prior hormone therapy or within six months of first line hormone therapy plus cyclin-dependent kinase (CDK) 4/6 inhibitor in the metastatic setting. The primary endpoint of the clinical trial is PFS with a key secondary endpoint of OS. In the trial, 541 patients with HER2-low expression (IHC 2+/ISH- and IHC 1+) were randomized 1:1 to receive either trastuzumab pamirtecan or investigator's choice single-agent chemotherapy (capecitabine, paclitaxel or nab-paclitaxel). About trastuzumab pamirtecan Trastuzumab pamirtecan (BNT323/DB-1303) is a third-generation topoisomerase-1 inhibitor-based ADC targeting HER2 being developed by BioNTech and Duality Biologics. Trastuzumab pamirtecan was built from DualityBio’s proprietary Duality Immune Toxin Antibody Conjugates (“DITAC”) platform. HER2 is a surface-expressed protein on solid tumors and has been linked to the aggressive growth and spread of cancer cells. Trastuzumab pamirtecan is being evaluated in an ongoing Phase 1/2 trial ( NCT05150691 ) in patients with advanced/metastatic solid tumors, in Fern-EC-01, a randomized Phase 3 clinical trial ( NCT06340568 ) evaluating trastuzumab pamirtecan compared with investigator's choice of single agent chemotherapy in previously treated patients with HER2-expressing advanced recurrent endometrial cancer, and in DYNASTY-Breast02, a randomized Phase 3 clinical trial ( NCT06018337 ) in chemotherapy-naïve patients with HR+/HER2-low metastatic breast cancer who have progressed on endocrine therapy. About BioNTech BioNTech is a global next generation biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases. In oncology, BioNTech is committed to transforming how cancer is treated. Its ambition is to develop innovative medicines with pan-tumor or synergistic potential to address cancer from multiple angles and across the full continuum of the disease from early- to late-stage. Its growing late-stage oncology pipeline comprises complementary treatment approaches spanning immunomodulators, antibody-drug conjugates, and mRNA cancer immunotherapies. BioNTech has partnered with multiple global and specialized pharmaceutical collaborators leveraging complementary expertise and resources to accelerate innovation and drive progress, including Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, and Pfizer. For more information, please visit . BioNTech Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the collaboration between BioNTech and DualityBio to jointly clinically develop antibody-drug conjugates (ADCs) including trastuzumab pamirtecan (BNT323/DB-1303); the initiation, timing, progress, and results of BioNTech’s research and development programs, including data from the DYNASTY-Breast02 Phase 3 clinical trial (NCT06018337) evaluating trastuzumab pamirtecan in HR+/HER2-low metastatic breast cancer; the expected timing of initiation, enrollment, and completion of trials and related preparatory work and the availability of results; and discussions with regulatory agencies. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events and are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control, and which could cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with clinical data, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the impact of tariffs and escalations in trade policy; competition related to BioNTech’s product candidates; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; BioNTech’s ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech’s third-party collaborators to continue research and development activities relating to BioNTech’s development candidates and investigational medicines; unforeseen safety issues and potential claims that are alleged to arise from the use of products and product candidates developed or manufactured by BioNTech; BioNTech’s and its collaborators’ ability to commercialize and market its product candidates, if approved; BioNTech’s ability to manage its development and related expenses; regulatory and political developments in the United States and other countries; BioNTech’s ability to effectively scale its production capabilities and manufacture its products and product candidates; and other factors not known to BioNTech at this time. You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the period ended June 30, 2026, and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. About DualityBio DualityBio is a clinical-stage innovative biopharmaceutical company dedicated to developing next-generation antibody-drug conjugates (ADCs) for patients with cancer and autoimmune diseases. The Company has successfully built multiple next-generation ADC technology platforms with global intellectual property rights. Grounded in a deep understanding of disease biology, DualityBio has established a robust clinical-stage ADC pipeline and is conducting multiple global, multicenter clinical trials across nearly 20 countries, with over 3,500 patients enrolled to date. Furthermore, DualityBio has entered into several out-licensing collaborations with global pharmaceutical companies and leading innovative biotech firms. Serving as a global engine for ADC innovation, DualityBio continues to develop next-generation novel ADCs, including bispecific ADCs, ADCs with novel payloads, and autoimmune ADCs. For more information, please visit . CONTACTS BioNTech Media Relations Jasmina Alatovic Media@biontech.de Investor Relations Douglas Maffei, PhD Investors@biontech.de DualityBio Media Relations PR@dualitybiologics.com Investor Relations IR@dualitybiologics.com

Phase 3ADCImmunotherapyClinical Result

100 Deals associated with Trastuzumab

External Link

KEGG	Wiki	ATC	Drug Bank
D03257	Trastuzumab	L01FD01	DB00072

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HER2 Positive Colorectal Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	28 Mar 2022
HER2 positive salivary gland cancer	Japan	Chugai Pharmaceutical Co., Ltd.	25 Nov 2021
HER2-positive gastric cancer	Japan	Chugai Pharmaceutical Co., Ltd.	10 Mar 2011
Stomach Cancer	United States	Genentech, Inc.	20 Oct 2010
Breast Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	04 Apr 2001
Early Stage Breast Carcinoma	European Union	Roche Registration GmbH	28 Aug 2000
Early Stage Breast Carcinoma	Iceland	Roche Registration GmbH	28 Aug 2000
Early Stage Breast Carcinoma	Liechtenstein	Roche Registration GmbH	28 Aug 2000
Early Stage Breast Carcinoma	Norway	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	European Union	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	Iceland	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	Liechtenstein	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	Norway	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	European Union	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	Iceland	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	Liechtenstein	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	Norway	Roche Registration GmbH	28 Aug 2000
Hormone receptor positive breast cancer	European Union	Roche Registration GmbH	28 Aug 2000
Hormone receptor positive breast cancer	Iceland	Roche Registration GmbH	28 Aug 2000
Hormone receptor positive breast cancer	Liechtenstein	Roche Registration GmbH	28 Aug 2000

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bladder Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Colorectal Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Gallbladder Neoplasms	Phase 3	United Kingdom	-	07 Mar 2023
Hematologic Neoplasms	Phase 3	United Kingdom	-	07 Mar 2023
Lung Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Ovarian Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Pancreatic Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Prostatic Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Salivary Gland Neoplasms	Phase 3	United Kingdom	-	07 Mar 2023
Skin Neoplasms	Phase 3	United Kingdom	-	07 Mar 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO2026	Not Applicable	HER2 Positive Breast Cancer Neoadjuvant HER2-positive	74	Subcutaneous dual HER2 blockade	iexmhplrkk(ukqozxznxf) = zlfhahtnoe vxylaejvbj (eztkaioioa )	Positive	23 Oct 2026
				Intravenous dual HER2 blockade	iexmhplrkk(ukqozxznxf) = nhnejhpldy vxylaejvbj (eztkaioioa )
ESMO2026	Not Applicable	Neoplasms	15	targeted therapies (e.g., trastuzumab, cetuximab)	cemezifbid(uygfyjnvrm) = vdjnneucsg pfrnplnsqp (jogbkpitoe, 23 - 110)	Positive	23 Oct 2026
JPRN-UMIN000034222 (Ni-HIGH, ESMO2026)	Phase 1	HER2 Positive Gastroesophageal Adenocarcinoma First line HER2-positive \| PD-L1-positive	27	Nivolumab, trastuzumab, and chemotherapy	pcyevendao(ipfxbtkbgd) = azoehrnjcr nqrkzcpmgr (aeprzdjccg ) View more	Negative	23 Oct 2026
				Nivolumab, trastuzumab, and chemotherapy (EV-derived Cystatin C ≥ median)	pcyevendao(ipfxbtkbgd) = mrsnjfvljm nqrkzcpmgr (aeprzdjccg ) View more
NCT05885776 (PHEDRA, ESMO2026)	Phase 2	HER2 Positive Breast Cancer Neoadjuvant HER2 positive \| HR positive	48	Pyrotinib + Trastuzumab + AI	hrszhxawdt(fbyuybmpfw) = qglijubntm oqfyefmxqj (iyuqqzeiva ) View more	Positive	23 Oct 2026
ESMO2026	Phase 2	HER2-positive gastric cancer HER2-positive \| CLDN18.2-positive	46	S-1+oxaliplatin+trastuzumab	iudcapfzar(pifrnwgbej) = nnfsuqhnsd rrtdhxkeyz (enyoofdwfq ) View more	Positive	23 Oct 2026
				S-1+oxaliplatin+trastuzumab (HER2+/CLDN18.2+)	znpfjnwxxs(yttzzzagxe) = gowceremgl depvelmwlp (ysreszcbxe ) View more
NCT04588545 (INSPIRE-LM, ESMO2026)	Phase 2	Metastatic Malignant Neoplasm to the Leptomeninges HER2+	30	Radiation therapy + IT trastuzumab + pertuzumab	xnayigdmrf(avhelchsoj) = tbrvpjeups uiuskepubz (sukzyukeip ) View more	Positive	23 Oct 2026
ESMO2026	Not Applicable	HER2 Positive Breast Cancer Neoadjuvant HER2-positive	78	Trastuzumab and Pertuzumab	fbgmywubhu(asrogibzbr) = aukvpxkqpq xijhpvfryb (zctedwluhu )	Positive	23 Oct 2026
ESMO2026	Not Applicable	HER2-negative breast cancer HER2 overexpression	195	Trastuzumab	afxxqtmbul(smkruvahhn) = wtsoexftiw dehtzlgjhh (urwmkqjyam ) View more	Positive	23 Oct 2026
ESMO2026	Not Applicable	Early Stage Breast Carcinoma HR+ \| HER2+ \| HR− ... View more	15,673	Chemotherapy	bizhxnenxr(vkvydiaezn) = vkmhgcgugh ogvdulpilj (rcpozplndp ) View more	Positive	23 Oct 2026
				Targeted therapy + Extended endocrine therapy	bizhxnenxr(vkvydiaezn) = dsrwklgmim ogvdulpilj (rcpozplndp ) View more
ESMO2026	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast First line HER2-positive	697	Trastuzumab and taxane	zljzhadfdj(rboqsvoebw) = zppurmceen dbyrkzuncn (vtbbeahsjn ) View more	Positive	23 Oct 2026
				Trastuzumab, taxane, and pertuzumab (THP)	zljzhadfdj(rboqsvoebw) = rodnislbnc dbyrkzuncn (vtbbeahsjn ) View more

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