Metastatic breast cancer with human epidermal growth factor receptor 2 positivity (HER2+). Malignant neoplasm of breast
Conditions
Interventions
Intervention 1: Intervention group: Tederox (manufactured by Nano Daru Pajuhan Pardis Company)The participant allocation ratio is set at 2:1, meaning that for every two patients receiving the drug Ted
Sponsors
Nano Daru Pajuhan Pardis company
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age = 18 years Ability to comply with the visit schedule and follow-up procedures throughout the study period Willingness and ability to undergo regular visits and imaging assessments according to the study timeline and to cooperate with the study team Provision of signed written informed consent Confirmed diagnosis of advanced or metastatic HER2-positive breast cancer, defined by immunohistochemistry (IHC 3+) or IHC 2+ with confirmation by FISH or CISH. Confirmed recurrence, disease progression, or lack of response following first-line treatment (adjuvant or neoadjuvant therapy with taxane + trastuzumab) within less than 6 months. Suitable clinical condition for enrollment, including: Echocardiography showing left ventricular ejection fraction (EF) > 50% at screening. Presence of at least one measurable tumor site according to RECIST 1.1 criteria .Performance status of 0–1 based on ECOG criteria . Laboratory values within acceptable range at screening (no more than 4 weeks prior to treatment initiation):Hemoglobin = 9 g/dL Leukocytes = 3.0 × 10?/L Neutrophils = 1.5 × 10?/L Platelets = 100 × 10?/L Total bilirubin = 1.5 × ULN (in absence of liver metastasis); for patients with Gilbert’s syndrome or liver metastasis, total bilirubin = 3 × ULN AST = 5 × ULN ALT = 5 × ULN Estimated creatinine clearance (eClCr) = 30 mL/min
Exclusion criteria
Exclusion criteria: Prior treatment with trastuzumab deruxtecan Known hypersensitivity to any component of the study drugs History of any malignancy within the past 5 years, except for cervical carcinoma in situ, basal cell carcinoma (BCC), or squamous cell carcinoma (SCC) of the skin Receipt of systemic anti-cancer therapy under any of the following conditions: Antibody-based immunotherapy, retinoid therapy, or hormonal therapy within 3 weeks prior to randomization Antibody-based anti-cancer therapy within 4 weeks prior to randomization Nitrosoureas or mitomycin C within 6 weeks prior to randomization Small molecule targeted therapy within 2 weeks or 5 half-lives prior to randomization (whichever is longer) Participation in a therapeutic clinical trial within 3 weeks prior to randomization or current involvement in other investigational procedures Major surgery within 4 weeks prior to randomization Pregnancy or breastfeeding Presence of any of the following conditions: a. Nodular regenerative hyperplasia of the liver.b. Diffuse interstitial lung disease, pneumonitis.c. Dyspnea at rest due to progression of the malignant neoplasm or comorbidity.d. Serious heart rhythm disturbances requiring drug therapy.e. Symptomatic congestive heart failure/uncontrolled hypertension. History of myocardial infarction (MI) or unstable angina within 6 months prior to randomization, or troponin levels consistent with MI within 28 days prior to randomization QT interval prolongation > 470 ms (in females) History of heart failure with EF 2 or history of arrhythmia requiring treatment) Active infection or history of chronic infection within 28 days prior to randomization History of interstitial lung disease or pneumonitis requiring corticosteroid treatment Severe clinical pulmonary impairment due to underlying lung diseases, including: Pulmonary embolism within 3 months of study enrollment Severe asthma, severe COPD, restrictive lung disease, pleural effusion Autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (e.g., rheumatoid arthritis, Sjögren’s syndrome, sarcoidosis)Prior pneumonectomy Spinal cord involvement or active CNS metastases defined as untreated, symptomatic, or requiring corticosteroids or anticonvulsants for symptom control Patients with asymptomatic brain metastases may participate Patients with treated brain metastases who are symptom-free and no longer require corticosteroids or anticonvulsants may participate A minimum of 2 weeks must have passed since completion of brain radiotherapy to be eligible Patients with bone-only metastases Active infection with HBV, HCV, or HIV Any investigator judgment indicating incompatibility with the study protocol or potential risk to the participant’s health due to study participation History of breast cancer surgery or radiotherapy within 3 months prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR (Objective Response Rate): This variable represents the percentage of participants in the study who achieve a complete response (CR) or partial response (PR) according to the RECIST 1.1 criteria. Timepoint: Week 24 and Week 48. Method of measurement: Assessment of tumor size changes according to RECIST 1.1 criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| TTR (Time to Tumor Response), CBR (Clinical Benefit Rate), PFS (Progression-Free Survival), CR (Complete Response), PR (Partial Response)Comparison of the best change in the sum of tumor diameters (relative to baseline size),Comparison of the incidence and severity of adverse events (AEs) between the two groups. Timepoint: TTR (Time to Tumor Response): Measured from randomization to the time of response to treatment, according to RECIST 1.1 criteria.CBR (Clinical Benefit Rate): Assessed at week 24 and week 48.PFS (Progression-Free Survival): Assessed at week 48.CR (Complete Response) and PR (Partial Response): Evaluated at weeks 24 and 48.Best Change in Sum of Tumor Diameters: Assessed at weeks 24 and 48.Adverse Events (AEs): Recorded throughout the study. Method of measurement: TTR (Time to Tumor Response): This variable represents the duration from randomization and study entry until the time of response to treatment according to RECIST 1.1 criteria.CBR (Clinical Benefit Rate): This variable is defined as the sum of CR (Complete Response), PR (Partial Response), and SD (Stable Disease), compared between the two groups at week 24, and also compared at week 48 in the Tederox group and in patients who received Enhertu until week 24 and subsequently switched to Tederox.PFS (Progression-Free Survival): Evaluation of PFS at week 48 in the Tederox group.CR (Complete Response): Evaluation and comparison of CR at week 24 between the two groups, and at week 48 in the Tederox group and in patients who received Enhertu until week 24 and subsequently switched to Tedrox.PR (Partial Response): Evaluation and comparison of PR at week 24 between the two groups, and at week 48 in the Tederox group and in patients who received Enhertu until week 24 and subsequently switched to Tederox.Best Tumor Size Change: Comparison of the best percentage change in the sum of tumor diameters (relative to baseline) at week 24 between the two groups, and at week 48 in the Tederox group and in patie | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Morvarid Zarifyeganeh
Nano Daru Pajuhan Pardis company
Outcome results
None listed