A multicenter, open-label, single-arm, phase II trial exploring the maintenance of trastuzumab and pertuzumab following trastuzumab deruxtecan as induction treatment for HER2-positive unresectable locally recurrent or metastatic breast cancer patients.
- Conditions
- HER2-positive unresectable locally recurrent or metastatic breast cancer (MBC).Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-507306-13-00
- Lead Sponsor
- Medica Scientia Innovation Research S.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 132
Patient must be capable to understand the purpose of the study and have signed written informed consent form (ICF) prior to beginning specific protocol procedures., No prior chemotherapy and/or HER2-targeted therapy for advanced disease (one prior line of endocrine therapy is allowed for MBC)., Patients may have received adjuvant or neoadjuvant chemotherapy and/or HER2-targeted therapy before study treatment initiation, with a DFI from completion of the systemic treatment (excluding hormonal therapy) to metastatic diagnosis of at least 12 months., Patients with adequate bone marrow and organ function: Hematological (without platelet, red blood cell transfusion, and/or granulocyte colony-stimulating factor support within 7 days before first study treatment dose): White blood cell (WBC) count > 3.0 x 109/L, absolute neutrophil count (ANC) = 1.5 x 109/L, platelet count = 100.0 x109/L, and hemoglobin = 9.0 g/dL., Patients with adequate bone marrow and organ function: Hepatic: Serum albumin = 2.5 g/dL; total bilirubin = 1.5 times the upper limit of normal (x ULN) (= 3 x ULN in patients with known history of Gilbert’s disease); alkaline phosphatase (ALP) = 2.5 x ULN (= 5 × ULN in patients with liver and/or bone metastases); aspartate transaminase (AST) and alanine transaminase (ALT) = 1.5 x ULN (= 3 x ULN in patients with liver metastases)., Patients with adequate bone marrow and organ function: Renal: Creatinine clearance = 50 mL/min as determined by Cockcroft Gault (using actual body weight)., Patients with adequate bone marrow and organ function: Coagulation: International normalized ratio or prothrombin time and either partial thromboplastin or activated partial thromboplastin time = 1.5 × ULN., Resolution of all acute toxic effects of prior anticancer therapy to grade = 1 as determined by the US National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v.5.0) (except for alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion)., Women of childbearing potential who are sexually active with a non-sterilized male partner must have a negative serum pregnancy test within 14 days before study treatment initiation. In addition, they must agree to use one highly effective method of birth control from the time of screening until 7 months after the last dose of study treatments. Female patients must refrain from egg cell donation and breastfeeding during this same period., Male participants who are sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable method of contraception from the time of screening until 4 months after the last dose of T-DXd or 7 months after the last dose of PHESGO to prevent pregnancy. Male participants must not donate or bank sperm during this same period., Patient must be accessible for treatment and follow-up., Female or male patients = 18 years of age at the time of signing ICF., ECOG performance status of 0-1., Minimum life expectancy of = 12 weeks at screening., Evidence of HER2-overexpressing tumor status confirmed by MEDSIR’s designated central lab., Patients must have known estrogen receptor (ER) and progesterone receptor (PgR) status locally determined prior to study entry., Unresectable locally recurrent or metastatic disease documented by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent., Eval
Current participation in another therapeutic clinical trial, except other translational studies., Has an active cardiac disease or a history of cardiac dysfunction or severe conduction abnormalities including, but not confined, to any of the following: Poorly controlled hypertension (i.e., systolic blood pressure = 180 mmHg or diastolic blood pressure = 100 mmHg)., Has an active cardiac disease or a history of cardiac dysfunction or severe conduction abnormalities including, but not confined, to any of the following: Symptomatic pericarditis., Has an active cardiac disease or a history of cardiac dysfunction or severe conduction abnormalities including, but not confined, to any of the following: Left ventricular ejection fraction (LVEF) < 55% as determined by multi-gated acquisition (MUGA) scan or echocardiogram (ECHO)., Has an active cardiac disease or a history of cardiac dysfunction or severe conduction abnormalities including, but not confined, to any of the following: History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, or ventricular tachycardia), which is symptomatic or requires treatment (NCI-CTCAE grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, asymptomatic sustained ventricular tachycardia, or higher-grade atrioventricular [AV]-block, such as second-degree AV-block Type 2 [Mobitz 2] or third-degree AV-block). Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers will be permitted to enroll., Has an active cardiac disease or a history of cardiac dysfunction or severe conduction abnormalities including, but not confined, to any of the following: QT Interval Corrected by Fridericia’s formula (QTcF) prolongation to > 470 ms (females) or > 450 ms (males) based on average of the screening triplicate 12-lead ECG., Has an active cardiac disease or a history of cardiac dysfunction or severe conduction abnormalities including, but not confined, to any of the following: History of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and cause Torsades de Pointes., Has an active cardiac disease or a history of cardiac dysfunction or severe conduction abnormalities including, but not confined, to any of the following: Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives., Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within three months of the study enrolment, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, pleural effusion, post COVID-19 pulmonary fibrosis, etc.), and any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy., Has a history of non-infectious interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening., Pregnant or lactating women or patients not willing to apply highly effective contraception as defined in the protocol., Treatment with approved or investigational cancer therapy within 14 days prior
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method