2025-521798-15-00招募中3 期
Premedication with dexamethasone for preventing interstitial lung disease in patients with breast cancer treated with trastuzumab deruxtecan
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 244
- 试验地点
- 23
- 主要终点
- Cumulative incidence of patients who experience an ILD > G1 on high-resolution thorax CT scan during the treatment with T-DXd at 12 months from randomization by local Investigator’s judgement according to CTCAE, version 6.0. Discontinuation of T-DXd treatment for any reason other than ILD >G1 will be considered as a competing event.
研究概览
简要总结
The primary objective of the study is to assess the efficacy of dexamethasone premedication in reducing the occurrence of ILD >G1 in breast cancer patients receiving T-DXd treatment.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Provision of signed, written and dated study informed consent, data protection informed consent and any locally required
- •Women or men aged ≥18 years (or the minimum age of consent in accordance with the local law), at the time of informed consent signature
- •Histologically or cytologically confirmed metastatic breast cancer for which T-DXd treatment is approved and available at the participating center.
- •Diagnosis of metastatic breast cancer candidate to start a treatment with T-DXd in the subsequent settings: a. HR-positive with expression of HER2 (low or ultralow) ≤ 2 lines of chemotherapy in advanced disease b. HR-negative with expression of HER2-low ≤ 2 lines of chemotherapy in advanced disease c. HER2-positive independently from HR-positivity ≤ 3 lines of treatment in advanced disease
- •ECOG performance status of 0 or
- •Adequate bone marrow as defined by the following laboratory values: a. ANC ≥1.5 × 109 /L b. Platelets ≥100 × 109 /L c. Hemoglobin ≥9.0 g/dL
- •Adequate hepatic function: Serum albumin ≥ 2.5 g/dL; total bilirubin ≤ 1.5 times upper limit of normal (ULN) (≤ 3 in patients with liver metastases or know history of Gilbert’s disease); alkaline phosphatase (ALP) ≤ 2.5 times ULN; aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 times ULN (≤ 5 in patients with liver metastases); international normalized ratio (INR) < 1.
- •Adequate washout before randomization, including ≥4 weeks from major surgery or chest radiotherapy (≥2 weeks for non-chest stereotactic radiotherapy)
- •Patient willing and able to comply with the protocol procedures for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up.
排除标准
- •Patients with uncontrolled diabetes mellitus both type 1 and type 2 (HbA1c > 8.5%).
- •Inability to take oral medications, refractory or chronic nausea, gastrointestinal conditions (including significant gastric or bowel resection), history of malabsorption syndrome, or any other uncontrolled gastrointestinal condition that impacts the absorption of the study drug.
- •Palliative limited-field radiotherapy: <2 weeks (non-chest) or <4 weeks (chest or >30% bone marrow).
- •Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of trastuzumab deruxtecan. Note: Patients, if enrolled, should not receive live vaccine during the study and up to 390 days after the last dose of IMP.
- •Active and uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
- •Evidence of ongoing alcohol or drug abuse as assessed by the Investigator.
- •Any severe medical or psychiatric condition that, in the Investigator’s opinion, would preclude the patient’s participation in a clinical study
- •Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during study participation. Female subjects without childbearing potential are defined as women who are surgically sterile (hysterectomy or documented bilateral tubal ligation) or postmenopausal, defined as at least 12 months of spontaneous amenorrhea.
- •Known allergy or hypersensitivity to study drugs or any excipient.
- •Patients with contraindications to dexamethasone, as determined by the investigator in consultation with medical monitoring before enrolment.
- •Patients already undergoing chronic steroid treatment (e.g. 10 mg/day of prednisone/prednisolone or equivalent).
- •Patients requiring oxygen therapy at rest.
- •Documented pneumonitis/ILD prior to Cycle 1 Day
- •Uncontrolled or significant cardiovascular disease, including recent myocardial infarction (within 6 months), symptomatic heart failure (NYHA II–IV), elevated troponin without symptoms requiring cardiology evaluation, uncontrolled hypertension or arrhythmias, and QTcF prolongation >470 ms in females or >450 ms in males.
- •Impaired renal function with creatinine clearance <30 mL/min (calculated by Cockcroft-Gault formula).
- •Active or newly diagnosed CNS metastases, including meningeal carcinomatosis
- •Patients with recent (<28 days) respiratory infections
结局指标
主要结局
Cumulative incidence of patients who experience an ILD > G1 on high-resolution thorax CT scan during the treatment with T-DXd at 12 months from randomization by local Investigator’s judgement according to CTCAE, version 6.0. Discontinuation of T-DXd treatment for any reason other than ILD >G1 will be considered as a competing event.
Cumulative incidence of patients who experience an ILD > G1 on high-resolution thorax CT scan during the treatment with T-DXd at 12 months from randomization by local Investigator’s judgement according to CTCAE, version 6.0. Discontinuation of T-DXd treatment for any reason other than ILD >G1 will be considered as a competing event.
次要结局
- · Cumulative incidence of patients who experienced an ILD > G1 on HR thorax CT scan at 3, 6 and 9 months from randomization
- · Cumulative incidence of patients who experienced an any grade ILD on HR thorax CT scan at 3, 6, 9 and 12 months from randomization.
- · Proportion of patients diagnosed with ILD > G1 by central retrospective review of HR thoracic CT scans and clinical history within 12 months from randomization, according to CTCAE v6.0 and multidisciplinary team assessment, with timing of ILD development during treatment documented
- · Proportion of patients with specific radiological ILD patterns identified through centralized multidisciplinary discussion (radiologists, pneumologists, radiotherapists, thoracic surgeons, oncologists)
- · Cumulative incidence of patients who experienced nausea or vomiting (any grade and >G2) at 3, 6, 9 and 12 months from randomization
- · Cumulative incidence of patients who experienced AST/ALT liver enzyme elevation (any grade and >G2) at 3, 6, 9 and 12 months from randomization
- · Cumulative incidence of permanent T-DXd discontinuation due to drug-related AEs at 3, 6, 9 and 12 months from randomization
- · Proportion of patients requiring a dose reduction due to T-Dxd-related AEs.
- · Cumulative incidence of patients who experienced cough (any grade and >G2) according to cough symptom score (CSS) at 3, 6, 9 and 12 months from randomization.
- · Cumulative incidence of patients who experienced dyspnea (any grade and >G2) according to Modified Medical Research Council (mMRC) Dyspnea Scale at 3, 6, 9 and 12 months from randomization.
- · Changes in SpO2, FVC and DLCO at 3, 6, 9 and 12 months from randomization.
- • Worst AE and adverse drug reaction (ADR) grade for each AE type, according to NCI-CTCAE v. 6.0
- • Proportion of patients experiencing grade 3-4-5 AEs/ADRs for each AE/ADR type
- • Type, frequency, nature, and number of patients with serious AEs (SAEs), serious adverse drug reactions (SADRs) and suspected unexpected serious adverse reactions (SUSARs)
- · Change from baseline in each single scale of the EORTC QLQ-FA12 questionnaire assessed at planned timepoints (see Study Procedures)
- · Change from baseline in EQ-5D-5L health state profile, utility score (for QALY calculations), and EQ-VAS score using the EQ-5D-5L questionnaire assessed at planned timepoints (see Study Procedures)
- · Cumulative incidence of patients who experienced ILD stratified by history of radiotherapy to breast and/or thorax (including palliative radiotherapy to vertebral/costal sites)
研究者
Irene De Simone
Scientific
Istituto Di Ricerche Farmacologiche Mario Negri
研究点 (23)
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