EUCTR2022-001181-36-ES进行中（未招募）1 期
A phase 2 trial of neoadjuVAnt muLti-agENt chemotherapy or patritumab deruxtecan (HER3-DXd; HER3-DXd) with or without endocrINE therapy for high-risk HR+/HER2- breast cancer – VALENTINE trial - VALENTINE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- SOLTI
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed ICF
- •2. Male/female . At least 18 years old
- •3. Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast untreated and recently diagnosed, Stage II to stage IIIB breast cancer, Absence of distant metastasis. At least 1 lesion = 10 mm by MRI
- •4. ER-positive and/or PgR-positive and HER2-negative tumor
- •1. Signed ICF
- •2. Male/female . At least 18 years old
- •3. Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast untreated and recently diagnosed, Stage II to stage IIIB breast cancer, Absence of distant metastasis. At least 1 lesion = 10 mm by MRI
- •4. ER-positive and/or PgR-positive and HER2-negative tumor
- •5. Ki67% = 20% locally assessed and/or high genomic risk (defined by gene signature): Oncotype DX® RS = 26, Mammaprint® = Risk of Recurrence High or Prosigna® ROR = 60.
- •6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- •7. Breast cancer eligible for primary surgery.
- •8. Availability of pre-treatment tumor tissue sample of FFPE tumor block from primary tumor for biomarker analysis.
- •9. Eligible for neoadjuvant chemotherapy
- •10. Eligible for surgery.
- •11. Adequate hematologic and end-organ function
- •12. willing and able to comply with trial procedures.
- •13. Women of childbearing potential must have confirmed negative serum pregnancy test
- •14. Female subjects must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the time of final study drug administration.
- •15. Women of CBP must be willing to use highly effective methods of contraception.
- •16. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception and fetal protection for the duration of neoadjuvant treatment phase and after the last dose of treatment according to protocol.
- •17. Male subjects must not freeze or donate sperm starting at screening and throughout the study period, and for at least 4 months after the final study drug administration.
- •18. Postmenopausal or pre-menopausal
- •19. Patients must have the ability to swallow oral medication.
- •20. Baseline LVEF = 50%
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Metastatic (Stage IV) breast cancer.
- •2. Bilateral invasive breast cancer.
- •3. Any treatment for the currently diagnosed BC prior to enrollment.
- •4. Patients in whom a primary tumor excisional biopsy was performed
- •5. Prior treatment with a HER3 antibody, topoisomerase I inhibitor, with an ADC which consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., DS-8201) and with a govitecan derivative (e.g., IMMU-132).
- •6. Patient has active cardiac disease or a history of cardiac dysfunction including any of the following:
- •7. Medical history of clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or who are suspected to have these diseases by imaging at screening period.
- •8. Major surgical procedure or significant traumatic injury within 28 days prior to randomization.
- •9. Assessment by the investigator to be unable or unwilling to comply with the requirements of the protocol.
- •10. Patients with a history of any malignancy are ineligible (some exception detailed in protocol)
- •11. Current severe, uncontrolled systemic disease or other factors which in the Investigator’s opinion makes it undesirable for the subject to participate in the study or which would jeopardize compliance with the protocol
- •12. Concurrent, serious, uncontrolled infections or current known infection with HIV or active hepatitis B and/or hepatitis C
- •13. History of significant co-morbidities that, in the judgment of the investigator, may interfere with the conduction of the study, the evaluation of response, or with ICF.
- •14. Known hypersensitivity to either the drug substance components or inactive ingredients in the drug product or history of severe hypersensitivity reactions to other monoclonal antibodies.
- •15. History of exposure to cumulative anthracycline
- •16. Any history of interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis), has current ILD, or is suspected to have such disease by imaging during screening.
- •17. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder and any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement.
- •18. Has unresolved toxicities from previous anticancer therapy
- •19. Non-eligible for taxanes therapy.
- •20. Is receiving chronic systemic corticosteroids dosed at >10 mg prednisone or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to Cycle 1 Day 1.
- •21. Evidence of any leptomeningeal disease.
- •22. Has clinically significant corneal disease.
- •23. Female subject who is pregnant or breastfeeding or intends to become pregnant during the study.
- •24. Subjects who are currently receiving chloroquine or hydroxychloroquine. A washout period of > 14 days is required prior to randomization or Cycle 1 Day 1
研究者
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