EUCTR2019-003581-41-FR进行中（未招募）1 期
EMBER: A Phase 1a/1b Study of LY3484356 Administered as Monotherapy and in Combination with Anticancer Therapies for Patients with ER+ Locally Advanced or Metastatic Breast Cancer and Other Select Non-Breast Cancers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 460
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
- •6.Have histological or cytological diagnosis of one of the following:
- •- Phase 1a and Phase 1b Parts A and B: ER+ and HER2- breast cancer with evidence of locally advanced unresectable or metastatic disease
- •- Phase 1b Part C: ER+ and HER2+ breast cancer with evidence of locally advanced unresectable or metastatic disease
- •- Phase 1a and Phase 1b Part D: ER+ recurrent, persistent, or metastatic EEC
- •- For breast cancer patients, ER and HER2 status assessed from the most recent tissue biopsy taken at the time of presentation with recurrent or metastatic disease.
- •oTo fulfill the requirement for ER+ disease by local testing, =1% of tumor cell nuclei must be immunoreactive by immunohistochemistry defined in the relevant American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guidelines (Allison et al. 2020).
- •oTo fulfill the requirement of HER2- disease by local testing on primary disease specimen, tumor must be HER2- according to ASCO/CAP guidelines for HER2 testing (Wolff et al. 2018).
- •oTo fulfill the requirement of HER2+ disease, tumor must be HER2+ as defined by in situ hybridization or FISH or IHC methodology in the relevant ASCO/CAP HER2 guidelines (Wolff et al. 2018).
- •- For EEC patients, ER+ status determined by local testing.
- •34.Phase 1a and Phase 1b Parts A and B: breast cancer patients must have either:
- •a. Untreated de novo metastatic disease or
- •b. Demonstrated sensitivity to prior ET by 1 of the following:
- •i. Documented clinical benefit (complete response [CR], PR, stable disease [SD] =24 weeks) to at least 1 prior ET in the metastatic setting or
- •ii. At least 24 months of adjuvant ET prior to recurrence, with the exception of patients who discontinued prior adjuvant ET earlier for reasons other than progressive disease.
- •35.Prior therapies received in the metastatic setting:
- •- Phase 1a: breast cancer patients may have had up to 3 prior regimens (no restrictions on types of prior therapies)
- •- Phase 1b Part A: patients may have had up to 1 prior regimen of any kind for advanced/mBC but must not have received a prior CDK4/6 inhibitor.
- •- Phase 1b Part B: patients may have had up to 2 prior regimens, no more than 1 of which may be ET and must have received a prior CDK4/6 inhibitor or be deemed inappropriate for or refused such therapy.
- •oCohort E4: patients must not have had prior everolimus
- •oCohort E5: patients must have a known PIK3Ca mutation as determined by local testing and must not have had prior alpelisib
- •- Phase 1b Part C: patients must have had at least 2 HER2-directed therapies for advanced disease and prior trastuzumab, pertuzumab, and TDM-1 required in any setting. Patients must have left ventricular ejection fraction (LVEF) of 50% or higher at baseline (determined by echocardiography or multigated acquisition scanning). Patients must not have received prior CDK4/6 inhibitor therapy or fulvestrant.
- •- Phase 1a EEC patients and Phase 1b Part D: patients must have progressed after platinum-containing chemotherapy, be deemed inappropriate for or declined platinum-containing chemotherapy, and must not have had prior fulvestrant or AI therapy.
- •7.Measurability of Lesions:
- •a) Breast cancer patients must have one of the following as defined by RECIST v1.1
- •(Eisenhauer et al. 2009):
- •?- Measurable disease
- •?- Nonmeasurable bone-only disease. Nonmeasurable bone-onl
排除标准
- •1. Have symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis.
- •2. Have a serious concomitant systemic disorder
- •3. Have pre-existing nausea, vomiting or diarrhea > grade 1 per CTCAE5.0.
- •4. Have visceral crisis.
- •5. Have inflammatory breast cancer .
- •6. Have an serious cardiac condition
- •7. Diagnosed and/or treated malignancy within 3 years prior to enrolment.
- •8.Have had major surgery within 28 days prior to randomization to allow for post-operative healing of the surgical wound and site(s).
- •9. Patients should refrain from consuming grapefruit, grapefruit juice, and grapefruit-containing products while on study due to the effect on CYP3A4 –
研究者
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