CTIS2023-503708-10-00招募中1 期
An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men with Locally Advanced or Metastatic ER+/HER2- Breast Cancer with an ESR1 Mutation - SMX 22-002
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 444
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1. Age =18 years of age or a country's minimal age of maturity or greater., 7. Locally advanced or metastatic breast cancer with either measurable (according to RECIST 1.1 [Eisenhauer, et al, 2009]) or non-measurable lesions., 8. Subjects may have received 1 cytotoxic chemotherapy regimen in the metastatic disease setting prior to study entry but must have recovered from chemotherapy acute toxicity excluding alopecia, and Grade 2 peripheral neuropathy. A washout period of at least 14 days is required between last chemotherapy dose and entry into the study. (Antibody drug conjugates [ADC] and poly (ADP-ribose) polymerase [PARP] inhibitors are considered systemic chemotherapy.), 9. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1, 12. Brain metastases are allowed only if the following 4 parameters hold: a. Asymptomatic, b. Definitively treated (e.g., radiotherapy, surgery), c. Not requiring steroids up to 4 weeks before study treatment initiation, AND d. Central nervous system disease stable for >3 months prior to registration as documented by magnetic resonance imagining (MRI)., 10. Adequate organ function as shown by: a. absolute neutrophil count (ANC) =1,000 cells/mm3 (=1 g/L) b. platelet count =100,000 cells/mm3 (=100 g/L) c. hemoglobin =8.0 g/dl (80 g/L) d. ALT and AST levels =3 upper limit of normal (ULN) or =5 in the presence of liver metastasis e. total serum bilirubin =1.5 X ULN (=3 X ULN for subjects known to have Gilbert Syndrome) f. alkaline phosphatase level =3 ULN g. creatinine clearance of 40 mL/min or greater as calculated by the Cockcroft-Gault formula or by a standard method used by the investigational site., 11. Able to swallow tablets, 13. Able to understand and voluntarily sign a written informed consent before any screening procedures., 2. Pre- or postmenopausal women or men. Postmenopausal women are defined as: a. =60 years of age with no vaginal bleeding over the prior year, or b. <60 years with premature menopause or premature ovarian failure,” which manifests itself with secondary amenorrhea for at least 1 year and follicle stimulating hormone (FSH) and estradiol levels in the postmenopausal range according to institutional standards, or c. surgical menopause with bilateral oophorectomy., 3. Every attempt should be made to obtain a biopsy of metastatic breast cancer tissue, when safe and feasible, to provide histological or cytological confirmation of ER+/HER2- disease as assessed by a local laboratory, according to American Society of Clinical Oncology/College of American Pathologists guidelines, using slides, paraffin blocks, or paraffin samples. If a biopsy is done, it may undergo genomic testing at some point to assess for ESR1 mutations and correlation with ctDNA results. If a biopsy is not possible or inappropriate from a clinical standpoint, the ER and HER2 status from the subject’s most recent biopsy must confirm that the subject is ER+ and HER2-., 4.Locally advanced and/or metastatic breast cancer with radiological or clinical evidence of progression on an AI in combination with either palbociclib or ribociclib as their first hormonal treatment for metastatic disease. Before starting study treatment, subjects should have stopped any CDKi for at least 14 days. The subject may have received hormonal treatment in the adjuvant setting and up to 2 prior lines of endocrine therapy for metastatic disease. No prior adjuvant CDK4/6 inhibitor is allowed., 5. No evidence of progress
排除标准
- •1. Lymphangitic carcinomatosis involving the lung., 9. History of a PE, DVT, or any known thrombophilia., 11. On concomitant strong CYP3A4 inhibitors such as clarithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, or tipranavir., 18. Sexually active premenopausal women and men unwilling to use contraception, 12. On strong and moderate CYP3A4 inducers such as amprenavir, barbiturates, carbamazepine, clotrimazole, dexamethasone, efavirenz, ethosuximide, griseofulvin, modafinil, nevirapine, oxcarbazepine, phenobarbital, phenytoin, chronic prednisone treatment, primidone, rifabutin, rifampin, rifapentine, ritonavir, or topiramate., 2. History of Grade 3 or Grade 4 interstitial lung disease (ILD) on previous therapy., 20. History of non-compliance to medical regimens., 10. Lasofoxifene is not recommended for use in subjects with conditions that place them at increased risk for VTEs (such as severe congestive heart failure [CHF] or prolonged immobilization)., 3. Visceral crisis in need of cytotoxic chemotherapy as assessed by the investigator., 4. Prior progression of disease on abemaciclib, fulvestrant, or other selective estrogen receptor degrader (SERD) therapy., 5. Subjects with a known hypersensitivity to fulvestrant or to any of the excipients., 17. Positive serum pregnancy test (only if premenopausal)., 15. Known infection with HIV, Hepatitis B virus (HBV), or Hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antibody [HbsAg] test and a positive hepatitis B core antibody {HbcAb] test, accompanied by a negative HBV DNA test) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA., 16. History of malignancy within the past 5 years (excluding breast cancer), except basal cell or squamous cell carcinoma of the skin curatively treated by surgery. For history of other cancers considered to have a low risk of recurrence, discussion with the Medical Monitor is required, 19. Women who are breast feeding, 6. Radiotherapy within 30 days prior to Visit 0 (Day 1) except in case of localized radiotherapy for analgesic purposes or for lytic lesions at risk of fracture, which can then be completed within 7 days prior to Visit 0 (Day 1). Subjects must have recovered from radiotherapy toxicities prior to Visit 0 (Day 1)., 21. Unwilling or unable to comply with the protocol, 22. Current participation in any clinical research trial involving an investigational drug or device within the last 30 days, 7. Known RB1 mutations or deletions that in the opinion of the investigator confer resistance to CDK4/6i. (Screening for RB1 mutation is not required for entry.), 8. History of long QTc (Q-T interval corrected for heart rate) syndrome or a QTc of >480 msec, 13. Any significant co-morbidity that would impact the study or the subject’s safety, including subjects with significant malabsorption. Since the occurrence of ILD has been reported with CDKi, subjects with a history of ILD and those with severe dyspnea at rest or requiring oxygen therapy should not enter the study., 14. Active systemic bacterial or fungal infection (requiring intravenous [IV] antibiotics or antifungal drugs at the time of initiating study treatment).
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