NL-OMON50735已完成3 期
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Fulvestrant (FASLODEX) with or without PD-0332991 (PALBOCICLIB) ± Goserelin in Women with Hormone Receptor-Positive, Her2-Negative Metastatic Breast Cancer Whose Disease Progressed after Prior Endocrine Therapy - PALOMA-3 /A5481023 Pfizer
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 35
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 99（—）
入选标准
- •Women 18 years of age or older, who are either:, - Postmenopausal, as defined
- •by at least one of the following criteria:, - Age * 60 years;, - Age <60
- •years and cessation of regular menses for at least 12 consecutive months with
- •no alternative pathological or physiological cause; and serum estradiol and FSH
- •level within the laboratory*s reference range for postmenopausal females;, -
- •Documented bilateral oophorectomy;, - Medically confirmed ovarian failure., OR,
- •- Pre/peri-menopausal, ie, not meeting the criteria for being postmenopausal.,
- •- Pre/perimeopausal women can be enrolled if amenable to be treated with the
- •LHRH agonist goserelin. Patients must have commenced treatment with goserelin
- •or an alternative LHRH agonist at least 4 weeks prior to randomization. But, if
- •patients have received an alternative LHRH agonist prior to study entry, they
- •must switch to goserelin for the duration of the trial., 2. Histologically or
- •cytologically proven diagnosis of breast cancer with evidence of metastatic or
- •locally advanced disease, not amenable to resection or radiation therapy with
- •curative intent., 3. Documentation of ER-positive and/or PR-positive tumor (*1%
- •positive stained cells) based on most recent tumor biopsy (unless bone-only
- •disease, see below) utilizing an assay consistent with local standards., 4.
- •Documented HER2-negative tumor based on local testing on most recent tumor
- •biopsy: HER2-negative tumor is determined as immunohistochemistry score 0/1+ or
- •negative by in situ hybridization (FISH/CISH/SISH) defined as a HER2/CEP17
- •ratio <2 or for single probe assessment a HER2 copy number <4., 5.
- •Patients must satisfy the following criteria for prior therapy:, - Progressed
- •during treatment or within 12 months of completion of adjuvant therapy with an
- •aromatase inhibitor if postmenopausal, or tamoxifen if pre- or perimenopausal.,
- •OR, - Progressed while on or within 1 month after the end of prior aromatase
- •inhibitor therapy for advanced/metastatic breast cancer if postmenopausal, or
- •prior endocrine treatment for advanced/metastatic breast cancer if pre- or
- •perimenopausal., One previous line of chemotherapy for advanced/metastatic
- •disease is allowed in addition to endocrine therapy., 6. Except where
- •prohibited by local regulations, all patients must agree to provide and have
- •available a formalin-fixed paraffin embedded (FFPE) tissue biopsy sample taken
- •at the time of presentation with recurrent or metastatic disease. A de novo
- •biopsy is required, if no archived tissue is available taken at the time of
- •presentation with recurrent/metastatic. The sole exception is those patients
- •with bone, only disease for whom provision of previous archival tissue only is
- •acceptable. Patients, who had surgery within the last 3 years (but without
- •neoadjuvant chemotherapy prior to surgery) and relapsed while receiving
- •adjuvant therapy, may provide a tumor specimen from that surgery., 7.
- •Measurable disease as defined by RECIST version 1.1, or bone-only disease.
- •Patients with bone-only metastatic cancer must have a lytic or mixed
- •lytic-blastic lesion that can be accurately assessed by CT or MRI. Patients
- •with bone-only disease and blastic-only metastasis are not eligible. Tumor
- •lesions previously irradiated or subjected to other loco, regional therapy will
- •only be deemed measurable
排除标准
- •1. Prior treatment with any CDK inhibitor, or fulvestrant, or with everolimus,
- •or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway., 2.
- •Patients with advanced/metastatic, symptomatic, visceral spread, that are at
- •risk of life-threatening complications in the short term (including patients
- •with massive uncontrolled effusions [pleural, pericardial, peritoneal],
- •pulmonary lymphangitis, and over 50% liver involvement)., 3. Known active
- •uncontrolled or symptomatic Central Nervous System (CNS) metastases,
- •carcinomatous meningitis, or leptomeningeal disease as indicated by clinical
- •symptoms, cerebral edema, and/or progressive growth. Patients with a history of
- •CNS metastases or cord compression are eligible if they have been definitively
- •treated (eg, radiotherapy,, stereotactic surgery) and are clinically stable off
- •anticonvulsants and steroids for at least 4 weeks before randomization., 4.
- •Current use of food or drugs known to be potent CYP3A4 inhibitors, drugs known
- •to be potent CYP3A4 inducers (for examples, see the Prohibited Medications
- •section), and drugs that are known to prolong the QT interval., 5. Major
- •surgery, chemotherapy, radiotherapy, or other anti cancer therapy within 2
- •weeks before randomization. Patients who received prior radiotherapy to * 25%
- •of bone marrow are not eligible independent of when it was received., 6. Any
- •other malignancy within 3 years prior to randomization, except for adequately
- •treated basal cell or squamous cell skin cancer, or carcinoma in situ of the
- •cervix., 7. QTc interval >480 msec (based on the mean value of the
- •triplicate ECGs), family or personal history of long or short QT syndrome,
- •Brugada syndrome or known history of QTc prolongation or Torsade de Pointes.,
- •8. Any of the following within 6 months of randomization: myocardial
- •infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE
- •Grade *2, atrial fibrillation of any grade, coronary/peripheral artery bypass
- •graft, symptomatic congestive heart failure, cerebrovascular accident including
- •transient ischemic attack, or symptomatic pulmonary embolism., 9. Impairment of
- •gastro-intestinal (GI) function or GI disease that may significantly alter the
- •absorption of palbociclib, such as history of GI surgery with may result in
- •intestinal blind loops and patients with clinically significant gastroparesis,
- •short bowel syndrome, unresolved nausea, vomiting, active inflammatory bowel
- •disease or diarrhea of CTCAE Grade >1., 10. Prior hematopoietic stem cell or
- •bone marrow transplantation., 11. Known abnormalities in coagulation such as
- •bleeding diathesis, or treatment with anticoagulants precluding intramuscular
- •injections of fulvestrant or goserelin (if applicable)., 12. Known or possible
- •hypersensitivity to fulvestrant, goserelin, any of their excipients or to any
- •palbociclib/placebo excipients., 13. Known human immunodeficiency virus
- •infection., 14. Other severe acute or chronic medical or psychiatric condition,
- •including recent or active suicidal ideation or behavior, or laboratory
- •abnormality that may increase the risk associated with study participation or
- •investigational product administration or may interfere with the interpretation
- •of study results and, in the judgment of the investigator, would make the
- •patient inappropriate for
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