EUCTR2013-003170-27-ES进行中（未招募）1 期
Phase III study of Palbociclib (PD-0332991) in combination with Exemestane versus chemotherapy (capecitabine) in Hormonal Receptor (HR) positive/HER2 negative Metastatic Breast Cancer (MBC) patients with Resistance to non-steroidal Aromatase inhibitors ?The PEARL study? - PEAR
GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)0 个研究点目标入组 601 人开始时间: 2013年10月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 601
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
- Female
入选标准
- •1.The patient has signed the informed consent document.
- •2.Females with histologically confirmed MBC whose disease is resistant to previous non-steroidal aromatase inhibitors (letrozole or anastrozole), defined as:
- •?Recurrence while on or within 12 months after the end of adjuvant treatment with NSAI or
- •?Progression while on or within 1 month after the end of treatment with NSAI for advanced disease.
- •3.Previous chemotherapy is permitted either in the (neo)adjuvant setting and/or first line therapy for MBC.
- •4.It is not mandatory to have letrozole or anastrozole as the most recent treatment before randomization but progression of the MBC documented during receipt of the most recent systemic therapy before randomization should be documented.
- •5.Hormonal receptor positive (HR+) breast cancer based on local laboratory determination. HR+ defined as ? 1% positive cells by IHC for ER and/or PgR.
- •6.Documented HER2 negative breast cancer based on local laboratory determination on most recent tumor biopsy. HER2 negative tumor is determined as IHC score 0 or 1+ or negative by ISH (FISH/CISH/SISH) defined as a HER2/CEP17 ratio < 2 or for single probe assessment a HER2 copy number < 4.
- •7.Measurable disease or lytic bone lesions in the absence of measurable disease according to RECIST 1.1 criteria.
- •8.Patient is at least 18 years of age.
- •9.Eastern Cooperative Oncology Group (ECOG) Performance Status ? 1.
- •10.Life expectancy ? 12 weeks.
- •11.Adequate organ and bone marrow function defined as follows:
- •?ANC ? 1,500/mm3 (1.5x109/L)
- •?Platelets ? 100,000/mm3 (100x109/L)
- •?Hemoglobin ? 9g/dL (90g/L)
- •?Serum creatinine ? 1,5xULN or estimated creatinine clearance ? 60 mL/min as calculated using the standard method for the institution
- •?Total serum bilirubin ? 1,5xULN (? 3.0xULN if Gilbert´s disease)
- •?AST and/or ALT ? 3.0xULN (?5.0xULN if liver metastases present)
- •?Alkaline phosphatase ? 2.5xULN (?5.0xULN if bone or liver metastases present)
- •12.Postmenopausal women defined as women with:
- •?Prior bilateral surgical oophorectomy, or
- •?Medically confirmed post-menopausal status defined as spontaneous cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause.
- •13.Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE version 4.0 Grade ? 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator´s discretion).
- •14.Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- •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 348
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 348
排除标准
- •1. Have received more than 1 prior chemotherapy regimen for MBC. NOTE: Other previous anticancer endocrine treatments for advanced disease are allowed.
- •2. Patients with advanced, 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 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 with local therapy (eg, radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization.
- •4. Prior treatment with any CDK4/6, mTOR or PI3K inhibitor [any agent whose mechanism of action is to inhibit the PI3 kinase-mTOR pathway] or capecitabine.
- •5. Prior treatment with exemestane in the metastatic setting. If the patient has received exemestane in the adjuvant setting and developed MBC, she will be eligible for the study provided:
- •?She has received letrozole/anastrozole as first-line MBC and progressed.
- •?At least 1 year has elapsed since the end of adjuvant exemestane treatment.
- •6. Patients treated within the last 7 days prior to randomization with:
- •?Food or drugs that are known to be CYP3A4 inhibitors
- •?Drugs that are known to be CYP3A4 inducers
- •?Drugs that are known to prolong the QT interval
- •7. Major surgery, chemotherapy, radiotherapy, any investigational agent or other anti-cancer therapy within 4 weeks before randomization. Patients who received prior radiotherapy to ? 25% of bone marrow are not eligible independent of when it was received.
- •8. Diagnosis of 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.
- •9. QTc > 480msec (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 (TdP).
- •10. Uncontrolled electrolyte disorders that can compound the effects of a QTc-prolonging drug (eg, hypocalcemia, hypokalemia, hypomagnesemia).
- •11. Any of the following within 6 months of randomization: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE version 4.0 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.
- •12. Difficulties to swallow tablets, malabsorption syndrome disease significantly affecting gastrointestinal function, resection of the stomach or small bowel, or active inflammatory bowel disease or chronic diarrhea.
- •13. Known hypersensitivity to exemestane, palbociclib, capecitabine or any of their excipients.
- •14. Any of the following contraindications for chemotherapy with capecitabine:
- •?Known deficiency or family history of deficiency of dihydropyrimidine dehydrogenase.
- •?Requirement for concurrent use of the antiviral agent sorivudine (antiviral) or chemically related analogues, such as brivudine.
- •15. Known human immunodeficiency virus infection.
- •16. Other severe acute or chronic medical or
研究者
相似试验
进行中（未招募）
1 期
A study for patients with metastatic breast cancer (hormone receptor-positive, negative HER2 and resistance to non-steroidal aromatase inhibidors) comparing palbociclib + exemestane versus capecitabine.Patients with hormonal receptor positive and HER2 negative MBC who are resistant to prior NSAI therapy.MedDRA version: 19.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864EUCTR2013-003170-27-IEGEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)550
进行中（未招募）
1 期
A study for patients with advanced breast cancer (hormone receptor-positive, negative HER2 and resistance to non-steroidal aromatase inhibidors) comparing palbociclib + exemestane versus capecitabine.EUCTR2013-003170-27-LVGEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)601
进行中（未招募）
1 期
A study for patients with metastatic breast cancer (hormone receptor-positive, negative HER2 and resistance to aromatase inhibidors) comparing palbociclib + exemestane versus capecitabine.Patients with hormonal receptor positive and HER2 negative MBC who are resistant to prior aromatase inhibitors therapy.MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864EUCTR2013-003170-27-ATGEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)596
进行中（未招募）
1 期
A study for patients with advanced breast cancer (hormone receptor-positive, negative HER2 and resistance to non-steroidal aromatase inhibidors) comparing palbociclib + exemestane versus capecitabine.EUCTR2013-003170-27-HUGEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)348
进行中（未招募）
1 期
A study of palbociclib in addition to standard endocrine treatment in hormone-receptor positive, HER2 negative patients with residual disease after neoadjuvant chemotherapy and surgery (PENELOPE-B trial).About one-third of patients with hormone-receptor positive, HER2 negative breast cancer and residual disease after standard of care - including adequate surgery - have a substantial risk of relapse despite the use of adjuvant endocrine therapy.MedDRA version: 21.1Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10006200Term: Breast cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10006202Term: Breast cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10006201Term: Breast cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10071113Term: Node-positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10025025Term: Lumpectomy (breast cancer)System Organ Class: 100000004865MedDRA version: 20.0Level: LLTClassification code 10073289Term: Premenopausal breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 23.0Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10EUCTR2013-001040-62-ATGBG Forschungs GmbH1,250