NCT02511639已完成3 期
MAINtenance Afinitor: A Randomized Trial Comparing Maintenance Aromatase Inhibitors (AIs) + Everolimus (Afinitor) vs AIs in Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients With Disease Control After First Line Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 16
- 主要终点
- Progression free survival
研究概览
简要总结
The purpose of this study is to compare maintenance Aromatase Inhibitors (AIs) + everolimus with Aromatase Inhibitors alone after 1st line chemotherapy in patients with HR+ metastatic breast cancer.
详细描述
The purpose of this study is:
- to compare the progression free survival (PFS) of AIs/everolimus to AIs administered as maintenance therapy in HR+ advanced breast cancer patients with disease control (Complete Response (CR), Partial Response (PR) or Stable Disease (SD))after 1st line chemotherapy.
- To evaluate the overall survival
- To assess the safety profile
- To evaluate the response rate
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •>18 years old women with metastatic breast cancer
- •Histological confirmation of hormone-receptor positive (defined as at least 10% of estrogen receptor (ER) and/or progesterone receptor (PgR) positivity) and human epidermal growth factor receptor 2 (HER2) negative (score 0-1+ in immunohistochemistry or FISH negativity) breast cancer
- •Postmenopausal status
- •One line of chemotherapy for metastatic disease; patients must have received a minimum of 6 cycles of chemotherapy in order to be eligible, and must have obtained disease control (CR or PR od SD)
- •Eastern Cooperative Oncology Group (ECOG) Performance status < 2
- •Adequate bone marrow and coagulation function
- •Adequate liver function
- •Adequate renal function
- •Fasting serum cholesterol ≤ 300 mg/dl or 7.75 mmol/L and fasting triglycerides ≤ 2.5 × upper limit of normal (ULN). In case one or both of these thresholds are exceeded, the patient can only be included after initiation of statin therapy or other lipid lowering drugs (eg fibrates), and when the above mentioned values have been achieved
- •Fasting glucose < 1.5 × ULN
- •Written informed consent obtained before any screening procedure and according to local guidelines.
排除标准
- •HER2-overexpressing patients by local laboratory testing (immunohistochemistry 3+ staining or in situ hybridization positive)
- •Previous treatment with mammalian target of rapamycin (mTOR) inhibitors
- •Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin)
- •More than one chemotherapy line for metastatic disease
- •Treatment with angiogenetic compounds as maintenance therapy (eg. bevacizumab)
- •Radiotherapy within four weeks prior to enrollment except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture which can then be completed within two weeks prior to enrollment. Patients must have recovered from radiotherapy toxicities prior to enrollment
- •Symptomatic central nervous system metastases
- •Patients with a known history of HIV positivity
- •Active, bleeding diathesis, or on oral anti-vitamin K medication (except low dose warfarin and acetylsalicylic acid or equivalent, as long as the international normalized ratio (INR) is ≤ 2.0)
- •Any severe and / or uncontrolled medical conditions such as:
- •Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months prior to enrollment, serious uncontrolled cardiac arrhythmia
- •Uncontrolled diabetes as defined by fasting serum glucose > 1.5 × ULN
- •Acute and chronic, active infectious disorders and nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy
- •Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)
- •Significant symptomatic deterioration of lung function. If clinically indicated, pulmonary function tests including measures of predicted lung volumes, diffusion capacity of lung for carbon monoxide (DLco) and O2 saturation at rest on room air should be considered to exclude restrictive pulmonary disease, pneumonitis or pulmonary infiltrates.
- •Patients who test positive for hepatitis B or C (patients who test negative for hepatitis B virus (HBV)-DNA, HBsAg, and HBcAb but positive for HBsAb with prior history of vaccination against Hepatitis B will be eligible)
- •Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme Cytochrome P3A (Rifabutin, Rifampicin, Clarithromycin, Ketoconazole, Itraconazole, Voriconazole, Ritonavir, Telithromycin) within the last 5 days prior to enrollment
- •History of non-compliance to medical regimens
- •Patients unwilling to or unable to comply with the protocol
研究组 & 干预措施
Arm A: Everolimus & Aromatase inhibitors
Experimental
Everolimus 10 mg po daily + Aromatase inhibitors (Exemestane 25 mg po daily or Letrozole 2.5 mg po daily or Anastrozole 1 mg po daily)
干预措施: Everolimus (Drug)
Arm A: Everolimus & Aromatase inhibitors
Experimental
Everolimus 10 mg po daily + Aromatase inhibitors (Exemestane 25 mg po daily or Letrozole 2.5 mg po daily or Anastrozole 1 mg po daily)
干预措施: Aromatase Inhibitors (Drug)
Arm B: Aromatase inhibitors
Active Comparator
Aromatase inhibitors (Exemestane 25 mg po daily or Letrozole 2.5 mg po daily or Anastrozole 1 mg po daily)
干预措施: Aromatase Inhibitors (Drug)
结局指标
主要结局
Progression free survival
时间窗: Up to 2 years after randomisation
PFS is defined as the time from randomization to the first documentation of objective disease progression or death from any cause
次要结局
- Overall survival(Up to 2 years after randomisation)
- Response rate(Every 12 weeks during treatment, up to 2 years after randomisation)
- Safety profile(Baseline and every 4 weeks during treatment, up to 2 years after randomisation)
研究者
Pierfranco Conte
MD, PhD
Istituto Oncologico Veneto IRCCS
研究点 (16)
Loading locations...
相似试验
已完成
不适用
Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Non-Metastatic, Post Menopausal Breast Cancer PatientsBreast CancerNCT01051609Jonsson Comprehensive Cancer Center27
招募中
3 期
MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer (MATAO)Ovarian Neoplasm EpithelialFallopian Tube NeoplasmsPeritoneal NeoplasmsHigh-grade Serous Ovarian Carcinoma (HGSOC)Low-grade Serous Ovarian Carcinoma (LGSOC)Ovarian Endometrioid CarcinomaNCT04111978Swiss GO Trial Group540
进行中（未招募）
3 期
Metronomic Capecitabine Plus Aromatase Inhibitor for First Line Treatment in HR(+), Her2(-) Metastatic Breast CancerBreast CancerNCT02767661Sun Yat-sen University240
招募中
3 期
MAintenance Therapy with Aromatase inhibitor in epithelial Ovarian cancerepithelial ovarian cancer2024-511219-78-00Swiss GO Trial Group300
进行中（未招募）
1 期
MAintenance Therapy with Aromatase inhibitor in epithelial Ovarian cancerPatients with low and high grade serous and endometrioid ovarian cancer patients.EUCTR2019-002264-27-ATSwiss GO Trial Group540