NCT03447132已完成3 期
Multicentre, International Neoadjuvant Randomized Double-blind Trial Comparing Fulvestrant® to a Combination of Fulvestrant® and Palbociclib (CDK 4/6 Inhibitor) in Patients With Operable Luminal Breast Cancer Responding to Fulvestrant®
International Cancer Research Group, United Arab Emirates14 个研究点 分布在 8 个国家目标入组 354 人开始时间: 2017年12月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 354
- 试验地点
- 14
- 主要终点
- pCR according to Le Chevalier's classification
研究概览
简要总结
This is a multicenter, international, double-blind randomized Phase III study to evaluate the pathological complete response (pCR) according to Chevalier classification between Fulvestrant® and the combination of Fulvestrant® plus Palbociclib as neoadjuvant therapy of hormone-sensitive patients with operable luminal breast cancer.
Eligible patients will be assessed upfront using the OncotypeDX® molecular test (Recurrence Score <31).
详细描述
This is a multicenter, international, double-blind, randomized study.
Eligible patients based on inclusion/exclusion criteria will be assessed using OncotypeDX molecular test. Patients with low/intermediate risk (Recurrence Score <31) will be treated with the induction neoadjuvant Fulvestrant (500 mg (milligram) intra muscular(i.m) at Day 1, 14 and 28 and then every 4 weeks), plus Goserelin (3.6 mg subcutaneous (s.c) every 4 weeks, only for pre and peri-menopausal patients) for 4 months, followed by clinical and radiological assessment of the disease response.
Patients with objective response or stabilization will be randomized and treated for 4 additional months with:
- Fulvestrant 500 mg i.m every 4 weeks (+ Goserelin 3.6 mg s.c every 4 weeks, only for pre and peri-menopausal patients) and Placebo
or
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Written informed consent prior to beginning specific protocol procedures including expected cooperation of the patients for the treatment and follow-up must be obtained and documented according to the local regulatory requirements.
- •Postmenopausal women or pre-menopausal (with medical or surgical oophorectomy)
- •Performance status < 2 (according to WHO criteria).
- •Histologically confirmed non-metastatic breast cancer (Luminal A or B)
- •HR (hormone receptor ) positive (Estrogen or Progesterone)> 1%.
- •Her-2 negative (score 0 or 1 by immunochemistry), FISH (fluorescence in situ hybridization) negative if IHC (immuno-histochemistry) score 2).
- •Clinical stage II and IIIa.
- •No previous breast cancer treatment by surgery, radiotherapy, hormone therapy or chemotherapy.
- •Measurable or evaluable disease.
- •Hematology:
- •Neutrophil count ≥ 1.5 G/L.
- •Platelet count ≥ 100 G/L.
- •Leucocyte count > 3.0 G/L.
- •Hb> 9g/dl.
- •Hepatic function:
- •Total bilirubin ≤ 1.5 time the Upper Normal Limit (UNL).
- •ASAT (alanine aminotransferase aspartate transaminase ) ≤ 2.5xUNL.
- •ALAT (alanine aminotransferase) ≤ 2.5xUNL.
- •Alkaline phosphatase ≤ 2.5 time the upper normal limit (UNL).
- •Renal function:
- •Serum creatinine ≤1.5xUNL (and if Serum creatinine >1.5xUNL, creatinine clearance ≥50 mL/min).
- •Creatinine clearance ≥40 mL/min in case of MRI.
- •Metabolic function:
- •Serum magnesium ≥ lower limit of normal.
- •Serum calcium ≥ lower limit of normal.
- •No progressive heart disease and no anthracycline contraindication (normal LVEF ( left ventricular ejection fraction) according to the institution guidelines).
- •Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment.
排除标准
- •Male patients.
- •Her-2 positive tumors or unknown HR/Her-2 status.
- •Pregnancy or breast-feeding, or plan to become pregnant within 6 months post treatment.
- •No willingness to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months post treatment.
- •Any form of breast cancer other than those described in the inclusion criteria, particularly inflammatory and/or overlooked forms (stages IIIb or IV).
- •Non-measurable tumour.
- •Bilateral breast cancer.
- •Previous treatment for breast cancer including surgery for their disease or have had primary axillary dissection, radiotherapy and systemic therapy.
- •Patient with history of other cancer, except in situ cervical cancer or baso-cellular skin cancer, considered cured.
- •Patient has another disease, which is deemed incompatible with the inclusion in the protocol.
- •Heart, kidney, medullary, respiratory or liver failure. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment in the study.
- •History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease at baseline
- •Acute urinary infection, ongoing hemorrhagic cystitis.
- •Uncontrolled diabetes.
- •Symptomatic or progressive disorder of the central nervous system (CNS) Peripheral neuropathy > grade 2
- •Significant psychiatric abnormalities.
- •History of hypersensitivity to studied treatment or excipients
- •Known previous or ongoing abuse narcotic drug, other medication or alcohol
- •Any investigational agent within 30 days before initiation of study treatment.
- •No major surgical procedure within 28 days of initiation of treatment.
- •Subject unwilling or unable to comply with study requirement.
研究组 & 干预措施
Fulvestrant 500mg + Palbociclib 125mg
Active Comparator
- Goserelin 3.6 mg if pre or peri menopausal patient - duration 4 months
干预措施: Palbociclib 125mg (Drug)
Fulvestrant 500mg + Palbociclib 125mg
Active Comparator
- Goserelin 3.6 mg if pre or peri menopausal patient - duration 4 months
干预措施: Fulvestrant 500mg (Drug)
Fulvestrant 500mg + Palbociclib 125mg
Active Comparator
- Goserelin 3.6 mg if pre or peri menopausal patient - duration 4 months
干预措施: Goserelin 3.6 MG (Drug)
Fulvestrant 500mg + Placebos
Placebo Comparator
- Goserelin 3.6 mg if pre or peri menopausal patient - duration 4 months
干预措施: Fulvestrant 500mg (Drug)
Fulvestrant 500mg + Placebos
Placebo Comparator
- Goserelin 3.6 mg if pre or peri menopausal patient - duration 4 months
干预措施: Goserelin 3.6 MG (Drug)
Fulvestrant 500mg + Placebos
Placebo Comparator
- Goserelin 3.6 mg if pre or peri menopausal patient - duration 4 months
干预措施: Placebos (Drug)
结局指标
主要结局
pCR according to Le Chevalier's classification
时间窗: up to 5 years after the end of treatment period
pathological complete response will be assessed according to Le Chevalier's classification between two arms
次要结局
- pCR according to Sataloff's classification(up to 5 years after the end of treatment period)
- radiological response(up to 5 years after the end of treatment period)
- Rate of breast conservative surgery(up to 5 years after the end of treatment period)
- Safety /Tolerability of the combination Fulvestrant + Palbociclib(up to 5 years after the end of treatment period)
- DFS and OS(up to 5 years after the end of treatment period)
研究者
研究点 (14)
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