Hormone Therapy Initiation Immediately After Histological Diagnosis of Breast Cancer, Can it Make Any Difference?
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Tumor Biology
研究概览
简要总结
Breast Cancer is a public health issue worldwide. The time from diagnosis to treatment initiation varies from country to country and regionally within a country. Early diagnosis and prompt treatment initiation are key factors in patient survival rates.
Currently there is a rising trend, with a high percentage of patients with "Luminal" like breast cancer only undergoing adjuvant endocrine therapy.
Authors argue that tumor biology alterations after introducing very early endocrine therapy might have a prognostic and therapeutic impact and should be studied.
详细描述
Selected patients of female gender, above 50 y.o, and after a biopsy of Luminal-like Breast Cancer will go under aromatase inhibitor, from the diagnosis day till the surgical therapy to be decided (if so).In this study are going to be included patients that refuse surgical treatment, remaining this way in an "active surveillance". This last group is going to be randomised in order to recieve hormontherapy plus placebo vs hormontherapy plus acetolisalicilic acid.
In this way, authors want to investigate if:
- st This approach influences the tumor biology
- nd This approach influences tumor pathologic response and progression free survival.
- rd It is a valid approach and in which grade, for patients that refuse surgical treatment
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Menopausal woman of equal or above 50 y.o. with breast biopsy of Luminal like breast carcinoma
排除标准
- •informed consent
- •<50 y.o.
- •Pre-menopausal state
研究组 & 干预措施
Aromatase Inhibitor group
Female patients of 50 and above y.o. shall initiate hormone therapy (Letrozol 2.5 mg or Anastrazol 1 mg) immediately after the diagnosis until surgery.
干预措施: Aromatase Inhibitors (Drug)
Aromatase Inhibitor Active surveillance
Female patients of 50 and above y.o. that refuse surgery and therefor follow standard protocol (only Letrozol 2.5mg or Anastrazol 1 mg) until disease progression, death or will of surgery In this subgroup we are going to include, under HT, female patients with CDis,that refuse the standard treatment with surgery plus eventual rt and/or ht
干预措施: Aromatase Inhibitors (Drug)
Aromatase Inhibitor Active surveillance + aas
emale patients of 50 and above y.o. that refuse surgery and therefor follow standard protocol (only Letrozol 2.5mg or Anastrazol 1 mg plus acetilsalicilic acid) until disease progression, death or will of surgery In this subgroup we are going to include, under HT, female patients with CDis,that refuse the standard treatment with surgery plus eventual rt and/or ht
干预措施: Aromatase Inhibitors (Drug)
结局指标
主要结局
Tumor Biology
时间窗: 6 weeks
Effects of neoadjuvant aromatase inibitors on tumor biology in terms of RE,PR,Ki 67 measuring the after IA presurgical values
次要结局
- Tumor Pathology response(6 weeks)
- Disease free survival(1 5 and 10 years)
- Hormone treatment(1 5 and 10 years)
研究者
Zacharoula Sidiropoulou
Principal investigator
Centro Hospitalar Lisboa Ocidental