Impact of Preoperative Endocrine Therapy, Menstrual Cycle, PAM50 Assessment and Ki67 Dynamics on Adjuvant Treatment Decisions in Hormone Receptor-positive and HER2-negative Patients With Early Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 504
- 试验地点
- 1
- 主要终点
- Influence of the menstrual cycle on initial Ki67 in premenopausal women
研究概览
简要总结
PEAK is a prospective, multicenter, non-interventional investigator-initiated trial (IIT) that aims to investigate the influence of the menstrual cycle phase on Ki67 in patients who either receive Tamoxifen, Aromatase inhibitors ± gonadotropin-releasing hormone (GnRH)-Analogues or nothing or no preoperative endocrine treatment as part of the clinical routine. The investigators moreover address the question whether PAM50 assessment in addition to Ki67 dynamics still impacts treatment recommendations.
详细描述
Background of the study Chemotherapy and anti-hormonal therapies improve the chances of cure for patients with early-stage hormone receptor (HR)-positive/HER2-negative breast cancer. However, only a few patients benefit from chemotherapy, as classical tumor characteristics such as grading, tumor size, and lymph node involvement in the armpit have a prognostic value but do not allow predictions about the effectiveness of chemotherapy. New treatment concepts, such as gene expression tests and preoperative endocrine therapy, aim to identify patients with a high risk of recurrence and provide them with optimized treatment. Additionally, initial study results indicate that a woman's menstrual cycle could influence the tumor's growth rate. These hints need to be investigated in larger studies to understand how the growth rate of a tumor in different phases of the menstrual cycle can be interpreted.
Purpose of the study The main objective of the PEAK study is to investigate to what extent the menstrual cycle phase influences the tumor growth rate (biomarker Ki67). To make a scientifically sound statement, the growth rate of the tumor in postmenopausal patients must also be examined. In addition, the impact of preoperative anti-hormonal therapy, the dynamics of the growth marker Ki67, and the individual genetic risk (PAM50 gene test) on recommendations for adjuvant therapy in clinical routine should be evaluated. Furthermore, the influence of the aforementioned markers on established clinical-pathological risk factors and the spread of tumor cells should be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •women ≥ 18 years of age
- •histologically proven unilateral primary non-metastatic invasive breast cancer
- •Estrogen receptor (ER)-/ or Progesterone receptor (PR)- positive and HER2-negative
- •Ki67 from core biopsy is available
- •no lymph-node involvement by clinical evaluation and ultrasound (cN0)
- •not amendable to neoadjuvant chemotherapy
- •surgery or planned surgery at the Department for Women's Health, Tuebingen or Freiburg
- •planned preoperative endocrine treatment with Tamoxifen, Aromatase inhibitors, Goserelin or nothing for 2 - 4 weeks
- •written informed consent
排除标准
- •ER-negative and PR-negative
- •HER2-positive
- •bilateral breast cancer
- •preexisting cancer disease within the last 10 years
- •preexisting invasive ipsi- or contralateral breast cancer (non-invasive ipsi- or contralateral breast cancer is not regarded as an exclusion criteria)
- •any systemic breast cancer therapy before inclusion into the trial
- •indication for neoadjuvant chemotherapy
- •any systemic therapy except Tamoxifen, Aromatase inhibitors, Goserelin before surgery
- •locally advanced, inoperable or metastatic breast cancer
- •pregnant or lactating patients
- •inadequate general condition (not fit for chemotherapy)
- •hormonal contraception within 6 months before inclusion
研究组 & 干预措施
Group A: Tamoxifen
Patients with early HR+/HER2- Breast cancer receiving Tamoxifen
Group B: Aromatase Inhibitor (+GnRH if premenopausal)
Patients with early HR+/HER2- Breast cancer receiving Aromatase Inhibitor (+GnRH if premenopausal)
Group C: Control group
no preoperative endocrine treatment
结局指标
主要结局
Influence of the menstrual cycle on initial Ki67 in premenopausal women
时间窗: duration of therapy and follow-up data (10 years)
The number of Ki67 positive cell nuclei will be estimated for the entire core biopsy in a semiquantitative evaluation in steps of 10% by a board certified pathologist as part of the clinical routine workup. Ki67 assessment will be conducted on breast core biopsy (I) and surgical specimen (II).
次要结局
- Influence of preoperative anti-hormonal therapy, dynamics of the growth marker Ki67 (evaluation of positive cell nuclei by pathologist), and individual genetic risk (PAM50 gene test) on recommendations for adjuvant therapy.(duration of therapy and follow-up data (10 years))