A Phase III Study Comparing the Concurrent Versus the Sequential Administration of Chemotherapy and Aromatase Inhibitors, as Adjuvant Treatment of Post-menopausal Patients With Endocrine-responsive Early Breast Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
- 试验地点
- 74
- 主要终点
- Disease- free Survival (DFS)
研究概览
简要总结
Breast cancer is the most common form of cancer among women. For patients candidated for adjuvant chemotherapy and endocrine therapy the optimal timing for their has not been clearly defined yet.
详细描述
Breast cancer is the most common form of cancer among women in North America, Europe and Latin America. Because nearly 80% of breast cancers are endocrine-responsive tumors, the majority of patients candidates for adjuvant chemotherapy (CT) are also candidates for endocrine therapy (ET). The optimal timing (i.e. concomitant vs sequential administration) for the integration of these two treatments has not been clearly defined yet.
In patients with hormone receptor positive early stage breast cancer who are candidates to adjuvant chemotherapy and endocrine therapy, the optimal timing for the integration of these two treatment modalities has not been clearly defined yet.
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
- •Women with histological diagnosis of invasive breast cancer completely removed by surgery, any T, any N.
- •Postmenopausal status defined by at least one of the following conditions:
- •Aged 45-59 and satisfying one or more of the following criteria:
- •amenorrhea for ≥12 months and intact uterus;
- •amenorrhea for <12 months and follicle-stimulating hormone (FSH) within the postmenopausal range, including:
- •pts with hysterectomy
- •pts who have received hormone replacement therapy (HRT)
- •pts with chemotherapy-induced amenorrhea
- •bilateral oophorectomy at any age >18 years.
- •Primary tumor positive for Estrogen Receptors (ER) and/or Progesteron receptors (PgR) (≥1% tumor cells positive by immunohistochemistry or ≥ 10 fmol/mg cytosol protein by ligand binding assay).
- •Patients who are prescribed 5 years of endocrine therapy with an aromatase inhibitors (AI)
- •Indication for adjuvant chemotherapy- Patients with HER-2 positive tumors are eligible provided that they are prescribed trastuzumab according to registered schedule.
- •Signed informed consent.
排除标准
- •HRT currently assumed or during the month before randomization
- •Recurrent or metastatic disease
- •HER-2 positive tumors if treatment with trastuzumab is considered not appropriate/feasible
- •Concurrent illness that contraindicate adjuvant endocrine treatment and/or chemotherapy
- •Patients who have received Tamoxifen as part of any breast cancer prevention trial
- •Previous history of invasive breast cancer or other invasive malignancy within the previous 10 years, other than squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied
- •Concomitant severe disease which would place the patient at unusual risk
- •Concurrent treatment with experimental drugs
- •Patients treated with systemic investigational drugs within the past 30 days
研究组 & 干预措施
ARM B
Adjuvant chemotherapy + Aromatase inhibitors x 5 yrs (concurrent arm)
干预措施: Anastrozole or Letrozole or Exemestane (Drug)
ARM A
Adjuvant chemotherapy → Aromatase inhibitors x 5 yrs (sequential arm)
干预措施: Anastrozole or Letrozole or Exemestane (Drug)
结局指标
主要结局
Disease- free Survival (DFS)
时间窗: up to 15 years
the primary outcome indicator will be the so called DFS, defined as time elapsing between the date of randomization and the date of one of the following events, whichever occurs first, assessed up to 15 years: * Local Recurrence of disease * Regional recurrence of disease * Distant recurrence of disease * Contralateral invasive or intraductal breast cancer * Second primary malignancy other than breast * Death for any cause
次要结局
- Translational Study: genomic analysis(up to 15 years)
- Overall Survival (OS)(time between the date of randomization up to the date of death for any cause, assessed up to 15 years.)
- Translational Study: epigenetic analysis(up to 15 years)
- Translational Study: proteomic analysis(up to 15 years)
研究者
Lucia Del Mastro,MD
Director of S.S. Innovative Therapies Unit
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy