2025-523683-20-00招募中2 期
NoELA_No Endocrine therapy in small HR+ HER2- low relapse risk Luminal A early breast cancer, a single-arm de-escalation trial
Unicancer41 个研究点 分布在 1 个国家目标入组 630 人开始时间: 2026年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 630
- 试验地点
- 41
- 主要终点
- Relapse-free interval (RFI) is defined as the delay between initial treatment and the first occurrence of i) ipsilateral breast tumor recurrence, ii) distant or locoregional recurrence or iii) death from breast cancer, according to the STEEP system definition version 2.0 (Tolaney SM et al., JCO 2021)
研究概览
简要总结
To determine if women ≥ 60 years of age with clear margins of excision after surgery for node-negative breast cancer with tumors ≤ 1 cm and Luminal A characteristics (ER and PR positive, HER2⁻, and Ki67 ≤ 15%) who are treated with adjuvant radiotherapy (if they underwent breast-conserving surgery, BCS) and forgo adjuvant ET have an acceptable low risk of relapse or death from breast cancer.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal (underwent bilateral oophorectomy or non-chemo induced amenorrhea for 12 or more months) female participant ≥60 years of age.
- •The participant is willing and able to comply with the protocol for the duration of the study, including scheduled visits, treatment strategy, laboratory tests and other study procedures.
- •Participants must be affiliated with a Social Security System (or equivalent).
- •The participant must have signed a written informed consent form before any trialspecific procedures. When the participant is physically unable to give written consent, an impartial witness of her choice, independent from the investigator or the sponsor, can confirm the participant’s consent in writing.
- •New diagnosis of invasive carcinoma of the breast (ductal, tubular or mucinous) with primary tumor ≤1 cm on microscopic exam (pT1a-b), with no evidence of nodal or distant metastatic disease.
- •Contralateral breast described as BI-RADS 1 or 2 in diagnostic imaging.
- •Negative axillary node involvement by sentinel node biopsy or axillary node dissection (pN0). or Clinically negative axillary node involvement (cN0) after mandatory ultrasound exploration without surgical exploration of the axilla if BCS was performed.
- •ER positive (≥ 50%) and PR positive (> 20%), Ki67 low (≤15%) and HER2 negative (IHC or In Situ Hybridization approach) according to ASCO criteria.
- •Histological grade scored on the invasive component, 1 or 2 if pT1a or grade 1 if pT1b.
- •Treated by mastectomy or BCS with microscopically clear resection margins defined as “no-ink on tumor” or ≥1 mm for invasive and non-invasive disease or no residual disease on re-excision.
- •If BCS was performed, participants must have received or have scheduled adjuvant local radiotherapy within 3 months after surgery, as follows : - whole breast adjuvant radiotherapy, - with appropriate fractionation (15, 5, 16 or 25 fractions), as per current standards - with or without a boost to the tumor bed, - delivered in a sequential or simultaneous manner, as per radiation oncologist’s choice. - whole breast irradiation volumes will be defined as per current guidelines
- •No indication of adjuvant chemotherapy.
排除标准
- •Have received any neo-adjuvant treatment, including hormone therapy and chemotherapy.
- •History of non-breast cancer malignancies if not disease-free for > 5 years and considered low risk of recurrence except for treated carcinoma in situ of the cervix, endometrium or colon, melanoma in situ and basal or squamous cell carcinoma of the skin.
- •Non-malignant severe disease associated with a life expectancy < 10 years.
- •Women with BRCA1, BRCA2 or other high-risk breast cancer predisposing deleterious germline mutations.
- •Enrolled in another therapeutic study within 30 days prior to inclusion.
- •Unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.
- •Persons deprived of their liberty or under protective custody or guardianship.
- •Have received or are eligible for adjuvant chemotherapy.
- •Absolute contraindication for RT in case of BCS or patients who were treated with partial breast irradiation.
- •Have been treated with mastectomy and with adjuvant radiotherapy received or scheduled.
- •Invasive lobular breast cancer.
- •Bilateral breast cancer or history of other invasive ipsi- or contralateral breast cancer.
- •Multifocal or multicentric disease.
- •Disease limited to microinvasion only (< 1 mm).
- •Evidence of lymphovascular invasion.
研究组 & 干预措施
EXEMESTANE
Test
干预措施: EXEMESTANE (Drug)
LETROZOLE
Test
干预措施: LETROZOLE (Drug)
ANASTROZOLE
Test
干预措施: ANASTROZOLE (Drug)
TAMOXIFEN
Test
干预措施: TAMOXIFEN (Drug)
结局指标
主要结局
Relapse-free interval (RFI) is defined as the delay between initial treatment and the first occurrence of i) ipsilateral breast tumor recurrence, ii) distant or locoregional recurrence or iii) death from breast cancer, according to the STEEP system definition version 2.0 (Tolaney SM et al., JCO 2021)
Relapse-free interval (RFI) is defined as the delay between initial treatment and the first occurrence of i) ipsilateral breast tumor recurrence, ii) distant or locoregional recurrence or iii) death from breast cancer, according to the STEEP system definition version 2.0 (Tolaney SM et al., JCO 2021)
次要结局
- RFI of participants treated with adjuvant hormone therapy in the CANTO study
- Incidence of Ipsilateral DCIS, Contralateral DCIS, Invasive contralateral breast cancer at 5, 8 and 10 years*, Distant disease free survival (DDFS) and relapse free survival (RFS) rates at 5, 8, 10 years and overall survival (OS) at 5, 10 years * (RFI, DDFS, RFS and OS defined as per standardized STEEP v2.0 criteria)
- EORTC QLQC30 and EORTC QLQ-BR42, HADS questionnaires
- Bone-related events and osteopenia/osteoporosis diagnosis, dyslipidemia (hypercholesterolemia and hypertriglyceridemia) and cardiovascular events (myocardial infarction, stroke, and thromboembolic events), as per CTCAE v6.0.
研究者
Nourredine Nourredine AIT RAHMOUNE
Scientific
Unicancer
研究点 (41)
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