Neo-Adjuvant Endocrine Therapy in Post-Menopausal Hormone Receptor Positive HER 2 Neu Negative Node Positive Early-Stage Breast Cancer Patients With One Year of Letrozole.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Extent of Axillary Nodal Pathologic Complete Response (pCR)
研究概览
简要总结
The goal of this clinical trial is to learn whether letrozole, a hormone therapy drug, is effective in treating early-stage, hormone receptor-positive, HER2-negative breast cancer that has spread to nearby lymph nodes in postmenopausal women. The study will also evaluate the safety of taking letrozole for one year before surgery.
The main questions this study aims to answer are:
Can one year of letrozole eliminate cancer from the underarm (axillary) lymph nodes?
Can treatment with letrozole reduce the need for extensive lymph node surgery?
How safe and tolerable is long-term letrozole treatment?
This is a single-arm study, meaning all participants will receive letrozole. There is no placebo or comparison group.
Participants will:
Take letrozole 2.5 mg by mouth once daily for one year
Attend regular clinic visits for physical exams, blood tests, and imaging studies
Undergo surgery after completing treatment
Be followed for up to two years to monitor cancer recurrence and survival
详细描述
What is this study about?
This clinical trial is studying the use of letrozole, a hormone therapy medicine, in postmenopausal women with early-stage breast cancer that:
- Has spread to nearby lymph nodes,
- Is hormone receptor-positive (ER and/or PR positive), and
- Is HER2-negative. Letrozole is already widely used to treat hormone-positive breast cancer. In this study, it is given before surgery for a longer period than usual (one year) to see how well it works in shrinking cancer in the underarm (axillary) lymph nodes.
Why is this study being done? Many women with breast cancer that has spread to lymph nodes need axillary lymph node dissection (ALND), a surgery that removes many lymph nodes and can cause long-term side effects such as arm swelling (lymphedema), pain, and reduced arm movement.
This study aims to find out whether one year of letrozole treatment before surgery can:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Both participants and investigators are aware that the participants are receiving letrozole.
No placebo or comparator group is involved.
Open-label design allows for safety monitoring and practical administration in a neoadjuvant cancer setting.
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: Patients aged 18 to 69 years.
- •Menopausal Status: All patients must be postmenopausal, confirmed by serum estradiol levels or other clinical criteria.
- •Diagnosis: Histologically confirmed infiltrating ductal carcinoma of any grade.
- •Tumor Size: Primary tumor (T) category of T1 or T2 according to AJCC 8th edition, as measured by ultrasonography (USG) and mammography.
- •Node Involvement: N1 disease documented by clinical examination and USG, with histopathology confirmed by fine-needle aspiration cytology (FNAC) or core needle biopsy.
- •Hormone Receptor Status: Patients must be estrogen receptor (ER) positive and progesterone receptor (PR) positive/negative, with HER2 status negative.
排除标准
- •Age: Patients aged under 18 or over 69 years.
- •Tumor Size: Patients with a primary tumor larger than T2 >5cm or with N2 disease.
- •Histological Type: Infiltrating lobular carcinoma or other non-invasive breast cancer types.
- •Prior Treatments: Previous treatment with neoadjuvant endocrine therapy (NET) or neoadjuvant chemotherapy (NACT).
- •Comorbidities: Significant comorbidities that preclude administration of anesthesia or compromise patient safety.
- •Disease Characteristics: Patients with multicentric or multifocal disease, as defined by imaging or histopathological findings.
研究组 & 干预措施
Letrozole
Letrozole, Oral, 2.5mg daily, for 1 year
干预措施: Letrozole (Drug)
结局指标
主要结局
Extent of Axillary Nodal Pathologic Complete Response (pCR)
时间窗: From baseline (pre-treatment) to the end of one-year letrozole treatment
Proportion of postmenopausal, hormone receptor-positive (ER+/PR+), HER2-negative, node-positive breast cancer patients achieving pathological complete response (pCR) in axillary lymph nodes after one year of neoadjuvant letrozole therapy, assessed by sentinel lymph node biopsy (SLNBx).
次要结局
- Loco-Regional Relapse Rate(Assessed at 6, 12, and 24 months post-treatment initiation)
- Distant Relapse Rate(Assessed at 6, 12, and 24 months post-treatment initiation)
- Safety and Tolerability(Monitored continuously during the 1-year treatment period, reported at 3-month intervals.)