Prospective Observational Study for Local Radiotherapy in Breast Cancer Patients Receiving Nipple Sparing Mastectomy With Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- freedom from local and regioanl recurrence rate : FFLRR rate
研究概览
简要总结
The prospective observational study of radiation therapy is conducted on the nipple-areola complex(close resection margin at primary tumor site) or regional lymph nodes(including axilla and supraclavicular lymph node) with a high risk of local recurrence in nipple-sparing mastectomy with reconstruction, we're going to analysis the effects of radiation therapy and cosmetic effects.
By evaluating survival rate, recurrence pattern(local lymph node and metastasis to the whole body), side effects, cosmetic effects, from the patients who have gone through Nipple Sparing Mastectomy with reconstruction.
详细描述
For the last 20years, Breast Conservation Surgery and postoperative radiotherapy were the well established standard treatment, proven by various clinical trial studies, About 20-50% of breast cancer patients with large tumors, small breasts, or multiple tumors were still considered for Radical mastectomy.
In this case, Nipple Areola Complex (NAC) removal, significantly increases the amputation sensation of the patient and reduces breast contour, cosmetic satisfaction, physical balance, and psychological burden.
For this reason, recently, Nipple Sparing Mastectomy with reconstruction, which does not reduce treatment effect and maintain breast contour function is more considered.
It is reported that from Radical mastectomy specimens, possible tumor cell invasion in Nipple-Areola Complex is about 20%(0-58%).
local recurrence of breast cancer patient for nipple sparing mastectomy is reported to be about 0-28.4%.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patient who have pathologic confirmation of Ductal carcinoma in situ or invasive caricinoma
- •patient who undergone nipple sparing mastectomy with construction
- •patient who considered radiotherapy in breast cancer at stage IIB or lower (exclude ≥T3, ≥N2)
- •patient who have not distant metastasis
- •age >19 years old
- •patinet who have an ECOG of 0-2
- •patient who have not comorbidities(collagne vascular disease, such as systemic lupus erythermatosis, scleroderma, dermatomyositis)
- •patient who have not prior radiotherapy history in treatment site
- •patient who have not pregnancy or lacting
- •patient who have consent in writing to participate in research
排除标准
- •patient who undergone construction after nipple sparing mastectomy
- •patient who have ≥T3, ≥N2 in breast cancer
- •patient who have diastant metastasis
- •patient who have comorbidities(collagne vascular disease, such as systemic lupus erythermatosis, scleroderma, dermatomyositis)
- •patient who have treatment history in treatment site
- •patinet who have an ECOG 3-4
- •age < 20years old
- •patient who have pregnancy or lacting
- •patient who have not consent in writing to participate in research
结局指标
主要结局
freedom from local and regioanl recurrence rate : FFLRR rate
时间窗: up to 5 years
evaluate the freedom from local and regioanl recurrence rate in nipple-areola complex(close resection margin at primary tumor site) or regional lymph nodes(including axilla and supraclavicular lymph node)
次要结局
- relapse-free or overall survivor : RFS and OS(up to 5 years)
- toxicity and contraction of the implant, quality of life(up to 5 years)
研究者
Tae Hyun Kim
Principal Investigator
National Cancer Center, Korea