KCT0008996尚未招募Unknown
Tailored axillary surgery with or without axillary lymph node dissection followed by radiotherapy in patients with clinically node-positive breast cancer (TAXIS). A multicenter randomized phase III trial. (OPBC-03/ SAKK 23/16 / IBCSG 57-18 / ABCSG-53 / GBG-101)
Yonsei University Health System, Gangnam Severance Hospital0 个研究点目标入组 1,500 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •Criteria for pre-enrollment
- •(1) Patients who have provided written informed consent in accordance with ICH/GCP regulations prior to study procedures.
- •(2) Patients with breast cancer diagnosed as lymph node positive by palpation or imaging.
- •(3) Female or male aged 19 years or older
- •(4) Patients able to complete a quality of life questionnaire
- •Criteria at time of enrollment
- •(1) Breast cancer with axillary lymph node metastasis that is AJCC/UICC stage II-III (histologically or cytologically confirmed in both the primary tumor and lymph nodes).
- •- Lymph node metastases are imaging confirmed and not detectable by palpation, but are pathologically confirmed.
- •- Lymph node metastases palpable by palpation (cN1-3) and pathologically confirmed
- •- Occult breast cancer with histologically proven axillary lymph node metastasis (cN1-4)
- •(2) Sentinel lymph node biopsy, including axillary lymph node dissection or frozen section, may be performed in the following cases
- •- Newly diagnosed cases
- •- Is a solitary recurrence or second ipsilateral breast cancer recurrence in the breast that has been disease-free for at least 3 years after breast-conserving surgery and sentinel lymph node biopsy and has not previously received axillary dissection or axillary radiation therapy
- •(3) Have had a clip inserted into the most suspicious axillary lymph node
- •(4) Completion of a quality of life questionnaire prior to treatment initiation
- •(5) WHO performance status of 0-2
- •(6) Patients who are able to undergo general anesthesia, breast cancer surgery, or radiation therapy
- •(7) Women of childbearing potential are using effective contraception, are not pregnant or lactating, and have agreed not to become pregnant during study treatment or for the period recommended by guidelines for adjuvant systemic therapy after treatment. All women of childbearing potential must have a negative pregnancy test prior to enrollment, and men must agree not to become pregnant during study treatment and for 6 months thereafter.
- •Criteria at Randomization
- •Positive breast cancer with axillary lymph node metastasis that is AJCC/UICC stage II-III (histologically or cytologically confirmed in both primary tumor and lymph nodes)
- •- Patients who have received neoadjuvant chemotherapy and have imaging confirmed lymph node metastases at the time of diagnosis and histologically (including ITC) confirmed axillary residual disease that is not palpable after neoadjuvant chemotherapy.
- •- Patients who received neoadjuvant chemotherapy and had palpable lymph node metastases at the time of diagnosis and histologically (including ITC) confirmed axillary residual disease after neoadjuvant chemotherapy.
排除标准
- •Criteria for pre-enrollment
- •(1) Stage IV breast cancer
- •(2) Breast cancer with clinical stage cN3c (cN3a and cN3b are allowed)
- •(3) Breast cancer with clinical stage cN2b (cN2a is allowed)
- •(4) Patients diagnosed with contralateral breast cancer within 3 years
- •(5) History of axillary surgery (excluding previous sentinel lymph node surgery for intraductal recurrence)
- •(6) History of receiving localized radiation therapy
- •(7) History of hematologic or primary solid malignancy in remission for at least 3 years from the time of pre-enrollment, except for treated cervical intraepithelial carcinoma or localized non-melanoma skin cancer
- •(8) History of treatment with any investigational drug within 30 days of pre-enrollment.
- •(9) In the opinion of the investigator, the patient's serious medical, psychiatric, psychological, familial, or geographic condition interferes with planned staging, treatment, and follow-up, and the patient's compliance or high risk for complications related to treatment is anticipated.
- •Criteria at randomization.
- •(1) Absence of clips at specimen mammography
- •(2) Presence of palpable residual disease in the axilla after TAS
- •(3) No sentinel lymph nodes identified in the axilla
研究者
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