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)
- Conditions
- Neoplasms
- Registration Number
- KCT0008996
- Lead Sponsor
- Yonsei University Health System, Gangnam Severance Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 1500
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.
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-free survival (DFS)
- Secondary Outcome Measures
Name Time Method QoL, Quality of Life;Overall survival, OS;BCSS, Breast cancer-specific survival;TTLR, Time to local recurrence;TTRR, Time to regional recurrence;TTDR, Time to distant recurrence;Reported morbidity outcomes: Lymphedema and decreased shoulder range of motion;adverse events;Late radiotherapy-related adverse events;SSI, Surgical site infections