理由：目前尚未清楚每日较高剂量放射治疗在治疗乳腺癌方面是否与标准每日放射治疗同样有效。 目的：这项随机第三期试验研究加速疗程的每日较高剂量放射治疗合并同步追加照射，与标准每日放射治疗合并序贯追加照射相比，在治疗已接受手术切除的早期乳腺癌患者方面的效果。
适应症：Breast Cancer
入组条件
纳入标准
- Pathologically proven diagnosis of breast cancer resected by lumpectomy and whole breast irradiation with boost without regional nodal irradiation planned
- The patient must be female
- The patient must meet at least one of the three following criteria:
- A. Pathological stage I, II Breast Cancer AND at least one of the following:
- Age \< 50 years or
- Positive axillary nodes or
- Lymphovascular space invasion or
- or more close resection margins (\> 0 mm to ≤ 2 mm) or
- close resection margin and extensive intraductal component (EIC) \[Per College of American Pathologist (CAP) Recommendation\] or
- Focally positive resection margins or
- Non-hormone sensitive breast cancer (estrogen receptor (ER)- and progesterone receptor(PR)-negative) or
- Grade III histology or
- Oncotype recurrence score \> 25 or
- B. Pathological stage 0 breast cancer with nuclear grade 3 ductal carcinoma in situ (DCIS) and patient age \<50 years or
- C. Post-neoadjuvant pathological 0, I, II breast cancer resected by lumpectomy after neoadjuvant systemic therapy
- Study entry must be within 50 days from whichever comes later: last surgery (breast or axilla) or last chemotherapy. The day of surgery is Day "0".
- If multifocal breast cancer, then it must have been resected through a single lumpectomy incision with negative margins
- Breast-conserving surgery with margins defined as follows: (also see 3.1.3 for eligibility)
- Negative margins defined as no tumor at the resected specimen edge.
- Close resection margins \> 0 mm to ≤ 2 mm. as follows:
- One close resection margin and EIC (per College of American Pathologist (CAP) Recommendation)
- or more close resection margins.
- A focally positive resection margin
- For invasive breast cancer the axilla must be staged by one of the following:
- Sentinel node biopsy alone, if sentinel node is negative, i.e. any of the following:
- pN0: no regional lymph node metastasis identified histologically,
- pN0(i-): pN0 and immunohistochemical (IHC) negative, or
- pN0(i+): pN0 and IHc positive;
- Sentinel node biopsy alone, OR followed by axillary node dissection per investigator discretion, for clinically node negative patients as described below:
- microscopic sentinel node positive (pN1mic)
排除标准
- American Joint Committee on Cancer (AJCC) pathologic T4, N2 or N3, M1 pathologic stages III or IV breast cancer
- Treatment plan that includes regional node irradiation
- Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 5 years prior to study entry
- Prior invasive or in-situ carcinoma of the breast \[-prior lobular carcinoma in situ (LCIS) is eligible\]
- Two or more breast cancers not resectable through a single lumpectomy incision
- Bilateral breast cancer
- DCIS only (without an invasive component) and age ≥ 50 years
- DCIS nuclear grade 1 or 2 only (without an invasive component) and age \< 50 years
- Invasive breast cancer and low risk for 5-year in breast recurrence after lumpectomy with negative margins that does not meet one of the eligibility factors in 3.1.3.
- Unable to delineate on CT scan the extent of the target lumpectomy cavity for boost (Placement of surgical clips to assist in treatment planning of the boost is strongly recommended, see Section 6.4.2 for details)
- Suspicious unresected microcalcification, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign
- Non-epithelial breast malignancies such as sarcoma or lymphoma
- Paget's disease of the nipple
- Male breast cancer
- Prior radiotherapy to the breast or prior radiation to the region of the ipsilateral breast that would result in overlap of radiation therapy fields
- Intention to administer concurrent chemotherapy for current breast cancer.
- Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration;
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
- Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive
- Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception
- Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash
- Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent
入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。