Clinical trial NCT03583580: Accelerated Partial Breast Irradiation With IMRT in Early Breast Cancer
Official title: A Multicenter Phase Ⅱ Prospective Clinical Trial of Accelerated Partial Breast Irradiation With IMRT After Breast-conserving Surgery in Early Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Neoplasms
Neoplasm Recurrence, Local
Keywords: Breast conserving surgery
Accelerate partial breast irradiation
intensity-modulated radiation therapy
phase II
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2018-07-11
Enrollment: 537
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the efficacy and toxicity of accelerated partial breast irradiation (ABPI) with intensity modulated radiation therapy (IMRT) in low-risk breast cancer treat with breast-conserving surgery.

Detailed description: This study is a national multicenter phase II prospective clinical trial to enroll low-risk breast cancer treat with breast-conserving surgery. All eligible patients will receive ABPI to a total dose of 40Gy, in 10 fractions, 4Gy/fx/day, within 2 weeks. Intensity modulated radiation therapy (IMRT) technique is used. During Follow up, the locoregional recurrence,survival,acute and late adverse events,and quality of life will be prospectively evaluated.

Eligibility criteria: Inclusion Criteria:

* Life Expectation: \> 5 years
* Enrollment date no more than 12 weeks after breast-conserving surgery or no more than 8 weeks after adjuvant chemotherapy
* Histologically confirmed diagnosis of invasive ductal carcinoma (grade 1-2), or mucinous carcinoma, or papillary carcinoma, or tubular carcinoma, or medullary carcinoma: primary tumor ≤ 3.0cm in maximum diameter and pN0; or histologically confirmed DCIS: primary tumor ≤ 2.5cm in maximum diameter, low-medium grade
* Unifocal tumour (confirmed by diagnostic MRI)
* No lymphovascular invasion
* ER positive (defined as medium-strongly nuclear staining in \>1% of the cancer cells)
* Negative radial resection margins of \>= 2 mm
* Surgical clips placed in the tumor bed
* Written informed consent.

Exclusion Criteria:

* Stage Ⅱ-Ⅲ
* Multifocal tumors
* Histologically confirmed diagnosis of invasive ductal carcinoma (grade 3), invasive micropapillary carcinoma, carcinoma of lobular in situ, invasive lobular carcinoma
* Paget's disease of the nipple
* Underwent oncoplastic surgery of ipsilateral breast
* Underwent neoadjuvant chemotherapy or hormonal therapy
* Previous or simultaneous contralateral breast cancer
* Undergone ipsilateral chest wall radiotherapy
* Active collagen vascular disease.

Primary outcomes:
measure: locoregional control rate
timeFrame: 5 years
Secondary outcomes:
measure: overall survival
timeFrame: 5 years
measure: disease-free survival
timeFrame: 5 years
measure: distant-metastasis survival
timeFrame: 5 years
Other outcomes:
measure: acute and late adverse events assessed by CTCAE v4.0
timeFrame: 5 years
measure: quality of life measured with BR-23 questionnaire
timeFrame: 2 years
measure: the incidence of second malignancy
timeFrame: 5 year
Locations:
city: Beijing
country: China
facility: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences
name: Shulian Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: