Accelerated Partial Breast Irradiation With IMRT in Early Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

A Multicenter Phase Ⅱ Prospective Clinical Trial of Accelerated Partial Breast Irradiation With IMRT After Breast-conserving Surgery in Early Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03583580
• Other study ID #: NCC201804006
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2017
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2022
• Source: Chinese Academy of Medical Sciences
• Contact: Guangyi Sun, M.D.
• Phone: 08618811100731
• Email: sunliving[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 537
• Est. completion date: June 30, 2024
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

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 ?-?

• 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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Neoplasm Recurrence, Local
• Neoplasms
• Recurrence

Intervention

Radiation:
• Accelerated Partial Breast Irradiation
Patients are irradiated to the region of tumour bed using intensity modulated radiation therapy (IMRT)

Locations

Country	Name	City	State
China	National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	acute and late adverse events assessed by CTCAE v4.0	acute skin toxicity,breast swelling, breast pain,radiation pneumonitis, cardiac toxicity, pulmonary fibrosis, cosmetic result	5 years
Other	quality of life measured with BR-23 questionnaire	BR-23 questionnaire	2 years
Other	the incidence of second malignancy	pathologically diagnosis of contralateral breast cancer and other malignant tumors after radiotherapy	5 year
Primary	locoregional control rate	ipsilateral breast and axilla nodal relapse rate	5 years
Secondary	overall survival	any death	5 years
Secondary	disease-free survival	any recurrence or death	5 years
Secondary	distant-metastasis survival	distant metastasis	5 years