Randomized Trial of Accelerated Partial Breast Irradiation

Breast Neoplasms Clinical Trial

Official title:

A Phase II Randomized Clinical Trial of Accelerated Partial Breast Irradiation Compared With Whole Breast Irradiation With IMRT in Early Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03583619
• Other study ID #: NCC-000498
• Status: Completed
• Phase: N/A
• Start date: July 19, 2017
• Est. completion date: March 23, 2020

Study information

• Verified date: December 2018
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to compare radiation toxicity of accelerated partial breast irradiation (ABPI) with whole breast irradiation (WBI) in low-risk breast cancer.

Description:

This study is a single-center phase II randomized clinical trial to enroll low-risk breast cancer treat with breast-conserving surgery. All eligible patients are randomized to receive either ABPI (40Gy/10fx/2wks) or WBI(43.5Gy/15fx/3wks). Intensity modulated radiation therapy (IMRT) technique is used. Grade 2 or more acute and late toxicities are prospectively evaluated and compared.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 23, 2020
• Est. primary completion date: January 11, 2019
• 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:
• APBI
Patients receive radiation to the breast tumor bed to a total dose of 40Gy/10fx/2wks, using intensity-modulated radiation therapy technique.
• WBI
Patients receive radiation to the whole breast to a total dose of 43.5Gy/15fx/3wks, using intensity-modulated radiation therapy technique.

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
Primary	Number o participants with Grade 2 or more toxicity	The evaluated toxicities include the following and are evaluated by CTCAE 3.0 criteria: acute skin toxicity,breast swelling, breast pain,radiation pneumonitis, cardiac toxicity, pulmonary fibrosis, cosmetic result	5 years
Secondary	locoregional recurrence	ipsilateral breast and axillary nodal recurrence	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
Secondary	Quality of life measured with BR-23 questionnaire	BR-23 questionnaire	2 years