Hypofractionated PBI After BCS for Low-risk Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

Hypofractionated Partial Breast Irradiation After Breast-conserving Surgery for Low-risk Breast Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03411174
• Other study ID #: FDRT-BC003
• Status: Recruiting
• Phase: N/A
• Start date: April 2015
• Est. completion date: December 2019

Study information

• Verified date: January 2019
• Source: Fudan University
• Contact: Jinli Ma, MD,PhD
• Phone: +86 15221033376
• Email: jinli.ma[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study was designed to evaluate the feasibility and safety of hypofractionated partial breast irradiation after breast-conserving surgery for low-risk breast cancer patients.

Description:

A total dose of 40.05Gy in 15 fractions was delivered to the tumor bed for each eligible breast cancer patients. The endpoints including loco-regional recurrence, cosmetic outcomes, and toxicities, were evaluated after treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• Female

• Age= 50 years

• Treated with breast conversing surgery and sentinel lymph node biopsy or axillary lymph node dissection

• Negative surgical margins

• Pathologically confirmed invasive breast cancer

• A pathological T1N0M0 tumor -IHC: ER+/PR+/HER2-

• Tumor bed is labeled with Titanium clips

• Received adjuvant hormonal treatment

• No adjuvant chemotherapy

• ECOG:0-1

• Written informed consent.

Exclusion Criteria:

• Age<50 years

• KPS<70

• Treated with neoadjuvant chemotherapy

• Treated or being treated with chemotherapy

• With severe comorbidity

• Previous breast cancer or other malignant tumor history

• Previous radiotherapy for breast or thorax

• Medical contraindication for radiotherapy

• Pregnant or nursing

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• hypofractionated partial breast irradiation
deliver 40Gy/15Fx to tumor bed areas

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of breast cosmetic outcome	The breast cosmetic outcome was measured by Harvard 4 scale (poor, moderate, good, excellent) evaluation system	Baseline, and three years after the completion of radiation therapy
Secondary	Acute radiation-induced toxicity assessed by CTCAE v4.0	acute toxicity related to skin and lung	3weeks, 5weeks,1 and 3 months after treatment beginning
Secondary	Late complications	Complications related to radiation treatment after more than 3 months.	3 years
Secondary	Ipsilateral breast tumor recurrence rate	The pathological confirmed tumor recurrence in the same breast	5 years
Secondary	Local-regional recurrence	Disease recurrence in the ipsilateral chest wall or axillary, supraclavicular or infraclavicular fossa, or internal mammary chain.	5 years
Secondary	Disease free survival	The interval from diagnosis to disease recurrence or death or last visit.	5 years
Secondary	Overall survival	The interval from diagnosis to death or last visit	5 years