Hypofractionated PBI After BCS for Low-risk Breast Cancer Patients

Not Applicable

• Conditions: Breast Cancer
• Interventions: Radiation: hypofractionated partial breast irradiation

• Registration Number: NCT03411174
• Lead Sponsor: Fudan University

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2017-02-20
• Study First Submitted QC: 2018-01-24
• Study First Posted: 2018-01-26
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-04
• Primary Completion: 2019-07
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HF-PBI	hypofractionated partial breast irradiation	Hypofractionated partial breast irradiation was delivered to the tumor bed areas for low recurrence risk breast cancer patients, with prescription dose 40Gy in 15 fractions in 3 weeks.

Primary Outcome Measures

Name	Time	Method
The change of breast cosmetic outcome	Baseline, and three years after the completion of radiation therapy	The breast cosmetic outcome was measured by Harvard 4 scale (poor, moderate, good, excellent) evaluation system

Secondary Outcome Measures

Name	Time	Method
Disease free survival	5 years	The interval from diagnosis to disease recurrence or death or last visit.
Ipsilateral breast tumor recurrence rate	5 years	The pathological confirmed tumor recurrence in the same breast
Late complications	3 years	Complications related to radiation treatment after more than 3 months.
Acute radiation-induced toxicity assessed by CTCAE v4.0	3weeks, 5weeks,1 and 3 months after treatment beginning	acute toxicity related to skin and lung
Local-regional recurrence	5 years	Disease recurrence in the ipsilateral chest wall or axillary, supraclavicular or infraclavicular fossa, or internal mammary chain.
Overall survival	5 years	The interval from diagnosis to death or last visit

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China