Hypofractionated PBI After BCS for Low-risk Breast Cancer Patients

NCT ID: NCT03411174

Last Updated: 2025-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2019-07-15

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HF-PBI

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.

Group Type EXPERIMENTAL

hypofractionated partial breast irradiation

Intervention Type RADIATION

deliver 40Gy/15Fx to tumor bed areas

Interventions

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hypofractionated partial breast irradiation

deliver 40Gy/15Fx to tumor bed areas

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Jinli Ma

Associate Professor of department of radiation oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jinli Ma, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Zhang X, Wang X, Xu Z, Chu Y, Chen X, Zhang L, Meng J, Shi W, Yang Z, Mei X, Yu X, Zhang Z, Guo X, Mo M, Liu G, Wu J, Shao Z, Ma J. Hypofractionated partial breast irradiation after breast-conserving surgery for patients with early stage breast cancer in China Mainland: a single-arm prospective trial. Sci Rep. 2025 Jan 31;15(1):3869. doi: 10.1038/s41598-025-88600-5.

Reference Type DERIVED
PMID: 39890895 (View on PubMed)

Other Identifiers

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FDRT-BC003

Identifier Type: -

Identifier Source: org_study_id

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