Hypofractionated Whole-breast Irradiation With Simultaneously Integrated Boost For Early-Stage Breast Cancer After Breast-conserving Surgery

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02617043

Acronym

HF-WBI-SIB

Enrollment

200

Registered

2015-11-30

Start date

2015-04-30

Completion date

2017-12-31

Last updated

2017-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, hypofractionated whole breast irradiation

Brief summary

The study was designed to evaluate the feasibility and safety of hypofractionated whole-breast irradiation with simultaneously integrated boost for early-stage breast cancer after breast conserving surgery in Chinese population.

Interventions

RADIATIONhypofractionated whole breast irradiation with simultaneously integrated boost

deliver 40Gy/15Fx to whole breast with 48Gy/15fx simultaneously integrated to tumor bed

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Female * 18-60 years old * Treated with breast conversing surgery and sentinel lymph node biopsy or axillary lymph node dissection * Pathologically confirmed invasive breast cancer * A pathological T1-2N0M0 tumor * Tumor bed is labeled with Titanium clips * Negative surgical margins * Written informed consent.

Exclusion criteria

* KPS\<70 * Treated with neoadjuvant chemotherapy * Sentinel lymph nodes only containing isolated tumour cells (\<0.2 mm) * With severe comorbidity * Previous breast cancer or other malignant tumor history * Previous radiotherapy for breast or thorax * Medical contraindication for radiotherapy * Pregnant or nursing

Design outcomes

Primary

Measure	Time frame	Description
Numbers of participants with treatment-related toxicity assessed by CTCAE v4.0	2 year	acute toxicity related to irradiation such as lung and skin

Secondary

Measure	Time frame	Description
local-regional recurrence	5 years	—
Disease free survival	5 years	—
acute radiation-induced toxicity assessed by CTCAE v4.0	during radiotherapy; 3months; 6 months	acute toxicity related to skin and lung
Late complications	1,2,3,4,5years	—
cosmetic effect measured by Harvard 4 scale evaluation system	2,3,4,5years	—
Overall survival Over survival	5 years	—

Countries

China

Contacts

Primary ContactXiaoli Yu, MD

stephanieyxl@hotmail.com+86 13817893133

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026