Actively Recruiting

Age: 20Years - 85Years
FEMALE
ID06984250

Hybrid Techniques Combining Hypofractionated Whole Breast Radiotherapy With Concomitant Tumor Bed Boost in Patients With Breast Cancer

Led by National Taiwan University Hospital · Updated on 2025-05-22

315

Participants Needed

2

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying hypofractionated breast radiotherapy with a simultaneous tumor bed boost in women who have early breast cancer or ductal carcinoma in situ after having partial mastectomy surgery. This observational study aims to evaluate this combined radiation approach using hybrid techniques to treat the whole breast and the tumor bed area, with the goal of monitoring tumor recurrence and side effects over time. The treatment involves hypofractionated radiation therapy delivered through advanced methods including field-in-field intensity-modulated radiation therapy (FIF-IMRT) to the whole breast and inverse-IMRT for the boost to the tumor bed. This radiation is given after breast-conserving surgery, focusing on improving targeting while limiting exposure to surrounding tissues. Participants will be monitored from enrollment through at least 2 years for tumor recurrence in the treated breast. Additional assessments include tracking early skin reactions up to 3 months after therapy, long-term breast fibrosis for up to 5 years, and quality of life measured with questionnaires at baseline and regularly until study completion. The study is sponsored by National Taiwan University Hospital and participation lasts up to 5 years with regular follow-up visits.

CONDITIONS

Brief Title

Hypofractionated Radiotherapy With Concomitant Tumor Bed Boost for Breast Cancer

Who Can Participate

Age: 20Years - 85Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients with histologically confirmed early-stage breast cancer (T1-2 and N0-1) or ductal carcinoma in situ (DCIS)
  • Patients undergoing breast-conserving surgery
  • Age 20 years or older
  • Karnofsky Performance Status (KPS) 70% or higher
  • Life expectancy of 5 years or more
  • Adequate kidney and liver function
Not Eligible

You will not qualify if you...

  • Pregnant patients
  • Patients requiring re-irradiation of the thoracic region

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 2 years

Participants receive hypofractionated breast radiotherapy with a concomitant tumor bed boost following partial mastectomy.

Radiotherapy sessions over several weeks as per treatment plan

Follow-up

Duration - Up to 5 years following radiotherapy completion

Participants are monitored for early and late side effects, tumor recurrence, and quality of life for up to 5 years after completion of radiotherapy.

Visits at baseline, between 1 week and 1 month after radiotherapy, then every 3 to 4 months thereafter

Trial Site Locations

Total: 2 locations

1

National Taiwan University Hospital

Taipei, Taiwan, Taiwan, 100

Not Yet Recruiting

2

National Taiwan University Hospital Yunlin Branch

Taipei, Taiwan, 632

Actively Recruiting

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Research Team

Y

Yen-Ting Liu

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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