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NCT Number: NCT06984250

Hypofractionated Radiotherapy With Concomitant Tumor Bed Boost for Breast Cancer

Hypofractionated breast radiotherapy with concomitant tumor bed boost for early breast cancer or ductal breast carcinoma in situ after partial mastectomy

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Key information

Conditions

Early Breast Cancer Adenocarcinoma Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Ductal Breast Carcinoma In Situ Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–85 year

Sex eligibility

Female

Study type

Observational

Primary location

National Taiwan University Hospital, Taipei, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Karnofsky Performance Status (KPS) ≥70%
  • Life expectancy ≥ 5 years
  • Adequate renal and hepatic function

Exclusion criteria

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

Treatment and study plan

Hypofractionated Radiation Therapy

Radiation

Hypofractionated breast radiotherapy (HFRT) with hybrid techniques combining field-in-field intensity-modulated RT (FIF-IMRT) to the whole breast with inverse-IMRT for concomitant boost

Other names: Hypofractionated breast radiotherapy with concomitant boost

Primary outcomes

  1. Ipsilateral breast tumor recurrence

    Time frame: From enrollment to the end of treatment at 2 years

    The time from the date of completion of radiotherapy to the date of ipsilateral breast recurrence or death, whichever occurs first. Unit of Measure: Time-to-event (months)

Secondary outcomes

  1. Early Phase Acute Skin Toxicity

    Time frame: Up to 3 months following completion of radiotherapy

    Acute skin toxicity assessed using the Common Terminology Criteria for Adverse Events (CTCAE v5.0), grading severity from Grade 0 (none) to Grade 5 (death). Unit of Measure: CTCAE Grade (0-5)

  2. Late Phase Breast Fibrosis

    Time frame: From 3 months up to 5 years following completion of radiotherapy

    Late breast fibrosis assessed using the Common Terminology Criteria for Adverse Events (CTCAE v5.0), grading severity from Grade 0 (none) to Grade 5 (death). Unit of Measure: CTCAE Grade (0-5)

  3. Patient Quality of Life (EORTC QLQ-C30)

    Time frame: At baseline (before radiotherapy), between 1 week and 1 month following radiotherapy completion, then every 3 to 4 months thereafter until study completion (up to 5 years)

    Quality of life evaluation using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Chinese Mandarin (Taiwan) version. Scores range from 0 to 100, with higher scores indicating better quality of life. Unit of Measure: Score (0-100)

  4. Patient Quality of Life (EORTC QLQ-BR23)

    Time frame: At baseline (before radiotherapy), between 1 week and 1 month following radiotherapy completion, then every 3 to 4 months thereafter until study completion (up to 5 years)

    Quality of life evaluation using the Breast Cancer Module (BR23) of the European Organization for Research and Treatment of Cancer, Chinese Mandarin (Taiwan) version. Scores range from 0 to 100, with higher scores indicating better quality of life. Unit of Measure: Score (0-100)

Study contacts

Contact information is provided by the study sponsor or research team.

Yen-Ting Liu

CONTACT

[email protected]

88697255451

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Acronym: HFCBB

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
May 22, 2025
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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