Hypofractionated Radiotherapy With Concomitant Tumor Bed Boost for Breast Cancer

NCT06984250 | Recruiting FDA Device

• 2 other identifiers: 202110027RINB113-S0087
• Study Type: observational
• Target: 315
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Early Breast Cancer; Ductal Breast Carcinoma In Situ

Keywords

breast cancer; concomitant boost; tumor bed; Intensity-modulated radiation therapy; hypofractionated breast radiotherapy

Outcome Measures

Primary Outcomes (1)

• Ipsilateral breast tumor recurrence

  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)

  From enrollment to the end of treatment at 2 years

Secondary Outcomes (4)

• Early Phase Acute Skin Toxicity

  Up to 3 months following completion of radiotherapy

• Late Phase Breast Fibrosis

  From 3 months up to 5 years following completion of radiotherapy

• Patient Quality of Life (EORTC QLQ-C30)

  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)

• Patient Quality of Life (EORTC QLQ-BR23)

  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)

Study Arms (1)

CBB

Hypofractionated breast radiotherapy following partial mastectomy in patients with early breast cancer or ductal breast carcinoma in situ

Radiation: Hypofractionated Radiation Therapy

Interventions

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

Also known as: Hypofractionated breast radiotherapy with concomitant boost

CBB

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female patients diagnosed with early-stage breast cancer (T1-2 and N0-1) or ductal carcinoma in situ (DCIS) who are undergoing breast-conserving surgery.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (2)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

NOT YET RECRUITING

National Taiwan University Hospital Yunlin Branch

Taipei, 632, Taiwan

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yen-Ting Liu

CONTACT

88697255451; nickliucool@ntuh.gov.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 22, 2025
• Study Start: February 6, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2030
• Last Updated: May 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

TW (2)