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NCT Number: NCT04913532

Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer

Simultaneous integrated boost radiotherapy has been investigated in some malignant tumors and appears to be safe and feasible. However, Hypofractionation with simultaneous integrated boost has been investigating in breast cancer.

Investigators initiated this phase II prospective trial to analyse acute toxicity of hypofractionation with simultaneous integrated boost in patients with early breast cancer.

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Key information

Conditions

Breast Cancer Adjuvant Radiotherapy Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Surgery

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Shijitan Hospital

Beijing, 100038, China

About this study

Hypofractionated radiotherapy of the breast 15 × 2.70 Gy with simultaneous integrated boost to the tumor bed (total dose within the boost volume 15 × 3.20 Gy)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins
  • Indication to adjuvant radiotherapy including boost radiotherapy
  • Clearly identified primary tumor region preferably by radiopaque clips
  • Primary wound healing after breast conserving therapy without signs of infection
  • Pre- and/or postoperative chemotherapy and endocrine therapy were permitted when indicated
  • Written informed consent

Exclusion criteria

  • Patients operated by mastectomy
  • No indication for boost radiation
  • Resection margins positive for disease or insufficient identification of the boost volume
  • Indication for radiotherapy of the regional lymph nodes
  • History of prior breast or thoracic radiotherapy
  • Extended postoperative seroma at the beginning of radiotherapy
  • Psychiatric disorders or psychological disabilities thought to adversely affect treatment compliance
  • Pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception

Treatment and study plan

Hypofractionation with simultaneous integrated boost

Radiation

Hypofractionation with simultaneous integrated boost

Primary outcomes

  1. Acute Toxicity

    Time frame: 6 months

    Acute skin radiogenic toxicity grade II or higher according to NCI-CTCAE

Secondary outcomes

  1. Feasibility of the radiation plan

    Time frame: 19 days

    Dose constraints Dmean lung < 10 Gy; Dmean heart < 5 Gy, Dmedian contralateral breast < 4Gy

  2. other acute Toxicity

    Time frame: 0-6 months

    All dimensions of NCI-CTCAE/RTOG

Other outcomes

  1. Skin toxicity (Cosmetic results)

    Time frame: 0 to 6 months

    RTOG

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

A Phase II Trial of Evaluation of Acute Toxicity in Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Jun 4, 2021
Registry last updated
Jan 23, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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