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NCT Number: NCT05893966

Prospective Cohort for Tumor Bed Boost Radiotherapy in HER2 Positive Breast Cancer

The purpose of this study is to analyze treatment outcomes related to tumor bed boost of postoperative radiation therapy in patient with HER2+ breast cancer who underwent breast conserving surgery.

The main questions it aims to answer are:

* 7-year ipsilateral breast tumor recurrence * 7-year disease-free survival * 7-year locoregional recurrence * 7-year overall survival * Adverse events of radiation therapy

Participants will be assessed by multi-dimensional methods after radiation therapy:

* Assessment for the disease status (disease-free or recurrence) including physical and radiologic examination * Assessment for the adverse events according to CTCAE version 5.0

Recruiting

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female patients with age minimum 19
  • Pathological confirmation of HER2+ invasive breast cancer
  • Eastern Cooperative Oncology Group performance status 0-2
  • Informed consent of the participant

Exclusion criteria

  • Pathological confirmation of ductal carcinoma in situ of the breast
  • Previous history of radiation therapy to ipsilateral breast

Treatment and study plan

Whole breast irradiation +/- tumor bed boost

Radiation

Postoperative whole breast irradiation (3D-conformal radiation therapy or IMRT) with or without tumor bed boost (sequential or simultaneous integrated boost)

Primary outcomes

  1. Ipsilateral breast tumor recurrence

    Time frame: 7 years from the start of the postoperative radiation therapy

    The event for ipsilateral breast tumor recurrence (IBTR) was defined as any breast tumor recurrence in irradiated breast.

Secondary outcomes

  1. Disease-free survival

    Time frame: 7 years from the start of the postoperative radiation therapy

    The event for disease-free survival (DFS) was defined as any local, regional, or distant recurrence or breast cancer-related death.

  2. Locoregional recurrence

    Time frame: 7 years from the start of the postoperative radiation therapy

    The event for locoregional recurrence was defined as recurrence in irradiated breast / chest wall or regional lymph node area.

  3. Overall survival

    Time frame: 7 years from the start of the postoperative radiation therapy

    The event for overall survival (OS) was defined as death of any cause.

  4. Adverse events

    Time frame: 7 years from the start of the postoperative radiation therapy

    Adverse events were evaluated and graded according to CTCAE version 5.0.

Study contacts

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

Haeyoung Kim, MD, PhD

CONTACT

[email protected]

82-2-3410-2612

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Acronym: BOOST-HER2

Important dates

Study start
2022
Primary completion
2030
Study completion
2032
First posted
Jun 8, 2023
Registry last updated
Aug 10, 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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