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Completed

NCT Number: NCT03411174

Hypofractionated PBI After BCS for Low-risk Breast Cancer Patients

The study was designed to evaluate the feasibility and safety of hypofractionated partial breast irradiation after breast-conserving surgery for low-risk breast cancer patients.

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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

50 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

About this study

A total dose of 40.05Gy in 15 fractions was delivered to the tumor bed for each eligible breast cancer patients. The endpoints including loco-regional recurrence, cosmetic outcomes, and toxicities, were evaluated after treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female
  • Age≥ 50 years
  • Treated with breast conversing surgery and sentinel lymph node biopsy or axillary lymph node dissection
  • Negative surgical margins
  • Pathologically confirmed invasive breast cancer
  • A pathological T1N0M0 tumor -IHC: ER+/PR+/HER2-
  • Tumor bed is labeled with Titanium clips
  • Received adjuvant hormonal treatment
  • No adjuvant chemotherapy
  • ECOG:0-1
  • Written informed consent.

Exclusion criteria

  • Age<50 years
  • KPS<70
  • Treated with neoadjuvant chemotherapy
  • Treated or being treated with chemotherapy
  • With severe comorbidity
  • Previous breast cancer or other malignant tumor history
  • Previous radiotherapy for breast or thorax
  • Medical contraindication for radiotherapy
  • Pregnant or nursing

Treatment and study plan

hypofractionated partial breast irradiation

Radiation

deliver 40Gy/15Fx to tumor bed areas

Primary outcomes

  1. The change of breast cosmetic outcome

    Time frame: Baseline, and three years after the completion of radiation therapy

    The breast cosmetic outcome was measured by Harvard 4 scale (poor, moderate, good, excellent) evaluation system

Secondary outcomes

  1. Acute radiation-induced toxicity assessed by CTCAE v4.0

    Time frame: 3weeks, 5weeks,1 and 3 months after treatment beginning

    acute toxicity related to skin and lung

  2. Late complications

    Time frame: 3 years

    Complications related to radiation treatment after more than 3 months.

  3. Ipsilateral breast tumor recurrence rate

    Time frame: 5 years

    The pathological confirmed tumor recurrence in the same breast

  4. Local-regional recurrence

    Time frame: 5 years

    Disease recurrence in the ipsilateral chest wall or axillary, supraclavicular or infraclavicular fossa, or internal mammary chain.

  5. Disease free survival

    Time frame: 5 years

    The interval from diagnosis to disease recurrence or death or last visit.

  6. Overall survival

    Time frame: 5 years

    The interval from diagnosis to death or last visit

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Hypofractionated Partial Breast Irradiation After Breast-conserving Surgery for Low-risk Breast Cancer Patients

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jan 26, 2018
Registry last updated
May 13, 2025

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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