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NCT Number: NCT07814365

PBI for Low-risk Breast Cancer

This non-inferiority, phase 3 clinical trial evaluates the cosmetic non-inferiority of a one-week regimen (26 Gy/5 Fx) versus a three-week regimen (40 Gy/15 Fx) using intensity-modulated radiation therapy (IMRT) for partial breast irradiation (PBI) in low-risk breast cancer patients post-breast-conserving surgery. It also compares secondary outcomes including efficacy, safety, and quality of life between the two groups.

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Key information

Conditions

Early-Stage Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location status: Recruiting

Location contact

Xiaofang Wang

CONTACT

[email protected]

+86 18017317247

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female patients with an estimated life expectancy greater than 5 years.
  • Meets criteria for either primary invasive breast cancer or pure ductal carcinoma in situ (DCIS).
  • For invasive breast cancer: Age 40-75 years; Underwent breast-conserving surgery with sentinel lymph node biopsy or axillary lymph node dissection; pT ≤ 3 cm (unicentric/unifocal or total multifocal size ≤ 3 cm); favorable histology (invasive ductal, mucinous, tubular, or solid papillary carcinoma, DCIS component permitted); ER+ and/or PR+; pN0(i- or i+); M0; surgical margins ≥ 2 mm.
  • For pure DCIS: Age 18-75 years; Underwent breast-conserving surgery with or without sentinel lymph node biopsy; low-to-intermediate nuclear grade; tumor size ≤ 2.5 cm; surgical margins ≥ 3 mm.
  • Presence of surgical clips or distinct postoperative seroma/tissue changes in the tumor bed allowing precise target delineation.
  • ECOG performance status 0 or 1.
  • Eligible for systemic therapy, without prior neoadjuvant systemic therapy.
  • Able to tolerate radiotherapy procedures and position immobilization.
  • No contraindications to radiotherapy.
  • Written informed consent provided.

Exclusion criteria

  • Unfavorable histological subtypes (e.g., invasive lobular carcinoma, invasive micropapillary carcinoma).
  • Positive axillary, internal mammary, or supraclavicular lymph nodes.
  • Presence of distant metastasis.
  • Paget's disease of the nipple.
  • History of prior ipsilateral or contralateral invasive breast cancer or DCIS.
  • Bilateral breast cancer.
  • Known germline BRCA1 or BRCA2 mutation.
  • Prior radiotherapy to the ipsilateral breast, chest wall, or regional lymph nodes.
  • Active or prior second malignancy (except adequately treated non-melanoma skin cancer).
  • Severe non-malignant comorbidities (e.g., cardiovascular disease, pulmonary disease, systemic lupus erythematosus, or scleroderma) precluding definitive radiotherapy.
  • Pregnant or lactating patients.
  • Inability or unwillingness to comply with scheduled follow-up visits.

Inability or unwillingness to provide written informed consent.

Treatment and study plan

3-week PBI

Radiation

40.05Gy/15Fx/3w, 2.67Gy/Fx, once daily

1-week PBI

Radiation

26Gy/5Fx/1w, 5.2Gy/Fx, once daily

Primary outcomes

  1. 3-year adverse cosmesis

    Time frame: 3 years

    Adverse cosmetic outcome (defined as 'Fair' or 'Poor') was evaluated by an independent panel using standard photographic assessment based on the EORTC Cosmetic Rating System.

Secondary outcomes

  1. Acute adverse events

    Time frame: 6 months

    The incidence and severity of acute adverse event include radiation dermatitis, pruritus, skin pain, radiation esophagitis, and radiation pneumonitis.

  2. Late adverse events

    Time frame: 3 years

    The incidence and severity of late adverse event include breast induration, skin hyperpigmentation, telangiectasia, breast oedema, and pulmonary fibrosis.

  3. Locoregional recurrence

    Time frame: 5 years

    Locoregional recurrence is defined as the first documented recurrence in the ipsilateral breast or regional nodes.

  4. Distant metastasis

    Time frame: 5 years

    Distant metastasis is the first confirmed recurrence in any distant organ/site beyond the ipsilateral breast and regional nodes.

  5. Overall survival

    Time frame: 5 years

    Overall survival is the time from randomization to death from any cause.

  6. Quality of life (QoL)

    Time frame: 5 years

    Quality of life will be evaluated via standardized QoL scales.

Study contacts

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

Jinli Ma, MD, PhD

CONTACT

[email protected]

(+86)18017312622

Xiaofang Wang, MD, PhD

CONTACT

[email protected]

+86 18017317247

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

A Randomized Phase III Trial Comparing 1-Week vs. 3-Week Partial Breast Irradiation Via IMRT After Breast-Conserving Surgery for Clinical Low-Risk Breast Cancer

Important dates

Study start
2021
Primary completion
2029
Study completion
2031
First posted
Sep 11, 2026
Registry last updated
Sep 11, 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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