Health TrialsbyHealthPanel

1-Week Versus 3-Week PBI

ConditionEarly-Stage Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorFudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

818 Participants
are divided into 2 treatment groups
Group A: arm 1Experimental treatment 1 intervention
Group B: arm 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Adverse cosmesis

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.

Time frame
3 years

Secondary outcomes

1

Rate of locoregional recurrence

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

Time frame
5 years
2

Overall survival

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

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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