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NCT07527689: HARVEST-PRO

Ultra-Hypofractionated vs Moderate Hypofractionated Radiotherapy for Regional Lymph Nodes in High Risk Breast Cancer

Not yet recruiting NA Last updated 14 April 2026
What this trial tests

NA trial testing Ultra-hypofractionated Regional Nodal Irradiation in Breast Cancer in 1,950 participants. Not yet recruiting.

Timeline
30 March 2026
Primary endpoint
30 March 2034
30 March 2039

Quick facts

Lead sponsorRuijin Hospital
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment1,950
Start date30 March 2026
Primary completion30 March 2034
Estimated completion30 March 2039
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Ruijin Hospital

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

For patients with breast cancer, regional nodal irradiation (RNI) can significantly reduce the risks of recurrence and mortality. Moderate hypofractionated regimens (40 to 42.5 Gy in 15 to 16 fractions over 3 weeks) is the established standard of care for RNI. Nevertheless, for the majority of patients, a three - week treatment duration is still regarded as lengthy. Although the ultra-hypofractionated regimen (26 Gy in 5 fractions over 1 week) has been proven non-inferior to the moderate hypofractionated regimen for whole breast irradiation, unambiguous evidence supporting its use in comprehensive RNI remains lacking, especially in high risk patients requiring internal mammary node irradiation (IMNI). This prospective, non-inferiority trial is designed to address this evidence gap by evaluating whether a one-week, ultra-hypofractionated regimen (26 Gy in 5 fractions) is non-inferior to the three-week regimen (40 Gy in 15 fractions) for comprehensive RNI, including IMNI.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

Other Ruijin Hospital trials

Trials by the same sponsor.

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Data sources for this page

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