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Clinical Trial NCT06568705 for Breast Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Hypofractionated Online Adaptive Radiotherapy of Breast Cancer Phase 2 40 Adaptive Design

Recruiting
Clinical Trial NCT06568705 is designed to study Treatment for Breast Cancer. It is a Phase 2 interventional study that is recruiting, having started on September 1, 2024, with plans to enroll 40 participants. Led by Peking Union Medical College Hospital, it is expected to complete by December 1, 2026. The latest data from ClinicalTrials.gov was last updated on March 20, 2026.
Brief Summary

The goal of this clinical trial is to explore the application of online adaptive radiotherapy in patients who receive moderate hypofractionated or ultrafractionated radiotherapy after breast cancer surgery. The main questions it aims to answer are:

  • Can online adaptive radiotherapy improve the accuracy of dose delivery?
  • In patients undergoing online adaptive radiotherapy, how are the treatment-related toxicities ...
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Detailed Description
Online Adaptive Radiotherapy (ART) is an evolution of image-guided radiotherapy that compresses the entire process of image acquisition, plan design, verification, and radiation delivery into approximately 10-30 minutes during which patients do not need to leave the treatment bed. Online ART features rapid image acquisition, automatic contouring and plan optimization supported by artificial intelligence. Body positio...Show More
Official Title

Hypofractionated Online Adaptive Radiotherapy of Breast Cancer

Conditions
Breast Cancer
Other Study IDs
  • HF_BCoART
NCT ID Number
NCT06568705
Start Date (Actual)
2024-09-01
Last Update Posted
2026-03-20
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
40
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
Online Adaptive Radiotherapy
Breast Cancer
Hypofractionated Radiotherapy
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Experimental26Gy/5f online adaptive radiotherapy
The CTV receives a dose of 26Gy in 5 fractions by online adaptive radiotherapy.
Ultrafractionated Radiation Treatment
The online adaptive radiotherapy workflow is used to deliver radiation dose. The CTV of ipsilateral breast receives a dose of 26Gy in 5 fractions in patients who underwent breast conserving surgery or mastectomy.
Active Comparator43.5Gy/15f online adaptive radiotherapy
The CTV receives a dose of 43.5Gy in 15 fractions by online adaptive radiotherapy.
Moderate hypofractionated Radiation Treatment
The online adaptive radiotherapy workflow is used to deliver radiation dose. The CTV of ipsilateral breast receives a dose of 43.5Gy in 15 fractions in patients who underwent breast conserving surgery or mastectomy.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
The dose coverage of target volume as assessed by planning tumor volume V100%
Planning tumor volume V100%, defined as the planning tumor volume receiving at least 100% of the prescribed dose (V100%), is used to evaluate the dose coverage of target volume.
3 months after radiotherapy
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Treatment-related toxicity
Toxicity is evaluated by Common Terminology Criteria for Adverse Events v5.0.
Baseline; Every week during radiotherapy; 1 week, 2 weeks, 3/6/12/24 months after radiotherapy.
Local recurrence rate (LRR)
LRR will be deducted from the local recurrence survival defined as the interval between date of surgery and the occurrence of local relapse.
3, 6, 12, 24 months after radiotherapy
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
35 Years
Eligible Sexes
Female
  • Female, aged ≥35 years, <70 years
  • ECOG score: 0-2
  • Having underwent breast-conserving surgery or Modified radical mastectomy with or without sentinel lymph node biopsy or axillary lymph node dissection
  • Pathologically confirmed primary breast cancer
  • For patients who did not receive neoadjuvant therapy: pathological staged pT0-2N0-1; for patients who received neoadjuvant therapy: staged ypT0-2N0-1
  • Indicated for postoperative adjuvant radiotherapy, planned to undergo postoperative adjuvant radiotherapy
  • Able to cooperate and tolerate the treatment

  • Pathologically confirmed metastasis in supraclavicular or infraclavicular lymph nodes, or distant metastasis
  • History of radiotherapy to the neck or chest
  • Contraindications or intolerance to radiation therapy (such as pregnancy or lactation, severe impairment of heart, lung, kidney, liver, or other vital organ functions; severe infection or hematologic abnormalities; brachial plexus nerve injury on the affected side; active connective tissue diseases, etc.)
  • History of malignant tumors
Peking Union Medical College Hospital logoPeking Union Medical College Hospital482 active studies to explore
Study Central Contact
Contact: Xiaorong Hou, MD, +86-13811963013, [email protected]
Contact: Xiaorong Hou, +86-13811963013, [email protected]
1 Study Locations in 1 Countries
Peking Union Medical College Hospital, Beijing, China
Xiaorong Hou, MD, Contact, +86-13811963013, [email protected]
Recruiting