Hypofractionated Radiotherapy for Breast Cancer
Hypofractionated Irradiation At Regional Nodal Area for Breast Cancer Vs Existed Standard Treatment
Recruiting
Phase 3
Interventional Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 801 (estimated)
- Sponsor
- Ruijin Hospital · Other
Who this trial is looking for
This trial is looking for women with breast cancer who have had surgery. Participants will receive either a shorter or standard course of radiation therapy to see which is more effective and safe.
Are You a Good Fit for This Trial?
You may be able to join if
- I am between 18 and 75 years old.
- I have been diagnosed with invasive breast cancer.
- I have had breast conservation surgery or a mastectomy.
- I have positive axillary lymph nodes.
- I have a life expectancy of more than 5 years.
- I have a negative surgical margin width of more than 2mm.
- I have a good performance status.
- I can provide written informed consent.
You may not be able to join if
- I have positive supraclavicular lymph nodes or ipsilateral internal mammary nodes.
- I am pregnant or breastfeeding.
- I have severe medical conditions that would prevent radiation treatment.
- I have had another type of cancer in the last 5 years.
- I have simultaneous contralateral breast cancer.
- I have received previous radiation therapy to the chest or surrounding areas.
- I have active collagen vascular disease.
- I have evidence of metastatic disease or advanced cancer.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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About This Trial
The main objective of this trial is to investigate the efficacy and safety of hypofractionated radiotherapy of 3 or 4 weeks by comparing with conventional radiotherapy of 5 or 6 weeks using intensity-modulated radiation therapy (IMRT) in breast cancer patients with an indication for regional nodal irradiation (RNI) following mastectomy or breast conserving surgery. Patients will be randomized to h…
Trial Locations
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Eligibility Criteria
Inclusion criteria :
* Age 18-75 years old
* unilateral histologically confirmed invasive breast carcinoma of pT1-3
* breast conservation surgery or mastectomy
* Breast reconstruction is allowed
* histologically confirmed positive axillary lymph nodes (positive sentinel lymph nodes without axillary…
Contacts