| NCT ID | NCT07814365 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fudan University |
| Condition | Early-Stage Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 818 participants |
| Start Date | 2021-09-16 |
| Primary Completion | 2029-09-16 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 818 participants in total. It began in 2021-09-16 with a primary completion date of 2029-09-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Jinli Ma
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT07814365 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Early-Stage Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07814365 currently recruiting?
Yes, NCT07814365 is actively recruiting participants. Contact the research team at ma-jinli@outlook.com for enrollment information.
Where is the NCT07814365 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07814365 clinical trial?
NCT07814365 is sponsored by Fudan University. The principal investigator is Jinli Ma at Fudan University. The trial plans to enroll 818 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.