Actively Recruiting
Prospective Study on Exemption of Tumor Bed Boost Radiotherapy for pCR Patients After Breast Conserving Surgery With Neoadjuvant Therapy
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-08-11
150
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, single-arm, phase II clinical trial, aiming to evaluate the safety and efficacy of tumor bed dose escalation radiotherapy for patients with primary breast lesions achieving pCR (ypT0) after neoadjuvant chemotherapy and breast-conserving surgery.
CONDITIONS
Official Title
Prospective Study on Exemption of Tumor Bed Boost Radiotherapy for pCR Patients After Breast Conserving Surgery With Neoadjuvant Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with good compliance and signed informed consent
- Confirmed invasive breast cancer by pathology with baseline breast MR or PET/MR before neoadjuvant therapy
- Received standard neoadjuvant chemotherapy based on molecular subtype
- Single lesion, initially staged cT1-3N0-3a
- Underwent breast-conserving surgery with negative margins (≥1mm) and achieved pCR (ypT0) after neoadjuvant chemotherapy
- Age between 30 and 75 years, ECOG performance status 0-1
- Suitable for adjuvant radiotherapy with normal blood counts, heart, liver, kidney function, and electrocardiogram
- No prior chest radiotherapy
You will not qualify if you...
- Pregnant or breastfeeding women, or women of reproductive potential without contraception
- Known carriers of breast cancer susceptibility gene mutations (BRCA-1, BRCA-2)
- Diagnosed with cT4, N3b-c, bilateral breast cancer, multiple primary lesions, multicentricity, or non-bulky enhancement at primary site
- Did not receive standard neoadjuvant chemotherapy or did not achieve pCR (including ypTis) after neoadjuvant chemotherapy
- Presence of other malignant tumors or participation in other clinical trials
- Unable to start radiotherapy within 8 weeks after surgery
- Presence of distant metastasis at initial diagnosis
- Previous breast cancer history or prior radiotherapy to neck, chest, or ipsilateral axilla
- Severe medical conditions that interfere with radiotherapy
- Uncontrollable neurological or mental disorders causing poor compliance
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated with Nanjing Medical University (Jiangsu Province People's Hospital)
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
X
Xinchen Sun, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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