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Prospective Phase II clinical study of preoperative local radiotherapy for breast cancer

Prospective Phase II clinical study of preoperative local radiotherapy for breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097703
Enrollment
Unknown
Registered
2025-02-24
Start date
2025-03-03
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

Group A/Group B:Group A (distance between primary glandular tumor and skin>1cm): Preoperative neoadjuvant local tumor enhanced irradiation with DT10GY/1F/d. Group B (primary breast tumor distance from

Sponsors

Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age >=18 years, <=70 years; 2. ECOG PS < 2; 3. Preoperative puncture pathology confirmed the diagnosis of invasive breast cancer; 4. Stage II-III patients with clinical stage T2-3N0M0 or T1-3N1-2M0 or T1-3N3M0. 5. The patient is scheduled to receive standard neoadjuvant therapy. 6. Breast-conserving or potentially breast-conserving, willing to undergo breast-conserving surgery. 7. No previous history of other malignant tumors, except skin basal cell carcinoma; 8. Informed consent was signed before the study began.

Exclusion criteria

Exclusion criteria: 1. Clear clinical or imaging evidence of metastatic disease; 2. People who do not need neoadjuvant therapy in the early stage; 3. T4: including inflammatory breast cancer; 4. T0: patients with occult breast cancer; 5. No possibility of breast-conserving treatment; 6. Refuse breast-conserving surgery patients; 7. Male breast cancer patients; 8. Complicated with serious heart, lung, liver, kidney, hematopoietic system and nervous system diseases, mental diseases; 9. Previous history of chest radiothe; 10. With scleroderma or active lupus erythematosus and other autoimmune diseases; 11. Pregnant and lactating patients.

Design outcomes

Primary

MeasureTime frame
Incidence of grade 3 short-term incision complications;

Secondary

MeasureTime frame
Cosmetic Results;Pathologic Complete Response,pCR;rates of Local Recurrence,LR;rates of Local Regional Recurrence,LRR;disease free survival,DFS;Overall Survival,OS;Quality of life assessment;Treat toxic side effects;

Countries

China

Contacts

Public ContactXia Zhou

Zhejiang Cancer Hospital

1154389861@qq.com+86 571 88128166

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026