Clinical trial · Interventional
A Randomized Controlled Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined with Systemic Therapy for Early-stage Breast Cancer
NCT06769919CI-TRIAL-00084544not yet recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A total of 340 early-stage breast cancer patients with axillary lymph node biopsy-confirmed positivity were enrolled and divided into two groups. The control group received neoadjuvant systemic therapy followed by surgery and adjuvant radiotherapy. The experimental group received neoadjuvant systemic therapy and neoadjuvant radiotherapy followed by surgery. The treatment response of breast cancer, patient survival time, and treatment safety were subsequently evaluated.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Adjuvant radiotherapy
- description
- receive neoadjuvant systemic therapy, followed by surgery and adjuvant radiotherapy
- type
- EXPERIMENTAL
- label
- Neoadjuvant radiotherapy
- description
- receive neoadjuvant systemic therapy combined with neoadjuvant radiotherapy before undergoing surgery
- interventionNames
- Radiation: Neoadjuvant radiotherapy
Primary outcomes (1)
- measure
- Residual Cancer Burden (RCB) 0/I
- timeFrame
- From enrollment to the end of treatment at 8 weeks
- description
- Residual Cancer Burden (RCB) is a standardized method used to quantify the amount of residual disease in breast cancer patients after neoadjuvant therapy (treatment given before surgery). It is calculated based on the size of the primary tumor, the cellularity of the tumor bed, and the extent of lymph node involvement. RCB is divided into four categories: RCB-0: Pathologic complete response (pCR), meaning no residual invasive cancer is found in the breast or lymph nodes. RCB-I: Minimal residual disease, indicating a very small amount of cancer remains after treatment. RCB-II: Moderate residual disease. RCB-III: Extensive residual disease. RCB-0 and RCB-I are often associated with better prognoses and higher survival rates compared to RCB-II and RCB-III
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients aged ≥18 years and ≤65 years； * newly diagnosed breast cancer; * Axillary lymph node biopsy-positive; * ECOG performance status score of 0-1; Exclusion Criteria: * metastatic breast cancer or bilateral breast cancer; * inflammatory breast cancer; * Pregnancy and Lactation;
References
Publications (0)
Data not yet available
No reference posted for this study.