Comparing neoadjuvant chemoradiotherapy and chemotherapy for advanced breast cancer
Neoadjuvant Chemoradiotherapy Compared to Neoadjuvant Chemotherapy for Luminal-Type Locally Advanced Breast Cancer: A Clinical Study
This study tests whether combining a specific type of radiation with chemotherapy before surgery can help people with advanced breast cancer do better than just using chemotherapy alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sichuan Cancer Hospital and Research Institute Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, cyclophosphamide, doxorubicin |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT06697938 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of preoperative treatment options for luminal-type locally advanced breast cancer by comparing neoadjuvant chemotherapy with neoadjuvant stereotactic body radiotherapy (SBRT) combined with chemotherapy. Utilizing advanced radiotherapy technologies, the study aims to assess outcomes such as the pathological complete response rate, the rate of breast-conserving surgery, progression-free survival, and treatment-related side effects. The goal is to identify new strategic options that could improve treatment outcomes for patients with this type of breast cancer.
Who should consider this trial
Good fit: Ideal candidates include patients with pathologically confirmed invasive luminal-type breast cancer at stages IIB to IIIC who have not received prior treatments.
Not a fit: Patients with inflammatory breast cancer, bilateral or multifocal tumors, or those with a history of other malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide more effective preoperative treatment options that improve surgical outcomes and reduce the need for extensive surgery.
How similar studies have performed: While there have been advancements in neoadjuvant therapies, this specific comparison of SBRT with chemotherapy is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Pathologically confirmed invasive breast cancer ; 2. Breast MRI showing stages IIB to IIIC (2017 AJCC 8th edition staging); 3. Clinical staging confirmed by chest MRI and/or axillary ultrasound, as well as CT scans of the neck, abdomen, and pelvis, and bone scintigraphy, including T and N staging and assessment of distant metastasis; 4. Karnofsky performance score ≥80 or ECOG performance status of 0-1; 5. No history of allergies to doxorubicin, cyclophosphamide, paclitaxel/docetaxel; 6. No prior exposure to radiotherapy, chemotherapy, endocrine therapy, targeted therapy, or immunotherapy. Exclusion Criteria: 1. History of malignancy at other sites, excluding curable non-melanoma skin cancer and carcinoma in situ of the cervix; 2. Inability to complete MRI; 3. Inflammatory breast cancer; 4. Bilateral or multifocal primary tumors; 5. Active infection currently present; clinically evident heart disease; myocardial infarction or cerebrovascular accident within 6 months prior to enrollment.
Where this trial is running
Chengdu, Sichuan
- Sichuan Cancer Hospital — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Principal investigator: Qian Peng, Phd — Sichuan Cancer Hospital and Research Institute
- Study coordinator: Qian Peng, Phd
- Email: pengqian@scszlyy.org.cn
- Phone: 86-028-85420059
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.