NCT07164872Not yet recruiting
Neoadjuvant Chemotherapy Combined With Preoperative Radiotherapy for Locally Advanced Breast Cancer
Source: ClinicalTrials.gov · Last updated 10 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Approximately 20% of breast cancer patients in our country are in the locally advanced stage. The relatively low overall survival rate, high recurrence rate and distant metastasis risk of these patients significantly affect the therapeutic efficacy and survival. Preoperative radiotherapy is a treatment option for many tumors. It is recommended to administer radiotherapy and systemic chemotherapy before surgery to enhance preoperative tumor downstaging, eliminate micrometastatic lesions and improve overall survival rate. Preoperative radiotherapy combined with chemotherapy for breast cancer patients further shrinks the tumor, increases the probability of breast preservation, and may also eliminate the need for axillary lymph node dissection, thereby improving the quality of life of patients. Pathological complete response (pCR) not only helps with subsequent surgery but also has significant advantages in improving survival rate. Neoadjuvant radiotherapy is also one of the treatment options for reducing tumor stage, but it has not been widely applied to breast cancer patients. Among breast cancer subtypes, Luminal type accounts for 50-70%, among which HR+ HER2- breast cancer patients have poor efficacy from neoadjuvant chemotherapy and pCR rate is below 5-10%. Triple-negative breast cancer accounts for 15-20% of all breast cancer subtypes. It has the characteristics of poor differentiation, strong invasiveness, earlier and more frequent recurrence and metastasis. The efficacy of traditional neoadjuvant chemotherapy has approached its limit. This study aims to explore the efficacy and safety of neoadjuvant radiotherapy for locally advanced breast cancer.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 7 Aug 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 1 Jul 2030
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07164872
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 1 Oct 2025 to the primary completion date, 1 Jul 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Using immunotherapy drugs such as PD-1/PD-L1
Other illness
- Simultaneous bilateral breast cancer
- History of chest wall radiotherapy
- Active connective tissue disease
- Inflammatory breast cancer
- diabetes
Other
- gestation period
- Excessive breast volume (\>600ml), BMI \> 30
- Positive lymph nodes in the upper and lower regions of the clavicle and the internal mammary region
Who the study is looking for
- The pathological diagnosis was invasive breast cancer.
- cT3-4, cN1-2, M0 (according to the 8th edition of the AJCC Cancer Staging Manual), molecular typing is Luminal type (HER2-) or triple-negative type. The volume of the primary lesion did not decrease by more than 50% after 2 cycles of neoadjuvant chemotherapy.
- Generally in good condition (KPS score \> 70), organ functions are tolerable, and there are no severe complications due to poor control.
- Acceptable for magnetic resonance imaging scan
- Have the conditions for follow-up
- Sign the informed consent form
Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.