NCT07702708 Pre-Treatment DCE-MRI AI Models Predict Neoadjuvant Chemotherapy Response in HR+/HER2- Breast Cancer
| NCT ID | NCT07702708 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fujian Cancer Hospital |
| Condition | HR+/HER2- Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-06-01 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a multicenter, prospective, observational cohort study to evaluate the predictive performance of pre-treatment DCE-MRI-based artificial intelligence (AI) models for neoadjuvant chemotherapy benefit in HR+/HER2- breast cancer. The study plans to enroll eligible HR+/HER2- breast cancer patients receiving routine standard neoadjuvant chemotherapy and stratify participants into high-benefit and low-benefit subgroups via the established AI model based on baseline breast DCE-MRI images. All enrolled patients will undergo systematic collection of baseline clinical-pathological data, pre-treatment DCE-MRI scans, neoadjuvant chemotherapy regimens, postoperative residual cancer burden (RCB) classification, objective response rate (ORR), and long-term survival endpoints including disease-free survival (DFS) and overall survival (OS). The primary objective compares the rate of RCB 0-1 between AI-defined high-benefit patients and published historical control data; secondary analyses compare ORR, RCB 0-1 proportion, DFS and OS between AI-stratified high-benefit and low-benefit subgroups to comprehensively verify the clinical value of this imaging AI model for individualized neoadjuvant chemotherapy selection.
Eligibility Criteria
Inclusion Criteria: 1. Female patients aged ≥ 18 years old. 2. Histopathologically confirmed invasive breast carcinoma. 3. Hormone receptor positive (ER and/or PR ≥1%), HER2-negative status (IHC 0-1+, or IHC 2+ with negative FISH result). 4. Clinical stage II-III breast cancer per the 8th AJCC staging system, with clinical indication for neoadjuvant chemotherapy or primary surgery. 5. Standard pre-treatment breast DCE-MRI performed before neoadjuvant chemotherapy, with image quality eligible for AI model analysis. 6. ECOG performance status 0 or 1; adequate function of major vital organs to tolerate planned clinical treatment. 7. Voluntary participation with written informed consent obtained. Exclusion Criteria: 1. Prior systemic anti-tumor therapy for breast cancer other than planned neoadjuvant chemotherapy. 2. Inflammatory breast cancer or distant metastatic disease (M1). 3. Concurrent active malignant tumors of other origins. 4. Contraindications to MRI examination or unqualified MRI images that cannot support model analysis. 5. Severe comorbidities incompatible with neoadjuvant chemotherapy or surgical resection. 6. Any other conditions judged ineligible for enrollment by the investigator.
Contact & Investigator
Chuangui Song, doctor
PRINCIPAL INVESTIGATOR
Fujian Cancer Hospital
Frequently Asked Questions
Who can join the NCT07702708 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying HR+/HER2- Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07702708 currently recruiting?
Yes, NCT07702708 is actively recruiting participants. Contact the research team at songcg1971@outlook.com for enrollment information.
Where is the NCT07702708 trial being conducted?
This trial is being conducted at Fuzhou, China, Fuzhou, China, Quanzhou, China, Ningde, China and 1 additional location.
Who is sponsoring the NCT07702708 clinical trial?
NCT07702708 is sponsored by Fujian Cancer Hospital. The principal investigator is Chuangui Song, doctor at Fujian Cancer Hospital. The trial plans to enroll 100 participants.
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