Skip to content

The DANCE-HR Study: DCE-MRI Artificial Intelligence for Neoadjuvant Chemotherapy Benefit Evaluation in HR-positive/HER2-negative Breast Cancer — A Multicenter Prospective Observational Cohort Study

Prediction of Neoadjuvant Chemotherapy Benefit Using a Pre-treatment Breast DCE-MRI-based Artificial Intelligence Model in HR-positive/HER2-negative Breast Cancer Patients: A Multicenter Prospective Observational Cohort Study with Historical Control

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600125942
Enrollment
Unknown
Registered
2026-06-01
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

Breast Cancer

Interventions

Neoadjuvant chemotherapy high benefit group:None

Sponsors

Fujian Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Female patients aged =18 years; 2. Histopathologically confirmed invasive breast cancer; 3. Hormone receptor positive (ER and/or PR =1%); HER2 negative (IHC 0–1+, or IHC 2+ with negative FISH result); 4. Clinical stage cT1–3, cN0–2, M0 (per the 8th edition of AJCC staging system); eligible for neoadjuvant chemotherapy or primary surgery; 5. Completed standard breast MRI before treatment with image quality qualified for model analysis; 6. ECOG performance status 0–1; adequate function of major organs and tolerance to the planned treatment regimen; 7. Voluntary participation with signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. Prior systemic therapy for breast cancer; 2. Inflammatory breast cancer or distant metastasis (M1); 3. Concurrent active malignancies; 4. Contraindications to MRI or unqualified imaging quality; 5. Severe comorbidities precluding chemotherapy or surgery; 6. Any other conditions deemed ineligible by the investigator.

Design outcomes

Primary

MeasureTime frame
RCB0-1;

Secondary

MeasureTime frame
Objective Response Rate;Overall survival;Progression-Free Survival;

Countries

China

Contacts

Public ContactSong Chuangui

Fujian Cancer Hospital

songcg1971@outlook.com+86 139 6070 9993

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026