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Axillary Lymph Node Count Predicts Pathologic Complete Response to Neoadjuvant Therapy in ER+/HER2- Breast Cancer: A Single-Center Retrospective Study

Axillary Lymph Node Count Predicts Pathologic Complete Response to Neoadjuvant Therapy in ER+/HER2- Breast Cancer: A Single-Center Retrospective Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600127684
Enrollment
Unknown
Registered
2026-07-06
Start date
2026-07-10
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

ER-positive/HER2-negative breast cancer

Interventions

observation group:None

Sponsors

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age 18 or older, female; 2. Pathologically confirmed invasive breast cancer through core needle biopsy (including invasive ductal carcinoma, invasive lobular carcinoma, and other special types); 3. Received a full course of neoadjuvant chemotherapy (= 4 cycles of an anthracycline- and/or taxane-based regimen); 4. Underwent modified radical mastectomy or breast-conserving surgery with axillary lymph node dissection (ALND) after neoadjuvant chemotherapy; 5. Have a complete surgical pathology report, including total number of axillary lymph nodes examined, number of metastatic lymph nodes, MP grading or residual cancer burden (RCB) assessment, ypN staging; 6. Have Ki-67 immunohistochemistry results before neoadjuvant treatment.

Exclusion criteria

Exclusion criteria: 1. Inflammatory breast cancer (T4d); 2. Newly diagnosed stage IV (M1) breast cancer; 3. Patients who had a sentinel lymph node biopsy (SLNB) before neoadjuvant chemotherapy but did not complete ALND afterwards; 4. Patients who received radiotherapy during neoadjuvant chemotherapy; 5. Patients whose preoperative biopsy showed ER- or Her- tumors; 6. Synchronous bilateral breast cancer; 7. History of previous malignancy; 8. Key variables (total lymph nodes, Ki-67, MP grade, ypN) missing and cannot be supplemented.

Design outcomes

Primary

MeasureTime frame
total pathological complete response, pCR;total lymph node yield, TLNY;

Countries

China

Contacts

Public ContactWenjie Lv

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

lvwenjie_2021@163.com+86 21 2507 7935

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026