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Kumorixilib Plus Capecitabine and Letrozole for Neoadjuvant Treatment of HR-Positive HER2-Negative Breast Cancer

NCT07691333 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-07-08

No results posted yet for this study

Summary

This study is a single-center, prospective, open-label exploratory clinical study to assess the efficacy and safety of kumorixilib combined with capecitabine and letrozole as neoadjuvant therapy in patients with HR+/HER2- stage II-III invasive breast cancer. The study plans to enroll 35 eligible patients, and all participants will receive the triple-drug combination regimen without randomization. The treatment regimen: kumorixilib 180 mg orally once daily, capecitabine 500 mg orally three times daily, and letrozole 2.5 mg orally once daily; each cycle lasts 28 days, for a total of 6 cycles. Breast MRI will be used to evaluate radiological tumor response. Surgical resection will be arranged 2-4 weeks after neoadjuvant treatment ends. The primary endpoint is the percentage change in Ki-67 score from baseline to Cycle 1 Day 28. Secondary endpoints include the complete cell cycle arrest rate (CCCA, Ki-67 ≤ 2.7%) on Day 28, the reduction rate of functional tumor volume (FTV), the proportion of patients with RCB 0-1, objective response rate (ORR), and treatment safety. Treatment will be discontinued upon disease progression, intolerable adverse events, withdrawal of consent, or investigator judgment.

Conditions

  • HR+/HER2- Breast Cancer
  • Breast Neoplasms

Interventions

DRUG

Kumorixilib 180mg

Kumorixilib: 180 mg orally once daily. One cycle lasts 28 consecutive days. The total treatment duration is 6 cycles.

DRUG

Capecitabine 500mg

Capecitabine: 500 mg orally three times daily. One cycle lasts 28 consecutive days. The total treatment duration is 6 cycles.

DRUG

Letrozole 2.5mg

Letrozole: 2.5 mg orally once daily. One cycle lasts 28 consecutive days. The total treatment duration is 6 cycles.

Sponsors & Collaborators

  • Fujian Cancer Hospital

    lead OTHER_GOV

Principal Investigators

  • Chuangui Song, doctor · Fujian Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-01-30
Completion
2028-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07691333 on ClinicalTrials.gov