Kumorixilib Plus Capecitabine and Letrozole for Neoadjuvant Treatment of HR-Positive HER2-Negative Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorFujian Cancer Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients with breast cancer aged ≥18 and ≤75 years, satisfying one of the following menopausal status criteria: (1) Bilateral oophorectomy in medical history, or age ≥60 years; (2) Age <60 years with natural menopause (defined as spontaneous cessation of regular menses for at least 12 consecutive months without other pathological or physiological causes), with postmenopausal levels of E2 and FSH; (3) Pre-menopausal or peri-menopausal female patients who are willing to receive LHRH agonist therapy throughout the study period.
Histopathologically confirmed estrogen receptor (ER)-positive (>10%) and/or progesterone receptor (PR)-positive (>10%), HER2-negative breast cancer, assessed in accordance with the 2018 ASCO-CAP guidelines. HER2 negativity is defined as immunohistochemistry (IHC) score of 0+, or IHC 2+ with negative in situ hybridization (ISH) test (ISH amplification ratio <2.0), verified by the pathological laboratory.
Accept core needle biopsy to provide initial tissue samples with Ki-67 ≥10% tested on the initial specimen; agree to provide tissue samples for tumor biomarker testing and peripheral blood samples for biomarker analysis.
Treatment-naïve breast cancer patients staged as Stage II-III per the 8th edition of the AJCC staging system.
Disqualifiers
Prior receipt of any form of anti-tumor therapy (including chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.).
Concurrent administration of other anti-tumor agents.
Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer.
Stage IV breast cancer.
Trial design
Design model
Single group
Treatments tested in this trial
Kumorixilib 180mg
DrugKumorixilib: 180 mg orally once daily. One cycle lasts 28 consecutive days. The total treatment duration is 6 cycles.
Capecitabine 500mg
DrugCapecitabine: 500 mg orally three times daily. One cycle lasts 28 consecutive days. The total treatment duration is 6 cycles.
Letrozole 2.5mg
DrugLetrozole: 2.5 mg orally once daily. One cycle lasts 28 consecutive days. The total treatment duration is 6 cycles.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Kumorixilib + Capecitabine + Letrozole Neoadjuvant TherapyExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Percentage change in Ki-67 score from baseline to Cycle 1 Day 28
The percentage reduction of Ki-67 proliferation index in tumor tissue between baseline and Cycle 1 Day 28 after treatment initiation.
Time frame
At the end of Cycle 1 (each cycle is 28 days)Secondary outcomes
1
Complete cell cycle arrest (CCCA) rate at Cycle 1 Day 28
Proportion of patients with Ki-67 ≤ 2.7% in tumor tissue at Cycle 1 Day 28
Time frame
At the end of Cycle 1 (each cycle is 28 days)2
Reduction rate of functional tumor volume (FTV)
Percentage shrinkage of functional tumor volume measured by breast MRI
Time frame
At the end of Cycle 6 (each cycle is 28 days), before breast surgery3
Incidence of Residual Cancer Burden (RCB) 0-1
Proportion of patients with RCB grade 0 or 1 on postoperative pathological specimen
Time frame
After surgical resection (end of neoadjuvant treatment)4
Objective Response Rate (ORR)
Proportion of patients achieving complete response (CR) or partial response (PR) assessed by breast MRI
Time frame
At the end of Cycle 6 (each cycle is 28 days), before breast surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: