HR+/HER2- Breast CancerPhase 2NCT07691333
Kumorixilib Plus Capecitabine and Letrozole for Neoadjuvant Treatment of HR-Positive HER2-Negative Breast Cancer
A Phase 2 study testing Kumorixilib 180mg, Capecitabine 500mg and Letrozole 2.5mg in people with HR+/HER2- Breast Cancer and Breast Neoplasms, run by Fujian Cancer Hospital at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- HR+/HER2- Breast Cancer, Breast Neoplasms
- What is being tested?
- Kumorixilib 180mg, Capecitabine 500mg and Letrozole 2.5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 3 sitesChina
- Study dates
- 30 Jun 2026to 30 Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- Patients who meet all of the following inclusion criteria are eligible for enrollment in this trial:
- 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.
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- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Adequate organ function as defined below: Hematologic function: ① Absolute neutrophil count (ANC) ≥1.5×10⁹/L (no growth factor administered within 14 days prior to screening); ② Platelet count ≥100×10⁹/L (no corrective hematologic therapy within 7 days prior to screening); ③ Hemoglobin ≥100 g/L (no corrective hematologic therapy within 7 days prior to screening).
- Hepatic and renal function: ① Total bilirubin ≤1×upper limit of normal (ULN); ② Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN (ALT and AST ≤5×ULN for patients with liver metastases); ③ Blood urea nitrogen and serum creatinine ≤1.5×ULN, with creatinine clearance ≥50 mL/min (calculated by the Cockcroft-Gault formula).
- Cardiac function on echocardiogram: left ventricular ejection fraction (LVEF) ≥50%. 12-lead electrocardiogram (ECG): QT interval ≤480 ms.
- Able to provide written informed consent prior to any study-related procedures.
Who cannot join
- -
- Patients presenting with any of the following conditions are ineligible for enrollment in this study:
- 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.
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- Breast cancer without histopathological confirmation, or refusal to undergo breast core needle biopsy before or during study treatment.
- History of other malignant tumors within the previous 5 years, except for cured carcinoma in situ of the cervix.
- Severe dysfunction of vital organs including the heart, liver and kidneys.
- Conditions interfering with oral drug intake and absorption, such as inability to swallow, chronic diarrhea, or intestinal obstruction.
- Participation in another interventional clinical trial within 4 weeks prior to enrollment.
- Known hypersensitivity to any components of the study regimen; history of immunodeficiency diseases, including positive human immunodeficiency virus (HIV) test, hepatitis C virus infection, active hepatitis B virus infection, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation.
- Prior diagnosis of any cardiac disease, including clinically significant arrhythmias requiring medical intervention, myocardial infarction, heart failure, or any other cardiac disease judged by the investigator to render the patient unsuitable for trial participation.
- Pregnant or breastfeeding female patients; fertile women with a positive baseline pregnancy test result, or fertile women unwilling to use effective contraception throughout the entire trial period.
- Coexisting severe medical conditions that may compromise patient safety or interfere with study completion as assessed by the investigator, including but not limited to uncontrolled severe hypertension, uncontrolled severe diabetes, active infections, etc.
- Confirmed prior history of neurological or psychiatric disorders, including epilepsy or dementia.
- Any other conditions deemed by the investigator to make the patient unsuitable for participation in this study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Fujian Cancer Hospital
Fuzhou, Fujian, 350001
Chuangui Song, doctor, 13960709993, songcg1971@outlook.com
Fujian Provincial Hospital
Fuzhou, Fujian, 350001
ruijuan Wang, doctor, 13799367490, Rjwang2025@126.com
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, 362000
kaiyan Huang, doctor, 15905059388, kaiyanhuang@fjmu.edu.cn
About this study
Official title: An Exploratory Study to Evaluate the Efficacy and Safety of Kumorixilib Combined With Capecitabine and Letrozole as Neoadjuvant Therapy for HR-Positive, HER2-Negative Breast Cancer
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
- Being tested
- Kumorixilib 180mg, Capecitabine 500mg, Letrozole 2.5mg
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kumorixilib 180mgDrug
Kumorixilib: 180 mg orally once daily. One cycle lasts 28 consecutive days. The total treatment duration is 6 cycles.
Capecitabine 500mgDrug
Capecitabine: 500 mg orally three times daily. One cycle lasts 28 consecutive days. The total treatment duration is 6 cycles.
Letrozole 2.5mgDrug
Letrozole: 2.5 mg orally once daily. One cycle lasts 28 consecutive days. The total treatment duration is 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Kumorixilib + Capecitabine + Letrozole Neoadjuvant Therapy | Experimental | Patients will receive 6 cycles of neoadjuvant treatment. Each cycle lasts 28 days. The regimen is as follows: kumorixilib 180 mg orally once daily, capecitabine 500 mg orally three times daily, and letrozole 2.5 mg orally once daily. After finishing all treatment cycles, patients will undergo breast surgery 2-4 weeks later. Receives: Drug: Kumorixilib 180mg; Drug: Capecitabine 500mg; Drug: Letrozole 2.5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes (5)
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
Measured: At the end of Cycle 1 (each cycle is 28 days)
Reduction rate of functional tumor volume (FTV)
Percentage shrinkage of functional tumor volume measured by breast MRI
Measured: At the end of Cycle 6 (each cycle is 28 days), before breast surgery
Incidence of Residual Cancer Burden (RCB) 0-1
Proportion of patients with RCB grade 0 or 1 on postoperative pathological specimen
Measured: After surgical resection (end of neoadjuvant treatment)
Objective Response Rate (ORR)
Proportion of patients achieving complete response (CR) or partial response (PR) assessed by breast MRI
Measured: At the end of Cycle 6 (each cycle is 28 days), before breast surgery
Treatment-related adverse events
Incidence and severity of all adverse events related to study treatment
Measured: From treatment initiation up to 30 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Jan 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HR+/HER2- Breast CancerStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Chuangui Song, doctor, Principal investigator, Fujian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691333
- Sponsor's protocol ID
- K2026-277-01
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Evaluate the Efficacy and Safety of Kumorixilib Combined With Capecitabine and Letrozole as Neoadjuvant Therapy for HR-Positive, HER2-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT07691333
- Acronym / sponsor ID
- K2026-277-01
- Conditions
- HR+/HER2- Breast Cancer, Breast Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kumorixilib + Capecitabine + Letrozole Neoadjuvant Therapy | Experimental | Drug: Kumorixilib 180mg, Drug: Capecitabine 500mg, Drug: Letrozole 2.5mgPatients will receive 6 cycles of neoadjuvant treatment. Each cycle lasts 28 days. The regimen is as follows: kumorixilib 180 mg orally once daily, capecitabine 500 mg orally three times daily, and letrozole 2.5 mg orally once daily. After finishing all treatment cycles, patients will undergo breast surgery 2-4 weeks later. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- -
- Patients who meet all of the following inclusion criteria are eligible for enrollment in this trial:
- 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.
Key exclusion criteria (17 listed)
- -
- Patients presenting with any of the following conditions are ineligible for enrollment in this study:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kumorixilib 180mgKumorixilib: 180 mg orally once daily. One cycle lasts 28 consecutive days. The total treatment duration is 6 cycles. | Drug | Kumorixilib + Capecitabine + Letrozole Neoadjuvant Therapy |
| Capecitabine 500mgCapecitabine: 500 mg orally three times daily. One cycle lasts 28 consecutive days. The total treatment duration is 6 cycles. | Drug | Kumorixilib + Capecitabine + Letrozole Neoadjuvant Therapy |
| Letrozole 2.5mgLetrozole: 2.5 mg orally once daily. One cycle lasts 28 consecutive days. The total treatment duration is 6 cycles. | Drug | Kumorixilib + Capecitabine + Letrozole Neoadjuvant Therapy |
Primary outcome
Percentage change in Ki-67 score from baseline to Cycle 1 Day 28
Time frame: At the end of Cycle 1 (each cycle is 28 days)
The percentage reduction of Ki-67 proliferation index in tumor tissue between baseline and Cycle 1 Day 28 after treatment initiation.
5 secondary outcomes
Complete cell cycle arrest (CCCA) rate at Cycle 1 Day 28
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Reduction rate of functional tumor volume (FTV)
Time frame: At the end of Cycle 6 (each cycle is 28 days), before breast surgery
Incidence of Residual Cancer Burden (RCB) 0-1
Time frame: After surgical resection (end of neoadjuvant treatment)
Objective Response Rate (ORR)
Time frame: At the end of Cycle 6 (each cycle is 28 days), before breast surgery
Treatment-related adverse events
Time frame: From treatment initiation up to 30 days after the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chuangui Song, doctor principal investigator
Fujian Cancer Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Kumorixilib 180mg, Capecitabine 500mg and Letrozole 2.5mg in people with HR+/HER2- Breast Cancer and Breast Neoplasms, run by Fujian Cancer Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chuangui Song, doctor (13960709993, songcg1971@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in Ki-67 score from baseline to Cycle 1 Day 28 (time frame: At the end of Cycle 1 (each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.