Breast CancerPhase 2NCT07900516
A Prospective, Phase II, Exploratory Study Protocol of a Chemotherapy Sensitivity-based Culmerciclib Combination Regimen in Neoadjuvant Therapy for HR+/HER2- Breast Cancer.
A Phase 2 study testing Kumoxili, Docetaxel and Epirubicin in people with Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
To explore the efficacy and safety of Culmerciclib combined with chemotherapy as neoadjuvant therapy for HR+/HER2- breast cancer patients who are insensitive to neoadjuvant TAC (docetaxel, doxorubicin, cyclophosphamide) chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Kumoxili, Docetaxel and Epirubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 1 Aug 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
- Initially diagnosed with stage II-III breast cancer according to the AJCC 8th edition staging system.
- Premenopausal or perimenopausal patients (who must receive ovarian function suppression [OFS], including bilateral oophorectomy or GnRHa [GnRH agonists]), or postmenopausal patients.
- Histopathologically confirmed HR+/HER2- breast cancer: estrogen receptor (ER)-positive (>10%), regardless of progesterone receptor (PR) expression level; HER2-negative invasive breast carcinoma as per the 2018 ASCO-CAP HER2-negative interpretation guidelines, confirmed by the pathology laboratory as immunohistochemistry (IHC) 0, 1+, or 2+ with negative in situ hybridization (ISH) (HER2/CEP17 ratio <2.0).
- Female patients aged 18-75 years (inclusive).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥12 weeks.
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- At least one measurable lesion according to RECIST version 1.1.
- Adequate organ function as defined by:
- Hematology: absolute neutrophil count (ANC) >=1.5×10⁹/L; platelet count (PLT) ≥100×10⁹/L; hemoglobin (Hb) >=90 g/L.
- Blood biochemistry: total bilirubin (TBIL) =<1.5× upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =<3×ULN; blood urea nitrogen (BUN) and creatinine (Cr) =<1.5×ULN, and creatinine clearance >=50 mL/min.
- 9.12-lead electrocardiogram (ECG) with QTc interval ≤480 ms. 10.Willing to voluntarily participate, provide written informed consent, and comply with study visits and follow up.
Who cannot join
- Prior receipt of any form of anti tumor therapy (including chemotherapy, radiotherapy, molecularly targeted therapy, endocrine therapy, etc.).
- Concurrent use of other anti tumor drugs.
- Stage IV breast cancer.
- Breast cancer not confirmed by histopathology.
- Other malignancies within the past 5 years, except for cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin.
- Severe dysfunction of vital organs such as heart, liver, or kidneys.
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- Inability to swallow, chronic diarrhea, or intestinal obstruction, or any condition that may affect oral drug absorption.
- Participation in another drug clinical trial within 4 weeks prior to enrollment.
- History of immunodeficiency, including positive HIV test, positive HCV antibodies, active hepatitis B virus infection (HBsAg positive with detectable HBV DNA), or other acquired/congenital immunodeficiency diseases, or history of organ transplantation.
- Known hypersensitivity to any component of the study drugs.
- Any cardiac disease, including: arrhythmia requiring medication or clinically significant; myocardial infarction; heart failure; or any other cardiac condition deemed by the investigator as unsuitable for participation.
- Pregnant or breastfeeding women, or women of childbearing potential with a positive baseline pregnancy test.
- Concurrent medical conditions that, in the investigator's judgment, may compromise patient safety or interfere with study completion (including but not limited to severe hypertension not controlled by medication, severe diabetes, active infections, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
Zhou, 8613814162016, zhouwenbin@njmu.edu.cn
About this study
Official title: A Prospective, Phase II, Exploratory Study Evaluating Neoadjuvant Therapy With a Culmerciclib -Containing Combination Regimen in Patients With HR-Positive, HER2-Negative Breast Cancer Who Are Insensitive to Neoadjuvant TAC (Docetaxel, Doxorubicin, Cyclophosphamide) Chemotherapy.
To explore the efficacy and safety of Culmerciclib combined with chemotherapy as neoadjuvant therapy for HR+/HER2- breast cancer patients who are insensitive to neoadjuvant TAC (docetaxel, doxorubicin, cyclophosphamide) chemotherapy.
- Conditions
- Breast Cancer
- Being tested
- Kumoxili, Docetaxel, Epirubicin, Cyclophosphamide, Letrozole
- Keywords
- HR+/HER2- early breast cancer, Neoadjuvant therapy, Neoadjuvant endocrine therapy, CDK, CDK4/6i
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KumoxiliDrug
Kumoxili 180mg po qd
DocetaxelDrug
Docetaxel 75mg/m2 iv q3w
EpirubicinDrug
Epirubicin 90-100mg/m2 iv q3w
CyclophosphamideDrug
Cyclophosphamide 500mg/m2 iv q3w
LetrozoleDrug
Letrozole 2.5mg po qd
Everolimus (Afinitor®)Drug
Everolimus 5mg po qd
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Culmerciclib Neoadjuvant Therapy for HR+/HER2- Breast Cancer | Experimental | Not described Receives: Drug: Kumoxili; Drug: Docetaxel; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Letrozole; Drug: Everolimus (Afinitor®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective Response Rate
Measured: up to 18 weeks
Secondary outcomes (6)
Change in Ki67 from Baseline to Surgery
Measured: up to 18 weeks
Change in Ki67 from Week 2 to Surgery
Measured: Week 2 to surgery
CCCA
Complete Cell Cycle Arrest
Measured: Day 15 of Cycle 1（each cycle is 28 days)
pCR
Pathologic Complete Response
Measured: At surgery
RCB 0-1
Residual Cancer Burden 0-1
Measured: At surgery
Incidence and Severity of AEs/SAEs
Measured: Informed consent to 30 days post-last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Aug 2026
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Responsible party
- Principal investigator, Wenbin Zhou, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900516
- Sponsor's protocol ID
- KCRT-01
- Status last verified
- Oct 2026
- First submitted
- 5 Aug 2026
- Last updated
- 28 Oct 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Phase II, Exploratory Study Evaluating Neoadjuvant Therapy With a Culmerciclib -Containing Combination Regimen in Patients With HR-Positive, HER2-Negative Breast Cancer Who Are Insensitive to Neoadjuvant TAC (Docetaxel, Doxorubicin, Cyclophosphamide) Chemotherapy.
- ClinicalTrials.gov ID
- NCT07900516
- Acronym / sponsor ID
- KCRT-01
- Conditions
- Breast Cancer
- Keywords
- HR+/HER2- early breast cancer, Neoadjuvant therapy, Neoadjuvant endocrine therapy, CDK, CDK4/6i
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 28 Oct 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.
To explore the efficacy and safety of Culmerciclib combined with chemotherapy as neoadjuvant therapy for HR+/HER2- breast cancer patients who are insensitive to neoadjuvant TAC (docetaxel, doxorubicin, cyclophosphamide) chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adaptive Culmerciclib Neoadjuvant Therapy for HR+/HER2- Breast Cancer | Experimental | Drug: Kumoxili, Drug: Docetaxel, Drug: Epirubicin, Drug: Cyclophosphamide, Drug: Letrozole, Drug: Everolimus (Afinitor®) |
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)
- Initially diagnosed with stage II-III breast cancer according to the AJCC 8th edition staging system.
- Premenopausal or perimenopausal patients (who must receive ovarian function suppression [OFS], including bilateral oophorectomy or GnRHa [GnRH agonists]), or postmenopausal patients.
- Histopathologically confirmed HR+/HER2- breast cancer: estrogen receptor (ER)-positive (>10%), regardless of progesterone receptor (PR) expression level; HER2-negative invasive breast carcinoma as per the 2018 ASCO-CAP HER2-negative interpretation guidelines, confirmed by the pathology laboratory as immunohistochemistry (IHC) 0, 1+, or 2+ with negative in situ hybridization (ISH) (HER2/CEP17 ratio <2.0).
- Female patients aged 18-75 years (inclusive).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (13 listed)
- Prior receipt of any form of anti tumor therapy (including chemotherapy, radiotherapy, molecularly targeted therapy, endocrine therapy, etc.).
- Concurrent use of other anti tumor drugs.
- Stage IV breast cancer.
- Breast cancer not confirmed by histopathology.
- Other malignancies within the past 5 years, except for cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin.
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 |
|---|---|---|
| KumoxiliKumoxili 180mg po qd | Drug | Adaptive Culmerciclib Neoadjuvant Therapy for HR+/HER2- Breast Cancer |
| DocetaxelDocetaxel 75mg/m2 iv q3w | Drug | Adaptive Culmerciclib Neoadjuvant Therapy for HR+/HER2- Breast Cancer |
| EpirubicinEpirubicin 90-100mg/m2 iv q3w | Drug | Adaptive Culmerciclib Neoadjuvant Therapy for HR+/HER2- Breast Cancer |
| CyclophosphamideCyclophosphamide 500mg/m2 iv q3w | Drug | Adaptive Culmerciclib Neoadjuvant Therapy for HR+/HER2- Breast Cancer |
| LetrozoleLetrozole 2.5mg po qd | Drug | Adaptive Culmerciclib Neoadjuvant Therapy for HR+/HER2- Breast Cancer |
| Everolimus (Afinitor®)Everolimus 5mg po qd | Drug | Adaptive Culmerciclib Neoadjuvant Therapy for HR+/HER2- Breast Cancer |
Primary outcome
ORR
Time frame: up to 18 weeks
Objective Response Rate
6 secondary outcomes
Change in Ki67 from Baseline to Surgery
Time frame: up to 18 weeks
Change in Ki67 from Week 2 to Surgery
Time frame: Week 2 to surgery
CCCA
Time frame: Day 15 of Cycle 1（each cycle is 28 days)
pCR
Time frame: At surgery
RCB 0-1
Time frame: At surgery
Incidence and Severity of AEs/SAEs
Time frame: Informed consent to 30 days post-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 28 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Kumoxili, Docetaxel and Epirubicin in people with Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site 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 13 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Wenbi Zhou, Professor (025-68308162, Zhouwenbin@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: up to 18 weeks). 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 28 Oct 2026.