Breast CancerPhase 2NCT07666555
A Phase II Clinical Study of the Efficacy and Safety of Culmerciclib Rechallenge in HR-positive, HER2-negative Breast Cancer Patients With Resistance to First-line Endocrine Therapy.
A Phase 2 study testing CDK4/6 inhibitor, Culmerciclib and Fulvestrant in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
To evaluate the efficacy and safety of Culmerciclib combined with fulvestrant compared with investigator-selected CDK4/6 inhibitors combined with fulvestrant in patients with HR-positive/HER2-negative breast cancer who have progressed after first-line endocrine therapy 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?
- CDK4/6 inhibitor, Culmerciclib and Fulvestrant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2026to 30 Dec 2029
- 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
- 1) Female, ≥18 years old; ≤ 75years old 2)ECOG score 0-2; 3) Predicted survival ≥3 months;Patients with locally advanced and/or metastatic breast cancer confirmed by histopathology with positive ER expression and negative HER2 expression; 5) Enrolled subjects must meet one of the following criteria regarding prior endocrine therapy: i) Received CDK4/6 inhibitor combined with endocrine therapy as adjuvant endocrine therapy, experienced recurrence or progression during or within 1 year after completion of adjuvant CDK4/6 inhibitor therapy, and did not receive subsequent endocrine therapy; ii) Recurrence or progression more than 1 year after completion of adjuvant endocrine monotherapy, followed by progression after receiving CDK4/6 inhibitor combined with endocrine therapy as first-line salvage endocrine therapy; iii) Newly diagnosed locally advanced or metastatic disease, with disease progression after receiving CDK4/6 inhibitor combined with endocrine therapy as first-line salvage endocrine therapy; 6)Participants with recurrent or metastatic disease may receive rescue chemotherapy, ADC, or rescue endocrine therapy not exceeding first-line treatment; 7) The time interval between non-endocrine therapy should be ≥2 weeks; 8) At least one extracranial measurable lesion as defined by RECIST V1.1 criteria; 9) The functions of vital organs meet the requirements; 10) Fertile subjects must have a negative pregnancy test 7 days before starting treatment and must use an appropriate contraceptive method during treatment and for three months after completion of treatment; 11) The patient is fully informed and voluntarily signs the informed consent.
Who cannot join
- 1) Previously diagnosed with HER2-positive breast cancer based on pathological testing; ; 2) Known allergy to the tested drug component; 3) inflammatory breast cancer at the time of screening; 4) pia meningeal metastasis confirmed by MRI or lumbar puncture; 5) Central nervous system metastasis confirmed by imaging; 6) To the best of the investigator's judgment, symptomatic visceral disease or any disease load or none is considered optimal Endocrine therapy options are not suitable for endocrine therapy; 7) Inability or unwillingness to swallow medication or receive intramuscular injections; 8) Gastrointestinal insufficiency or gastrointestinal disease (if not controlled) that may significantly affect study drug absorption Ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small intestine resection, etc.; 9) Patients with ascites, pleural effusion and pericardial effusion accompanied by clinical symptoms in the baseline period need drainage, or use it for the first time Patients with serous cavity drainage within 4 weeks before medication; 10) A history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency conditions, Or have a history of organ transplantation; 11) Other malignancies (cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and Thyroid cancer is excluded); 12) had undergone major surgical procedures or significant trauma within 4 weeks prior to the start of treatment, or was expected to undergo major surgery Surgical treatment; 13) Concomitant diseases that, in the investigator's judgment, seriously endanger patient safety or interfere with patient completion of the study (e.g.
- Severe hypertension, diabetes, thyroid disease, co-active hepatitis B/C, and other activities Sexual infection); 14) Inability to understand or follow research instructions and requirements; 15) The researcher decides that it is not suitable to participate in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase II Clinical Trial Evaluating the Efficacy and Safety of Culmerciclib Combined With Fulvestrant Compared to an Investigator-Selected CDK4/6 Inhibitor Combined With Fulvestrant in Patients With HR-Positive, HER2-Negative Breast Cancer Who Have Progressed After First-Line Endocrine Therapy
To evaluate the efficacy and safety of Culmerciclib combined with fulvestrant compared with investigator-selected CDK4/6 inhibitors combined with fulvestrant in patients with HR-positive/HER2-negative breast cancer who have progressed after first-line endocrine therapy
Read the detailed description
The study was a Randomized, open-label, multicenter design. Patients with dvanced HR+/HER2- breast cancer who had failed previous adjuvant treatment with CDK4/6 inhibitors in combination with endocrine therapy were treated with fulvestrant and Culmerciclib
- Conditions
- Breast Cancer
- Being tested
- CDK4/6 inhibitor, Culmerciclib, Fulvestrant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDK4/6 inhibitorDrug
investigator's choice of CDK4/6 inhibitor
CulmerciclibDrug
CDK2/4/6 inhibitor
FulvestrantDrug
Fulvestrant
| Study group | Role | What they receive |
|---|---|---|
| Culmerciclib combined with fulvestrant | Experimental | Culmerciclib combined with fulvestrant Receives: Drug: Culmerciclib; Drug: Fulvestrant |
| investigator's choice of CDK4/6 inhibitor combined with fulvestrant | Active comparator | investigator's choice of CDK4/6 inhibitor combined with fulvestrant Receives: Drug: CDK4/6 inhibitor; Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
time to progressive disease (according to RECIST1.1)
Measured: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 1 years)
Secondary outcomes (3)
ORR
The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
Measured: max 6 months
DOR
Duration of Overall Response.The date of the first assessed PR/CR (according to RECIST 1.1) to the date of the first assessed tumor progression (according to RECIST 1.1) or death from any cause.
Measured: max 6 months
OS
ime from randomization (or start of treatment) to death from any cause
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start6 Jun 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Dec 2029 (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.
- More trials run by Fudan UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666555
- Sponsor's protocol ID
- RISE
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial Evaluating the Efficacy and Safety of Culmerciclib Combined With Fulvestrant Compared to an Investigator-Selected CDK4/6 Inhibitor Combined With Fulvestrant in Patients With HR-Positive, HER2-Negative Breast Cancer Who Have Progressed After First-Line Endocrine Therapy
- ClinicalTrials.gov ID
- NCT07666555
- Acronym / sponsor ID
- RISE
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 6 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 24 Jun 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 evaluate the efficacy and safety of Culmerciclib combined with fulvestrant compared with investigator-selected CDK4/6 inhibitors combined with fulvestrant in patients with HR-positive/HER2-negative breast cancer who have progressed after first-line endocrine therapy
Detailed description
The study was a Randomized, open-label, multicenter design. Patients with dvanced HR+/HER2- breast cancer who had failed previous adjuvant treatment with CDK4/6 inhibitors in combination with endocrine therapy were treated with fulvestrant and Culmerciclib
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culmerciclib combined with fulvestrant | Experimental | Drug: Culmerciclib, Drug: FulvestrantCulmerciclib combined with fulvestrant |
| investigator's choice of CDK4/6 inhibitor combined with fulvestrant | Active comparator | Drug: CDK4/6 inhibitor, Drug: Fulvestrantinvestigator's choice of CDK4/6 inhibitor combined with fulvestrant |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Female, ≥18 years old; ≤ 75years old 2)ECOG score 0-2; 3) Predicted survival ≥3 months;Patients with locally advanced and/or metastatic breast cancer confirmed by histopathology with positive ER expression and negative HER2 expression; 5) Enrolled subjects must meet one of the following criteria regarding prior endocrine therapy: i) Received CDK4/6 inhibitor combined with endocrine therapy as adjuvant endocrine therapy, experienced recurrence or progression during or within 1 year after completion of adjuvant CDK4/6 inhibitor therapy, and did not receive subsequent endocrine therapy; ii) Recurrence or progression more than 1 year after completion of adjuvant endocrine monotherapy, followed by progression after receiving CDK4/6 inhibitor combined with endocrine therapy as first-line salvage endocrine therapy; iii) Newly diagnosed locally advanced or metastatic disease, with disease progression after receiving CDK4/6 inhibitor combined with endocrine therapy as first-line salvage endocrine therapy; 6)Participants with recurrent or metastatic disease may receive rescue chemotherapy, ADC, or rescue endocrine therapy not exceeding first-line treatment; 7) The time interval between non-endocrine therapy should be ≥2 weeks; 8) At least one extracranial measurable lesion as defined by RECIST V1.1 criteria; 9) The functions of vital organs meet the requirements; 10) Fertile subjects must have a negative pregnancy test 7 days before starting treatment and must use an appropriate contraceptive method during treatment and for three months after completion of treatment; 11) The patient is fully informed and voluntarily signs the informed consent.
Key exclusion criteria (2 listed)
- 1) Previously diagnosed with HER2-positive breast cancer based on pathological testing; ; 2) Known allergy to the tested drug component; 3) inflammatory breast cancer at the time of screening; 4) pia meningeal metastasis confirmed by MRI or lumbar puncture; 5) Central nervous system metastasis confirmed by imaging; 6) To the best of the investigator's judgment, symptomatic visceral disease or any disease load or none is considered optimal Endocrine therapy options are not suitable for endocrine therapy; 7) Inability or unwillingness to swallow medication or receive intramuscular injections; 8) Gastrointestinal insufficiency or gastrointestinal disease (if not controlled) that may significantly affect study drug absorption Ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small intestine resection, etc.; 9) Patients with ascites, pleural effusion and pericardial effusion accompanied by clinical symptoms in the baseline period need drainage, or use it for the first time Patients with serous cavity drainage within 4 weeks before medication; 10) A history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency conditions, Or have a history of organ transplantation; 11) Other malignancies (cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and Thyroid cancer is excluded); 12) had undergone major surgical procedures or significant trauma within 4 weeks prior to the start of treatment, or was expected to undergo major surgery Surgical treatment; 13) Concomitant diseases that, in the investigator's judgment, seriously endanger patient safety or interfere with patient completion of the study (e.g.
- Severe hypertension, diabetes, thyroid disease, co-active hepatitis B/C, and other activities Sexual infection); 14) Inability to understand or follow research instructions and requirements; 15) The researcher decides that it is not suitable to participate in this study
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 |
|---|---|---|
| CDK4/6 inhibitorinvestigator's choice of CDK4/6 inhibitor | Drug | investigator's choice of CDK4/6 inhibitor combined with fulvestrant |
| CulmerciclibCDK2/4/6 inhibitor | Drug | Culmerciclib combined with fulvestrant |
| FulvestrantFulvestrant | Drug | Culmerciclib combined with fulvestrant, investigator's choice of CDK4/6 inhibitor combined with fulvestrant |
Primary outcome
PFS
Time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 1 years)
time to progressive disease (according to RECIST1.1)
3 secondary outcomes
ORR
Time frame: max 6 months
DOR
Time frame: max 6 months
OS
Time frame: 5 years
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 24 Jun 2026.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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 CDK4/6 inhibitor, Culmerciclib and Fulvestrant in people with Breast Cancer, run by Fudan 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 1 inclusion and 2 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 24 Jun 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 Zhimin Shao Professor (08664175590 ext. 8880, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 1 years)). 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 24 Jun 2026.