Breast DiseasesPhase 2NCT07581834
Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multicenter, Prospective Clinical Study
A Phase 2 study testing Dalpiciclib 125mg, Dalpiciclib 100mg and Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen in people with Breast Diseases and Breast Neoplasms, run by Fujian Cancer Hospital at 2 sites in China.
Trial summary
This study is a multicenter, prospective, randomized, open-label clinical study to assess the efficacy and safety of endocrine combined with different doses and treatment duration of darisenatide adjuvant therapy in HR +/HER2- early breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Diseases, Breast Neoplasms, Dalpiciclib
- What is being tested?
- Dalpiciclib 125mg, Dalpiciclib 100mg and Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 2 sitesChina
- Study dates
- 21 Jan 2026to 30 Jun 2032
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female aged 18 years or older with breast cancer who are postmenopausal or premenopausal/perimenopausal.
- Patients with early-stage breast cancer whose HR status is positive and HER2 status is negative, as confirmed by histology (immunohistochemistry showing ER ≥10% and/or PR ≥10%, HER2 0-1+ or HER2 ++ but negative by FISH or CISH testing, with no amplification).
- Patients with histologically confirmed invasive breast cancer at clinical/pathological stages II-III.
- Note: For stage IIA, N1 is required, or N0 with Grade 3 or Grade 2 tumors combined with high-risk factors such as Ki-67 ≥20% or positive genetic testing (including but not limited to high-risk results in the 21-gene test). If the patient has previously received neoadjuvant therapy, the clinical stage at the time before neoadjuvant therapy must meet the above criteria.
- Patients who have previously received or not received neoadjuvant chemotherapy or adjuvant chemotherapy are eligible to enroll.
- The time interval from surgery to enrollment must not exceed 12 months.
- Patients who have received radiotherapy must have recovered from the acute effects of radiotherapy, and there must be at least 14 days of washout period from the end of radiotherapy to enrollment.
- Patients who have previously received chemotherapy must have recovered from the acute adverse effects of chemotherapy before enrollment ([CTCAE] grade ≤1), except for hair loss or grade 2 peripheral neuropathy.There must be a washout period of at least 21 days between the last administration of chemotherapy and enrollment in the study. 8. The Eastern Cooperative Oncology Group performance status score must be 0-1. 9. The functions of major organs must meet the following requirements: a) Blood tests: neutrophils (ANC) ≥1.5×10^9/L; platelet count (PLT) ≥90×10^9/L; hemoglobin (Hb) ≥90 g/L. b) Blood biochemistry tests: total bilirubin (TBIL) ≤2.5×ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×ULN; alkaline phosphatase ≤2.5×ULN; blood urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN. c) 12-lead electrocardiogram: QT interval corrected using the Fridericia method (QTcF) < 470 ms in females (QTcF calculation formula: QTcF = QT/(RR^1/3)). Participants must voluntarily agree to participate in the study, sign the informed consent form, demonstrate good compliance, and be willing to cooperate with follow-up assessments.
Who cannot join
- Stage IV breast cancer or recurrent/metastatic breast cancer, or inflammatory breast cancer;
- A history of any malignant tumor, or previous receipt of anti-tumor therapy or radiotherapy for any malignant tumor, excluding cured cases of cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma, etc.
- Participating in other clinical trials simultaneously;
- Received a blood transfusion within 2 weeks prior to enrollment, or received treatments such as colony-stimulating factors;
- Individuals with a known history of allergy to any component of this medication;
- A history of immunodeficiency, including a positive HIV test result, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
- Any history of heart disease, including: (1) angina pectoris; (2) arrhythmias that require medical treatment or are clinically significant; (3) myocardial infarction; (4) heart failure; (5) any other heart disease deemed by the study investigators to be inappropriate for participation in this trial.
- Pregnant or lactating female patients; 9. Any other circumstances in which the researchers deem the participant unsuitable for participating in this study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 618099
Ting Luo, doctor, 18602866299, tina621@163.com
- Recruiting
Fujian Cancer Hosptial
Fuzhou, Fujian, 350001
Chuangui Song, doctor, 13960709993, songcg1971@outlook.com
About this study
This study is a multicenter, prospective, randomized, open-label clinical study to assess the efficacy and safety of endocrine combined with different doses and treatment duration of darisenatide adjuvant therapy in HR +/HER2- early breast cancer. The study planned to include 2000 HR +/HER2- early breast cancer patients who met the study criteria and were randomized in a 1:1 ratio to Column 1 and Column 2 stratified by nodal status (positive/negative), prior (neo) adjuvant chemotherapy (yes/no), and clinical/pathological stage (Stage II/III).
Cohort 1 received dalcili 125 mg in combination with endocrine therapy for 2 years with dalcili; Cohort 2 received dalcili 100 mg in combination with endocrine therapy for 3 years with dalcili; treatment had to be discontinued until disease progression, intolerable adverse events, withdrawal of consent, or investigator judgment.
- Conditions
- Breast Diseases, Breast Neoplasms, Dalpiciclib, Endocrine Breast Diseases, CDK4/6 Inhibitor, HR+/HER2- Breast Cancer
- Being tested
- Dalpiciclib 125mg, Dalpiciclib 100mg, Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen
- Medical subject headings
- Breast Diseases, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dalpiciclib 125mgDrug
Dalpiciclib: 125 mg, once daily, taken at approximately the same time every day, fasting 1 hour before and after taking the drug, for 21 consecutive days, followed by 7 days off, 28 days as a treatment cycle. It was administered for 2 years.
Dalpiciclib 100mgDrug
Dalpiciclib: 100 mg, once daily, taken at approximately the same time every day, fasting 1 hour before and after taking the drug, for 21 consecutive days, followed by 7 days off, 28 days as a treatment cycle. It was administered for 3 years.
Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifenDrug
Endocrine therapy: endocrine therapy drugs selected by the investigator, including aromatase inhibitors (AIs), fulvestrant, tamoxifen, toremifene, etc.
| Study group | Role | What they receive |
|---|---|---|
| Column 1 | Experimental | Dalpiciclib: 125 mg, once daily, taken at approximately the same time every day, fasting 1 hour before and after taking the drug, for 21 consecutive days, followed by 7 days off, 28 days as a treatment cycle.It was administered for 2 years.
Endocrine therapy: endocrine therapy drugs selected by the investigator, including aromatase inhibitors (AI), fulvestrant, tamoxifen, toremifene, etc. Receives: Drug: Dalpiciclib 125mg; Drug: Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen |
| Column 2 | Experimental | Dalpiciclib: 100 mg, once daily, taken at approximately the same time every day, fasting 1 hour before and after taking the drug, for 21 consecutive days, followed by 7 days off, 28 days as a treatment cycle. It was administered for 3 years.
Endocrine therapy: endocrine therapy drugs selected by the investigator, including aromatase inhibitors (AIs), fulvestrant, tamoxifen, toremifene, etc. Receives: Drug: Dalpiciclib 100mg; Drug: Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year invasive disease-free survival
Defined as the time from the date of enrollment until the first occurrence of one of the following iDFS events: invasive ipsilateral or contralateral recurrent breast cancer, local or regional recurrence, distant metastasis, and death from any cause.
Measured: Observed from enrollment through 3 years.
Secondary outcomes (4)
Distant Disease- Free Survival
From the date of enrollment until the first distant relapse or death from any cause.
Measured: Observed from enrollment through 3 years.
overall survival
Time from enrollment to death from any cause.
Measured: Observed from enrollment through 3 years.
Patient Reported Outcomes
Collected by EORCT QLQ-C30 Quality of Life Scale
Measured: Evaluations are conducted every 3 months in the first year, and every half month in the second and third years.
Safety Results
Record adverse events (AEs) and serious adverse events (SAEs) separately in accordance with the NCI CTC AEv5.0 criteria.
Measured: From the time of enrollment until 30 days after the completion of the medication regimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start21 Jan 2026
- Primary completion31 Dec 2031 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast DiseasesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581834
- Sponsor's protocol ID
- OBU-BC-Ⅱ-304
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 12 May 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 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multicenter, Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07581834
- Acronym / sponsor ID
- OBU-BC-Ⅱ-304
- Conditions
- Breast Diseases, Breast Neoplasms, Dalpiciclib, Endocrine Breast Diseases, CDK4/6 Inhibitor, HR+/HER2- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 12 May 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 multicenter, prospective, randomized, open-label clinical study to assess the efficacy and safety of endocrine combined with different doses and treatment duration of darisenatide adjuvant therapy in HR +/HER2- early breast cancer. The study planned to include 2000 HR +/HER2- early breast cancer patients who met the study criteria and were randomized in a 1:1 ratio to Column 1 and Column 2 stratified by nodal status (positive/negative), prior (neo) adjuvant chemotherapy (yes/no), and clinical/pathological stage (Stage II/III).
Cohort 1 received dalcili 125 mg in combination with endocrine therapy for 2 years with dalcili; Cohort 2 received dalcili 100 mg in combination with endocrine therapy for 3 years with dalcili; treatment had to be discontinued until disease progression, intolerable adverse events, withdrawal of consent, or investigator judgment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Column 1 | Experimental | Drug: Dalpiciclib 125mg, Drug: Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifenDalpiciclib: 125 mg, once daily, taken at approximately the same time every day, fasting 1 hour before and after taking the drug, for 21 consecutive days, followed by 7 days off, 28 days as a treatment cycle.It was administered for 2 years. Endocrine therapy: endocrine therapy drugs selected by the investigator, including aromatase inhibitors (AI), fulvestrant, tamoxifen, toremifene, etc. |
| Column 2 | Experimental | Drug: Dalpiciclib 100mg, Drug: Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifenDalpiciclib: 100 mg, once daily, taken at approximately the same time every day, fasting 1 hour before and after taking the drug, for 21 consecutive days, followed by 7 days off, 28 days as a treatment cycle. It was administered for 3 years. Endocrine therapy: endocrine therapy drugs selected by the investigator, including aromatase inhibitors (AIs), fulvestrant, tamoxifen, toremifene, etc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female aged 18 years or older with breast cancer who are postmenopausal or premenopausal/perimenopausal.
- Patients with early-stage breast cancer whose HR status is positive and HER2 status is negative, as confirmed by histology (immunohistochemistry showing ER ≥10% and/or PR ≥10%, HER2 0-1+ or HER2 ++ but negative by FISH or CISH testing, with no amplification).
- Patients with histologically confirmed invasive breast cancer at clinical/pathological stages II-III.
- Note: For stage IIA, N1 is required, or N0 with Grade 3 or Grade 2 tumors combined with high-risk factors such as Ki-67 ≥20% or positive genetic testing (including but not limited to high-risk results in the 21-gene test). If the patient has previously received neoadjuvant therapy, the clinical stage at the time before neoadjuvant therapy must meet the above criteria.
- Patients who have previously received or not received neoadjuvant chemotherapy or adjuvant chemotherapy are eligible to enroll.
Key exclusion criteria (8 listed)
- Stage IV breast cancer or recurrent/metastatic breast cancer, or inflammatory breast cancer;
- A history of any malignant tumor, or previous receipt of anti-tumor therapy or radiotherapy for any malignant tumor, excluding cured cases of cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma, etc.
- Participating in other clinical trials simultaneously;
- Received a blood transfusion within 2 weeks prior to enrollment, or received treatments such as colony-stimulating factors;
- Individuals with a known history of allergy to any component of this medication;
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 |
|---|---|---|
| Dalpiciclib 125mgDalpiciclib: 125 mg, once daily, taken at approximately the same time every day, fasting 1 hour before and after taking the drug, for 21 consecutive days, followed by 7 days off, 28 days as a treatment cycle. It was administered for 2 years. | Drug | Column 1 |
| Dalpiciclib 100mgDalpiciclib: 100 mg, once daily, taken at approximately the same time every day, fasting 1 hour before and after taking the drug, for 21 consecutive days, followed by 7 days off, 28 days as a treatment cycle. It was administered for 3 years. | Drug | Column 2 |
| Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifenEndocrine therapy: endocrine therapy drugs selected by the investigator, including aromatase inhibitors (AIs), fulvestrant, tamoxifen, toremifene, etc. | Drug | Column 1, Column 2 |
Primary outcome
3-year invasive disease-free survival
Time frame: Observed from enrollment through 3 years.
Defined as the time from the date of enrollment until the first occurrence of one of the following iDFS events: invasive ipsilateral or contralateral recurrent breast cancer, local or regional recurrence, distant metastasis, and death from any cause.
4 secondary outcomes
Distant Disease- Free Survival
Time frame: Observed from enrollment through 3 years.
overall survival
Time frame: Observed from enrollment through 3 years.
Patient Reported Outcomes
Time frame: Evaluations are conducted every 3 months in the first year, and every half month in the second and third years.
Safety Results
Time frame: From the time of enrollment until 30 days after the completion of the medication regimen
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 12 May 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.
2 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 Dalpiciclib 125mg, Dalpiciclib 100mg and Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen in people with Breast Diseases and Breast Neoplasms, run by Fujian Cancer Hospital at 2 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 8 inclusion and 8 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 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
3-year invasive disease-free survival (time frame: Observed from enrollment through 3 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 12 May 2026.