Early Breast CancerPhase 2NCT07101159
Dalpiciclib as Adjuvant Therapy for HR-positive/HER2-negative Early-stage Patients
A Phase 2 study testing Dalpiciclib and Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) in people with Early Breast Cancer and Adjuvant Therapy, run by Fujian Cancer Hospital.
Trial summary
This study aims to evaluate the efficacy and safety of adjuvant endocrine therapy combined with dalpiciclib at different doses and durations in patients with hormone receptor (HR)-positive, HER2-negative early-stage breast cancer. It is a multicenter, prospective clinical study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early Breast Cancer, Adjuvant Therapy, Hormone Receptor Positive / HER2-negative Breast Cancer
- What is being tested?
- Dalpiciclib and Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Dec 2031
- 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 breast cancer patients aged ≥ 18 years, who are postmenopausal or premenopausal/perimenopausal;
- Histologically confirmed HR-positive, HER2-negative early-stage breast cancer (immunohistochemical detection shows ER ≥ 10% and/or PR ≥ 10%, HER2 0-1+ or HER2 ++ but negative and non-amplified by FISH or CISH detection);
- Histologically confirmed invasive breast cancer with postoperative pathological stage II-III;
- Patients with or without prior neoadjuvant chemotherapy or adjuvant chemotherapy are eligible for enrollment;
- The maximum time from surgery to enrollment does not exceed 12 months;
- Patients receiving radiotherapy must have recovered from acute radiation reactions, with a washout period of at least 14 days from the end of radiotherapy to enrollment;
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- Patients who received previous chemotherapy must have recovered from acute adverse reactions of chemotherapy (graded ≤ 1 according to [CTCAE]) before enrollment, except for alopecia or grade 2 peripheral neuropathy. There must be a washout period of at least 21 days from the last chemotherapy administration to enrollment;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- The main organ function levels must meet the following requirements: Blood routine: Neutrophil count (ANC) ≥ 1.5×10⁹/L; Platelet count (PLT) ≥ 90×10⁹/L; Hemoglobin (Hb) ≥ 90 g/L;Blood biochemistry: 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;
- 12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) < 470 ms in females (QTcF calculation formula: QTcF = QT/(RR^1/3));
- Voluntarily participate in this study, sign the informed consent, have good compliance and are willing to cooperate with follow-up.
Who cannot join
- Stage IV breast cancer, recurrent or metastatic breast cancer, or inflammatory breast cancer;
- A history of any malignant tumor, or having received anti-tumor treatment or radiotherapy for any malignant tumor in the past, excluding cured malignant tumors such as carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin;
- Concurrent participation in other clinical trials;
- Having received blood transfusion or treatment with colony-stimulating factors, etc. within 2 weeks before enrollment;
- Known history of allergy to the components of the drugs in this protocol;
- History of immunodeficiency, including positive HIV test, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation;
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- A history of any heart disease, including: angina pectoris; arrhythmia requiring drug treatment or with clinical significance; myocardial infarction; heart failure; any other heart disease judged by the researcher as unsuitable for participating in this trial;
- Pregnant or lactating female patients;
- Any other conditions that the researcher deems make the subject unsuitable for participating in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy in Early-stage HR-positive/HER2-negative Breast Cancer: a Multicenter, Prospective Clinical Study
This study aims to evaluate the efficacy and safety of adjuvant endocrine therapy combined with dalpiciclib at different doses and durations in patients with hormone receptor (HR)-positive, HER2-negative early-stage breast cancer.
It is a multicenter, prospective clinical study. All enrolled patients will receive either dalpiciclib 125 mg for 2 years or dalpiciclib 100 mg for 3 years, in combination with standard endocrine therapy.
The primary endpoint is 3-year invasive disease-free survival (iDFS).
- Conditions
- Early Breast Cancer, Adjuvant Therapy, Hormone Receptor Positive / HER2-negative Breast Cancer
- Being tested
- Dalpiciclib, Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)
- Keywords
- dalpiciclib, hormone receptor positive/HER2-negative breast cancer, early breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DalpiciclibDrug
Dalpiciclib 100 mg orally, daily on days 1-21 of a 28-day cycle, for 3 years.
Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)Drug
Standard adjuvant endocrine therapy (e.g., tamoxifen or aromatase inhibitor), as per physician's choice.
DalpiciclibDrug
Dalpiciclib 125 mg orally, daily on days 1-21 of a 28-day cycle, for 2 years.
| Study group | Role | What they receive |
|---|---|---|
| 2-Year Dalpiciclib 125 mg + Endocrine Therapy | Experimental | Patients will receive dalpiciclib 125 mg orally once daily on days 1-21 of a 28-day cycle for 2 years, in combination with standard endocrine therapy. Receives: Drug: Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane); Drug: Dalpiciclib |
| 3-Year Dalpiciclib 100 mg + Endocrine Therapy | Experimental | Patients will receive dalpiciclib 100 mg orally once daily on days 1-21 of a 28-day cycle for 3 years, in combination with standard endocrine therapy. Receives: Drug: Dalpiciclib; Drug: Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-years Invasive Disease-Free Survival (iDFS)
Measured: 36 months from randomization
Secondary outcomes (4)
Distant Disease-Free Survival (DDFS)
Measured: Up to 48 months
Overall Survival (OS)
Measured: up to 48 months
Incidence and Severity of Adverse Events
According to Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0)
Measured: From treatment initiation to 30 days after the last dose, up to approximately 36 months
Patient-Reported Outcomes (PROs)
EORTC QLQ-C30 (version 3.0) Quality of Life Questionnaire.
The scores of each domain in the scale need to be converted into a 0 - 100 scale through standardized calculation:
Functional domains: Higher scores indicate better functional status. Symptom domains: Higher scores indicate more severe symptoms. Global quality of life: Higher scores indicate a better quality of life.
Measured: Baseline to end of follow-up (up to 48 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionDec 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101159
- Sponsor's protocol ID
- OBU-BC-II-304
- Status last verified
- Aug 2025
- First submitted
- 25 Jul 2025
- Last updated
- 3 Aug 2025
- 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 3 Aug 2025. 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 in Early-stage HR-positive/HER2-negative Breast Cancer: a Multicenter, Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07101159
- Acronym / sponsor ID
- OBU-BC-II-304
- Conditions
- Early Breast Cancer, Adjuvant Therapy, Hormone Receptor Positive / HER2-negative Breast Cancer
- Keywords
- dalpiciclib, hormone receptor positive/HER2-negative breast cancer, early breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 3 Aug 2025 (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 aims to evaluate the efficacy and safety of adjuvant endocrine therapy combined with dalpiciclib at different doses and durations in patients with hormone receptor (HR)-positive, HER2-negative early-stage breast cancer.
It is a multicenter, prospective clinical study. All enrolled patients will receive either dalpiciclib 125 mg for 2 years or dalpiciclib 100 mg for 3 years, in combination with standard endocrine therapy.
The primary endpoint is 3-year invasive disease-free survival (iDFS).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2-Year Dalpiciclib 125 mg + Endocrine Therapy | Experimental | Drug: Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane), Drug: DalpiciclibPatients will receive dalpiciclib 125 mg orally once daily on days 1-21 of a 28-day cycle for 2 years, in combination with standard endocrine therapy. |
| 3-Year Dalpiciclib 100 mg + Endocrine Therapy | Experimental | Drug: Dalpiciclib, Drug: Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)Patients will receive dalpiciclib 100 mg orally once daily on days 1-21 of a 28-day cycle for 3 years, in combination with standard endocrine therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female breast cancer patients aged ≥ 18 years, who are postmenopausal or premenopausal/perimenopausal;
- Histologically confirmed HR-positive, HER2-negative early-stage breast cancer (immunohistochemical detection shows ER ≥ 10% and/or PR ≥ 10%, HER2 0-1+ or HER2 ++ but negative and non-amplified by FISH or CISH detection);
- Histologically confirmed invasive breast cancer with postoperative pathological stage II-III;
- Patients with or without prior neoadjuvant chemotherapy or adjuvant chemotherapy are eligible for enrollment;
- The maximum time from surgery to enrollment does not exceed 12 months;
Key exclusion criteria (9 listed)
- Stage IV breast cancer, recurrent or metastatic breast cancer, or inflammatory breast cancer;
- A history of any malignant tumor, or having received anti-tumor treatment or radiotherapy for any malignant tumor in the past, excluding cured malignant tumors such as carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin;
- Concurrent participation in other clinical trials;
- Having received blood transfusion or treatment with colony-stimulating factors, etc. within 2 weeks before enrollment;
- Known history of allergy to the components of the drugs in this protocol;
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 |
|---|---|---|
| DalpiciclibDalpiciclib 100 mg orally, daily on days 1-21 of a 28-day cycle, for 3 years. | Drug | 3-Year Dalpiciclib 100 mg + Endocrine Therapy |
| Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)Standard adjuvant endocrine therapy (e.g., tamoxifen or aromatase inhibitor), as per physician's choice. | Drug | 2-Year Dalpiciclib 125 mg + Endocrine Therapy, 3-Year Dalpiciclib 100 mg + Endocrine Therapy |
| DalpiciclibDalpiciclib 125 mg orally, daily on days 1-21 of a 28-day cycle, for 2 years. | Drug | 2-Year Dalpiciclib 125 mg + Endocrine Therapy |
Primary outcome
3-years Invasive Disease-Free Survival (iDFS)
Time frame: 36 months from randomization
4 secondary outcomes
Distant Disease-Free Survival (DDFS)
Time frame: Up to 48 months
Overall Survival (OS)
Time frame: up to 48 months
Incidence and Severity of Adverse Events
Time frame: From treatment initiation to 30 days after the last dose, up to approximately 36 months
Patient-Reported Outcomes (PROs)
Time frame: Baseline to end of follow-up (up to 48 months)
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 3 Aug 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dalpiciclib and Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) in people with Early Breast Cancer and Adjuvant Therapy, run by Fujian Cancer Hospital.
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 9 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 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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 (+86 13960709993, songchuangui@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-years Invasive Disease-Free Survival (iDFS) (time frame: 36 months from randomization). 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 3 Aug 2025.