Breast CancerPhase 4NCT06613373
An Exploratory Clinical Study of CDK4/6i Dalpiciclib Combined With AI Neoadjuvant Therapy for Stage II-III HR+/HER2- Breast Cancer
A Phase 4 study testing Dalpiciclib in people with Breast Cancer, run by Jiangsu Famous Medical Technology Co., Ltd..
Trial summary
This is a single-arm, open-label, exploratory clinical study 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?
- Dalpiciclib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2024to 30 Oct 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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. For premenopausal or postmenopausal women, the definition of menopause:
- previous bilateral oophorectomy, or age ≥60 years; or
- Age <60, natural postmenopausal status (defined as spontaneous cessation of regular menstruation for at least 12 consecutive months without other pathological or physiological causes), E2 and FSH at postmenopausal levels; 2. All patients had estrogen receptor (ER) positive (> 10%), HER2 receptor-negative invasive breast cancer regardless of PR expression level. Follow the 2018 ASC-CAP HER2 Negative Interpretation Guidelines. Immunohistochemical (IHC) scores of 0+ or 2+ and in situ hybridization (ISH) test negative were confirmed by pathology laboratory (HER-2/CEP17 ratio < 2.0); 3. Patients with initial treatment of stage II-III whose tumor stage meets AJCC 8th edition standard; 4. There is no known severe hypersensitivity to compounds or endocrine therapy similar to Darcilil or darcilil excipients.
- 5. ECOG 0-1; 6. The patient must be able to swallow oral medications. 7. The functional level of the organ must meet the following requirements:
- Bone marrow function ANC ≥ 1.5×109/L (no growth factor used within 14 days); PLT ≥ 100×109/L (no corrective therapy used within 7 days); Hb ≥ 100 g/L (no corrective therapy used within 7 days);
- Liver and kidney function TBIL≤1.5×ULN; ALT and AST≤3×ULN (ALT and AST≤5×ULN in patients with liver metastasis); BUN and Cr≤1.5×ULN and creatinine clearance ≥50 mL/min (Cockcroft-Gault formula);
- 12-lead electrocardiogram QT interval ≤480 ms; 8. Able to accept all needle biopsies required by the protocol; 9. Voluntarily participate in this study, sign informed consent, have good compliance and be willing to cooperate with follow-up.
Who cannot join
- Previously received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
- At the same time receive any anti-tumor treatment other than that prescribed in other protocols;
- Bilateral breast cancer, inflammatory breast cancer or ocessive breast cancer;
- Stage IV breast cancer;
- Other malignant tumors have appeared in the past 5 years;
- Severe heart, liver, kidney and other vital organ dysfunction;
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- Inability to swallow, chronic diarrhea, and intestinal obstruction, with multiple factors affecting drug use and absorption;
- Known allergic history of the drug components of this protocol; Have a history of immunodeficiency, including HIV positive, HCV, active viral hepatitis B or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;
- Pregnant and lactating women, fertile women who tested positive for baseline pregnancy tests, or women of childbearing age who were unwilling to take effective contraceptive measures during the entire test period;
- Concomitant diseases (including but not limited to severe high blood pressure, severe diabetes, active infection, etc.) that, in the judgment of the investigator, seriously endanger the patient's safety or affect the patient's ability to complete the study;
- Have a clear history of neurological or mental disorders, including epilepsy or dementia. The investigator did not consider the patient suitable for participation in any other condition of the study.
About this study
This is a single-arm, open-label, exploratory clinical study
Read the detailed description
This is a single-arm, open-label, exploratory clinical study initiated by the investigator to evaluate the objective response rate (ORR), efficacy, and safety of Dalpiciclib combined with AI in the neoadjuvant treatment of stage Ⅱ-Ⅲ HR+/HER2- breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Dalpiciclib
- 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: 150 mg (p.o.) was given once daily for 3 weeks, followed by 1 week off in each 4-week cycle.
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Dalpiciclib combined with AI,28 days as one cycle.
Dalpiciclib: 150 mg (p.o.) was given once daily for 3 weeks, followed by 1 week off in each 4-week cycle.
Letrozole: 2.5mg, p.o., once a day, continuous administration. Receives: Drug: Dalpiciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start15 Oct 2024 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2026 (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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Famous Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613373
- Sponsor's protocol ID
- OBU-BC-II-093
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 25 Sep 2024
- 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 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of CDK4/6i Dalpiciclib Combined With AI Neoadjuvant Therapy for Stage II-III HR+/HER2- Breast Cancer
- ClinicalTrials.gov ID
- NCT06613373
- Acronym / sponsor ID
- OBU-BC-II-093
- Conditions
- Breast Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jiangsu Famous Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 25 Sep 2024 (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 is a single-arm, open-label, exploratory clinical study
Detailed description
This is a single-arm, open-label, exploratory clinical study initiated by the investigator to evaluate the objective response rate (ORR), efficacy, and safety of Dalpiciclib combined with AI in the neoadjuvant treatment of stage Ⅱ-Ⅲ HR+/HER2- breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Drug: DalpiciclibDalpiciclib combined with AI,28 days as one cycle. Dalpiciclib: 150 mg (p.o.) was given once daily for 3 weeks, followed by 1 week off in each 4-week cycle. Letrozole: 2.5mg, p.o., once a day, continuous administration. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- -
- previous bilateral oophorectomy, or age ≥60 years; or
- Age <60, natural postmenopausal status (defined as spontaneous cessation of regular menstruation for at least 12 consecutive months without other pathological or physiological causes), E2 and FSH at postmenopausal levels; 2. All patients had estrogen receptor (ER) positive (> 10%), HER2 receptor-negative invasive breast cancer regardless of PR expression level. Follow the 2018 ASC-CAP HER2 Negative Interpretation Guidelines. Immunohistochemical (IHC) scores of 0+ or 2+ and in situ hybridization (ISH) test negative were confirmed by pathology laboratory (HER-2/CEP17 ratio < 2.0); 3. Patients with initial treatment of stage II-III whose tumor stage meets AJCC 8th edition standard; 4. There is no known severe hypersensitivity to compounds or endocrine therapy similar to Darcilil or darcilil excipients.
- 5. ECOG 0-1; 6. The patient must be able to swallow oral medications. 7. The functional level of the organ must meet the following requirements:
- Bone marrow function ANC ≥ 1.5×109/L (no growth factor used within 14 days); PLT ≥ 100×109/L (no corrective therapy used within 7 days); Hb ≥ 100 g/L (no corrective therapy used within 7 days);
Key exclusion criteria (11 listed)
- Previously received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
- At the same time receive any anti-tumor treatment other than that prescribed in other protocols;
- Bilateral breast cancer, inflammatory breast cancer or ocessive breast cancer;
- Stage IV breast cancer;
- Other malignant tumors have appeared in the past 5 years;
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: 150 mg (p.o.) was given once daily for 3 weeks, followed by 1 week off in each 4-week cycle. | Drug | experimental |
Primary outcome
ORR
Time frame: 24 month
Objective response rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dalpiciclib in people with Breast Cancer, run by Jiangsu Famous Medical Technology Co., Ltd..
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 11 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: status not confirmed, as of the sponsor's last update on 25 Sep 2024. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 24 month). 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 25 Sep 2024.