Breast CancerNCT06605690
An Exploratory Clinical Study of Dalpiciclib an&Amp;#39;d Letrozole Combined With Anlotinib Neoadjuvant Therapy in Stage II-III Postmenopausal HR+/HER2- Early Breast Cancer
A study testing Dalpiciclib and Letrozole Combined With Anlotinib in people with Breast Cancer, run by Liu Shu.
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 and Letrozole Combined With Anlotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2024to 31 Aug 2026
- Phase
- Interventional
- 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
- Postmenopausal female patients, the definition of menopause:
- previous bilateral oophorectomy, or age ≥60 years; or(2) 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 in postmenopausal levels.
- 2. All patients had estrogen receptor (ER) positive (> 10%), HER2 receptor-negative invasive breast cancer regardless of PR expression level. Follow 2018 Asc-cap HER2 negative Interpretation guidelines. Immunohistochemical (IHC) score 0,1 + or 2+ and in situ hybridization (ISH) confirmed by pathology laboratory The test was negative (HER-2/CEP17 ratio < 2.0); 3. Patients with initial treatment of stage II-III whose tumor stage meets AJCC 8th edition standard; 4. No known severe hypersensitivity to chemical compounds or endocrine therapy similar to dalpiciclib or dalpiciclib excipients; Known against anlotinib or anlotinib Compounds with similar excipients had no severe hypersensitivity 5. ECOG 0-1; 6. The patient must have the ability to swallow oral drugs; 7. The level of organ function must meet the following requirements:
- Bone marrow function ANC ≥ 1.5×109/L (no granulocyte stimulating factor was 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 2 puncture biopsies required by the protocol (puncture at the first diagnosis and puncture on the 15th day of medication) 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;
Show all 12Show fewer
- 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 Have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
- Pregnant and lactating women, women who are fertile and have a positive baseline pregnancy test or are unwilling to take effective treatment during the entire test period Female patients of reproductive age using contraceptives;
- Concomitant diseases (including but not limited to uncontrollable drugs) that, in the judgment of the investigator, seriously endanger the patient's safety or interfere with the patient's completion of the study Severe hypertension, severe diabetes, active infection, etc.);
- People with large risk of hemoptysis, such as patients with refractory hypertension; Blood system diseases such as idiopathic thrombocytopenic purpura, thrombocytopenia, etc.;Lung diseases such as active pulmonary tuberculosis and bronchiectasis; Patients with chronic liver disease such as cirrhosis, portal hypertension, etc., and other diseases that may present with massive hemoptysis disease;
- 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 and letrozole combined with Anlotinib in the neoadjuvant treatment of stage Ⅱ-Ⅲ Postmenopausal HR+/HER2- breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Dalpiciclib and Letrozole Combined With Anlotinib
- Keywords
- dalpiciclib;Anlotinib; Neoadjuvant Therapy HR+/HER2- 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.
Dalpiciclib and Letrozole Combined With AnlotinibDrug
Dalpiciclib: 150mg orally, once daily, d1-d21, every 28 days as a cycle (3 weeks / 1 week off) Letrozole: 2.5mg orally once daily (continuous) Anlotinib: 12mg orally, once daily, d1-d14, every 21 days as a cycle (use 2 weeks/stop 1 week). One of the last cycles of the new auxiliary The combination of anlotinib is not included in the treatment regimen to ensure that the time interval between anlotinib withdrawal and surgery is more than 2-3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Dalpiciclib and Letrozole Combined With Anlotinib Receives: Drug: Dalpiciclib and Letrozole Combined With Anlotinib |
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 posted20 Sep 2024
- Study start31 Oct 2024 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- alpiciclib and Letrozole Combined With Anlotinib
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liu Shu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liu Shu, The Affiliated Hospital Of Guizhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605690
- Sponsor's protocol ID
- Guizhou medical university
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of Dalpiciclib an&Amp;#39;d Letrozole Combined With Anlotinib Neoadjuvant Therapy in Stage II-III Postmenopausal HR+/HER2- Early Breast Cancer
- ClinicalTrials.gov ID
- NCT06605690
- Acronym / sponsor ID
- Guizhou medical university
- Conditions
- Breast Cancer
- Keywords
- dalpiciclib;Anlotinib; Neoadjuvant Therapy HR+/HER2- Early Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Liu ShuUniversity, hospital or other
- Study start
- 31 Oct 2024 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 20 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 and letrozole combined with Anlotinib in the neoadjuvant treatment of stage Ⅱ-Ⅲ Postmenopausal HR+/HER2- breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- alpiciclib and Letrozole Combined With Anlotinib
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Drug: Dalpiciclib and Letrozole Combined With AnlotinibDalpiciclib and Letrozole Combined With Anlotinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Postmenopausal female patients, the definition of menopause:
- previous bilateral oophorectomy, or age ≥60 years; or(2) 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 in postmenopausal levels.
- 2. All patients had estrogen receptor (ER) positive (> 10%), HER2 receptor-negative invasive breast cancer regardless of PR expression level. Follow 2018 Asc-cap HER2 negative Interpretation guidelines. Immunohistochemical (IHC) score 0,1 + or 2+ and in situ hybridization (ISH) confirmed by pathology laboratory The test was negative (HER-2/CEP17 ratio < 2.0); 3. Patients with initial treatment of stage II-III whose tumor stage meets AJCC 8th edition standard; 4. No known severe hypersensitivity to chemical compounds or endocrine therapy similar to dalpiciclib or dalpiciclib excipients; Known against anlotinib or anlotinib Compounds with similar excipients had no severe hypersensitivity 5. ECOG 0-1; 6. The patient must have the ability to swallow oral drugs; 7. The level of organ function must meet the following requirements:
- Bone marrow function ANC ≥ 1.5×109/L (no granulocyte stimulating factor was 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)
Key exclusion criteria (12 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 |
|---|---|---|
| Dalpiciclib and Letrozole Combined With AnlotinibDalpiciclib: 150mg orally, once daily, d1-d21, every 28 days as a cycle (3 weeks / 1 week off) Letrozole: 2.5mg orally once daily (continuous) Anlotinib: 12mg orally, once daily, d1-d14, every 21 days as a cycle (use 2 weeks/stop 1 week). One of the last cycles of the new auxiliary The combination of anlotinib is not included in the treatment regimen to ensure that the time interval between anlotinib withdrawal and surgery is more than 2-3 weeks. | 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 20 Sep 2024.
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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 study testing Dalpiciclib and Letrozole Combined With Anlotinib in people with Breast Cancer, run by Liu Shu.
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 6 inclusion and 12 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 20 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.
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 20 Sep 2024.