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

This is a single-arm, open-label, exploratory clinical study

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Dalpiciclib and Letrozole Combined With Anlotinib

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Postmenopausal female patients, the definition of menopause:

(1) 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:

1. 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);
2. 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)
3. 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.

Exclusion Criteria:

1. Previously received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
2. At the same time receive any anti-tumor treatment other than that prescribed in other protocols;
3. Bilateral breast cancer, inflammatory breast cancer or ocessive breast cancer;
4. Stage IV breast cancer;
5. Other malignant tumors have appeared in the past 5 years;
6. Severe heart, liver, kidney and other vital organ dysfunction;
7. Inability to swallow, chronic diarrhea, and intestinal obstruction, with multiple factors affecting drug use and absorption;
8. 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;
9. 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;
10. 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.);
11. 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;
12. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: experimental; Dalpiciclib and Letrozole Combined With Anlotinib

Drug: Dalpiciclib and Letrozole Combined With Anlotinib; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Objective response rate	24 month

Collaborators and Investigators

• Sponsor: Liu Shu

Study record dates

Study Major Dates

• Study Start (Estimated): October 31, 2024
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 20, 2024

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: dalpiciclib;Anlotinib; Neoadjuvant Therapy HR+/HER2- Early Breast Cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Letrozole
• Other Study ID Numbers: Guizhou medical university

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No