Albumin-bound Paclitaxel、Dalpiciclib and AI in ER-Low (1%-10%) HER2-ABC

NCT06711094 | Not Yet Recruiting

• 1 other identifier: Fujian Cancer Hospital
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, single-arm, single-center, open, exploratory clinical study.. Screening for histopathologically confirmed recurrent or metastatic ER-Low positive (1%-10%) and HER2-negative breast cancer patients who meet the inclusion criteria and have not previously received any systemic anticancer therapy for advanced disease, He was treated with albumin-bound paclitaxel in combination with Dalpiciclib and AI.

Conditions

HR+/HER2- Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  To assess and compare objective response rate (ORR) using RECIST 1.1

  through study completion, an average of 2 year

Secondary Outcomes (1)

• PFS

  through study completion, an average of 2 year

Study Arms (1)

experimental

EXPERIMENTAL

albumin-bound paclitaxel、Dalpiciclib and AI

Drug: Dalpiciclib

Interventions

Dalpiciclib DRUG

Dalpiciclib: 125mg orally, with a treatment cycle every 28 days, with continuous administration for the first 3 weeks (days 1 to 21) and rest (no medication) for the second 1 week (days 22 to 28). It is recommended to take Dalpiciclib at about the same time every day. Albumin-bound paclitaxel for injection: 125mg/m2, intravenous infusion for 30 minutes, D1, D8, every 28 days for a treatment cycle, at least ≥6 treatment courses. Endocrine therapy: Endocrine therapy drugs are selected by the investigator

experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal or premenopausal/perimenopausal women ≥18 years old and ≤75 years old, meeting one of the following criteria: a) prior bilateral oophorectomy, or ≥60 years old; Or b) 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; Or c) premenopausal or perimenopausal women may also be enrolled, but must be willing to receive LHRH agonist therapy during the study period.
• Female breast cancer patients diagnosed by pathology as ER-Low positive (1%-10%) and HER2-negative have evidence of focal recurrence or metastasis, and are not suitable for surgical resection or radiotherapy for the purpose of cure. a) Low ER expression was defined as: the proportion of tumor cells with positive staining accounted for ≥ 1% and ≤10% of all tumor cells (confirmed by investigators in the study center); b) HER2 negative is defined as a standard immunohistochemical (IHC) test of 0/1+; Or the IHC test is 2+ and the ISH test is negative (reviewed and confirmed by the investigator at the study center).
• Have not previously received any systemic anticancer therapy for recurrent or metastatic disease.
• The physical status score of the Eastern Cancer Collaboration Group (ECOG) was 0-1.
• Measurable lesions or bone metastases only (including osteolytic lesions or mixed osteolytic/osteoblastic lesions) that meet RECIST 1.1 criteria.
• Adequate organ and bone marrow function.
• Women of reproductive age must have a negative serum pregnancy test within 7 days prior to enrollment and be willing to use a medically approved highly effective contraceptive during the study period and within 3 months after the last study drug administration.

You may not qualify if:

• Previous pathological examination diagnosed HER2-positive breast cancer.
• Inflammatory breast cancer.
• Disease progression or recurrence during prior adjuvant therapy or within 12 months after completion of adjuvant therapy.
• Patients judged unsuitable for chemotherapy by the investigators. This includes symptomatic, advanced patients who have spread to the viscera and are at risk of developing life-threatening complications in the short term (including patients with uncontrolled exudation \[thoracic, pericardial, abdominal\], pulmonary lymphangitis, and more than 50% liver involvement).
• Patients with symptomatic active brain metastases or meningeal metastases were confirmed by cranial CT or MRI.
• Previous treatment with any CDK4/6 inhibitors.
• Major surgery, chemotherapy, radiation therapy, any investigational drug, or other anti-cancer treatment within 2 weeks prior to study entry.
• Any other malignant tumor diagnosed within 3 years prior to study entry, except for non-melanoma skin cancer, basal cell or squamous cell skin cancer, or cervical carcinoma in situ after radical treatment.
• Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥1000 IU/ml), hepatitis C (HCV antibody positive and HCV-RNA above the lower detection limit of analytical methods), or co-infection with hepatitis B and hepatitis C.
• Within 6 months prior to entering the study, the following situations occurred: Myocardial infarction, severe/unstable angina pectoris, NYHA grade 2 or higher cardiac insufficiency, persistent arrhythmias ≥ grade 2 (according to NCI CTCAE 5.0), atrial fibrillation of any grade, coronary/peripheral artery bypass surgery, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism).
• Severe infection within 4 weeks prior to the first dose (e.g. intravenous antibiotic, antifungal, or antiviral medication required according to clinical practice), or unexplained fever \>38.5°C during screening/prior to the first dose.
• Inability to swallow, intestinal obstruction, or other factors affecting the administration and absorption of medications.
• Known allergy to albumin-bound paclitaxel, letrozole, anastrozole, Metrotan, LHRH agonists (goserrelin, leprerelin), Darcilil, or any excipients.
• Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• Known history of psychotropic substance abuse or drug use.

Sponsors & Collaborators

• Fujian Medical University: lead

MeSH Terms

Interventions

dalpiciclib

Central Study Contacts

Wu Fan, Ph.D

CONTACT

13859082118; alienglass@fjmu.edu.cn

Wu Fan, Ph.D

CONTACT

83660063; alienglass@fjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: prospective, single-arm, single-center, open, exploratory clinical study

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 2, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share