HR+/HER2- Advanced Breast Cancer
Conditions
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.
Detailed description
This is a prospective, single-arm, single-center, open, exploratory clinical study. Simon two-stage sample size calculation was used in this study, and the primary endpoint was objective response rate (ORR). P0=37.3% (POLAMA-4 experimental group data), P1=53.2%, unilateral α=0.05, 1-β=80% were set. PASS15 software was used to calculate 21 cases in the first stage, with a total sample size of 52 cases. If 8 patients in Phase I achieve an objective response, proceed to Phase II. Screening for histopathologically confirmed recurrent or metastatic ER-Low positive (1%-10%) and HER2-negative (IHC 0/1+ or IHC 2+ but ISH-) 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.
Interventions
DRUGDalpiciclib
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
Sponsors
Fujian Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
prospective, single-arm, single-center, open, exploratory clinical study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. 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). 3. Have not previously received any systemic anticancer therapy for recurrent or metastatic disease. 4. The physical status score of the Eastern Cancer Collaboration Group (ECOG) was 0-1. 5. Measurable lesions or bone metastases only (including osteolytic lesions or mixed osteolytic/osteoblastic lesions) that meet RECIST 1.1 criteria. 6. Adequate organ and bone marrow function. 7. 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. 8. Remission of all acute toxic reactions from previous antitumor therapy to grade 0-1 (according to NCICTCAE version 5.0) or to the level specified in the inclusion/
Exclusion criteria
. The exception is other toxicities, such as hair loss, that researchers believe do not pose a safety risk to patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | through study completion, an average of 2 year | To assess and compare objective response rate (ORR) using RECIST 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | through study completion, an average of 2 year | To assess and compare efficacy by progression-free survival (PFS) using Response Evaluation Criteria In Solid Tumors 1.1 \[RECIST 1.1\] |
Contacts
Primary ContactWu Fan, Ph.D
Backup ContactWu Fan, Ph.D
Outcome results
None listed