Advanced Breast Cancer
Conditions
Brief summary
to assess the effect of dalpiciclib plus letrozole and capecitabine of first-line treatment with breast cancer
Detailed description
The purpose of the study is to assess the effect of dalpiciclib plus letrozole and capecitabine of first-line treatment with high-risk for HR- positive /HER-2 negative advanced breast cancer
Interventions
DRUGDalpiciclib+ letrozole +capecitabine
Continue medication to disease progression
Sponsors
Fujian Medical University Union Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age:18-75 years old, Postmenopausal or premenopausal/perimenopausal female; 2. HR-positive, HER2-negative breast cancer diagnosed by pathology, patients have evidence of focal recurrence or metastasis, are not suitable for curative surgical resection or radiotherapy, and have no clinical indications for chemotherapy. 1. ER positivity and/or PR positivity is defined as: the proportion of tumor cells with positive staining is ≥ 1% of all tumor cells (confirmed by the investigator of the trial center); 2. HER2-negative is defined as: 0/1+ by standard immunohistochemistry (IHC); HER2/CEP17 ratio less than 2.0 or HER2 gene copy number less than 4 by ISH (confirmed by the investigator of the trial center). 3. Patients must meet one of the following criteria: 1. ≥2 organ metastases (internal organs) 2. Metastasis to a single organ (visceral organ) and meets at least one of the following criteria: * At least 2 or more measurable lesions * High histological/cytonuclear grade 3 as defined by the modified Bloom-Richardson grading system (also known as the Nottingham scale) * Ki67\>30% 3. Simple bone metastases combined with ≥ 1 other recurrent metastatic site 4. No received any prior systemic anticancer therapy for focal recurrent or metastatic disease. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 6. The main organs function well, and the inspection indicators meet the following requirements: 1. HB≥90g/L; 2. ANC≥1.5×109/L; 3. PLT≥100×109/L; 4. ALT and AST≤3×ULN, but≤5×ULN if the transferanse elevation is due to liver metastases； 5. TBIL≤1.5×ULN； 6. Serum creatinine ≤1.5×ULN; 7. There are measurable lesions meeting RECIST 1.1 criteria. 8. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment and be willing to use a medically-approved high-efficiency contraceptive during the study period and within 3 months after the last dose of study drug. 9. All acute toxicities of previous antitumor therapy were relieved to grade 0-1 (according to NCI CTCAE version 5.0) or to the level specified by the inclusion/
Exclusion criteria
. Other toxicities, such as alopecia, were excluded due to that the researchers believe do not pose a safety risk to patients. 10. Participants were willing to join in this study, and written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 24 month | Objective response rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CBR | 24 month | Clinical Benefit Rate |
Outcome results
None listed