HR+/HER2- advanced breast cancer
Conditions
Interventions
Cummeciclib arm:Cummeciclib in combination with endocrine therapy
Sponsors
The affiliated people's hospital of Ningbo University
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Females aged 18 and above; 2. ECOG Performance Status score of 0 to 1; 3. Histologically or cytologically confirmed HR+/HER2- metastatic breast cancer; 4. HER2 negativity must be confirmed in both the primary tumor and metastatic sites (where biopsy results are available); 5. Radiographically evaluable metastatic disease; 6. Prior endocrine therapy for advanced disease limited to <=2 lines; 7. Prior chemotherapy for advanced disease limited to <=2 lines, including ADC-containing regimens; 8. All toxicities related to previous antitumor treatments must have recovered to <= grade 1 (CTCAE v5.0); 9. Asymptomatic central nervous system metastases are allowed for enrollment; 10. Complete blood count tests must be basically normal within one week before enrollment; 11. Liver and kidney function tests must be basically normal within one week before enrollment; 12. Expected survival of at least 12 weeks; 13. Must be able to participate in and comply with treatment and follow-up; 14. Sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1.HER2-positive status (IHC 3+ or FISH-positive); 2.History of another malignancy within 5 years prior to screening (including primary brain tumors or leptomeningeal disease), with the exception of cured basal cell skin cancer or cervical carcinoma in situ; 3.Receipt of any prior anticancer therapy within 2 weeks before the start of study treatment, including chemotherapy, definitive radiotherapy, biologic therapy, immunotherapy, or antitumor traditional Chinese medicine; 4.Major surgical procedure (excluding core needle biopsies) or clinically significant trauma within 4 weeks prior to the first dose of study drug, or anticipated need for elective surgery during the study; 5.Presence of symptomatic central nervous system (CNS) metastases; 6.Pregnant or lactating women; 7. Known or suspected allergy to any investigational drug or excipient; 8. Any other non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that may hinder the implementation of the treatment protocol or follow-up; 9. Any other condition that the investigator considers inappropriate for participation in this trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;Objective response rate, ORR;Disease control rate, DCR; | — |
Countries
China
Contacts
Public ContactZhang Yu
The affiliated people's hospital of Ningbo University
Outcome results
None listed