Experimental population:Advanced first-line HR+, HER2 metastatic breast cancer patients
Research endpoint:
Main research endpoint:
PFS evaluated by researchers (according to RECIST 1.1 standard)
Secondary study endpoint:
ORR、CBR、DCR、OS The incidence of adverse events (AE) and severe adverse events (SAE)
Exploratory study endpoint:
Tumor infiltrating lymphocytes (sTIL) Peripheral blood lymphocyte ratio Distribution of fecal microbiota Research overall design:This study adopts a prospective, single arm design, and plans to include 36 postmenopausal or premenopausal/perimenopausal patients with metastatic breast cancer who are HR positive and HER2 negative, and receive maintenance treatment with darcy plus toremifene. In this study, the screening period did not exceed 28 days. After completing the screening examination and evaluation, eligible subjects entered the study treatment period and received maintenance treatment with darcilib combined with toremifen, for a period of 4 weeks until disease progression, intolerable toxicity, withdrawal of informed consent, or termination of medication as determined by the investigator. Conduct research according to the plan regulations Treatment and visits. Perform tumor imaging evaluation every 2 cycles (8 weeks ± 7 days) during the first 13 treatment cycles (52 weeks) of the treatment period; Afterwards, tumor imaging evaluation will be conducted every 3 cycles (12 weeks ± 7 days). Subjects should visit the research center at the end of treatment/withdrawal from the study to complete corresponding safety checks and imaging evaluations; And visit the research center 28 days after the last treatment to complete the corresponding safety assessment.
Postmenopausal or premenopausal/perimenopausal female patients aged ≥ 18 years and ≤ 75 years old,
ECOG PS 0-1；
Female breast cancer patients diagnosed as HR positive and HER2 negative by pathology have evidence of local recurrence or metastasis, which is not suitable for surgical resection or radiotherapy for the purpose of cure.
Blood routine
The previous pathological diagnosis was HER2 positive breast cancer.
Researchers determine patients who are not suitable for endocrine therapy. This includes late stage patients who have symptoms, have spread to the internal organs, and are at risk of life-threatening complications in the short term (including patients with uncontrollable exudates (chest, pericardium, abdominal cavity) through drainage or other methods, pulmonary lymphangitis, and more than 50% liver involvement).
The patient has undergone major surgical procedures unrelated to breast cancer within 4 weeks before enrollment, or has not fully recovered from such surgical procedures.
Patients with extensive advanced/metastatic, symptomatic visceral diseases, or known uncontrolled or symptomatic brain metastases.
Single group
Dalpiciclib，Toremifen
Drug1. Dalpiciclib : 150mg orally, once a day, taken for 3 weeks, stopped for 1 week, with a cycle of 4 weeks. It is recommended to take medication at the same time every day, with warm water for delivery. It is recommended to do so on an empty stomach and fast for at least 1 hour before and after taking the medication. 2. Toremifen: 60mg orally, once a day If it is a premenopausal or perimenopausal patient, it is necessary to combine with OFS (OFS includes bilateral ovariectomy or GnRHa drugs).
PFS
The time from randomization to disease progression evaluated by researchers for patients
Click on the lead sponsor to view all of their trials.
