a study of xzp-3287 in combination with letrozole/anastrozole in patients with advanced breast cancer

Conditions: Advanced Breast Cancer

Summary: this is a phase iii clinical trial designed to evaluate the efficacy and safety of xzp-3287 in combination with letrozole/anastrozole versus placebo in combination with letrozole/anastrozole in patients with hr-positive and her2-negative recurrent/metastatic breast cancer who have not received systemic anticancer therapy.


Eligibility criteria:
inclusion criteria: 1. female patients aged ≥18 years and ≤75 years old; 2. patient is in the menopausal state； 3. histologically or cytologically confirmed locally advanced, recurrent or metastatic breast cancer, which was pathologically confirmed to be hr-positive and her2-negative; 4. evidence of locally advanced, recurrent, or metastatic disease that is not amenable to curative surgical resection or radiation therapy and is not clinically amenable to chemotherapy; 5. no prior systemic anticancer therapy for locally advanced, recurrent, or metastatic disease; 6. at least one measurable lesion (based on recist v1.1) or only bone metastases; 7. patient has an eastern cooperative oncology group (ecog) performance status 0 or 1; 8. adequate organ and marrow function; 9. patient of childbearing age must undergo a serum pregnancy test within 7 days before randomization, and the result is negative; patient is willing to use a medically approved high-efficiency contraceptive method during the study period and within 6 months after the last study drug treatment; 10. patient with acute toxic reactions caused by previous anti-tumor treatments or surgical operations were alleviated to grade 0 to 1 (nci-ctcae v5.0), or to the level specified by the enrollment criteria; 11. patient has signed informed consent before any trial related activities. exclusion criteria: 1. patients with disease recurrence or metastasis at or within 12 months after previous neoadjuvant or adjuvant therapy with endocrine drugs; 2. patient with visceral crisis or brain metastases, except for patient with stable brain metastases; 3. patient had clinically significant pleural effusions, ascites effusions, or pericardial effusions in the 4 weeks before enrollment; 4. patient who received prior treatment with mtor inhibitors or cdk4/6 inhibitors ; 5. participation in a prior treatment of major surgery, chemotherapy, radiotherapy, and any anti-tumor treatment within 14 days before enrollment； 6. patient who participated in other clinical trials within 14 days before enrollment or within 5 half-lives of the trial drug, whichever is longer; 7. patient used cyp3a4 potent inhibitors or potent inducers within 14 days before enrollment or within 5 half-lives of the drug, whichever is longer; 8. initiation of bisphosphonates or rankl inhibitors within 7 days before enrollment, and subjects who have initiated treatment \> 7 days before enrollment should not change the method of use; 9. any other malignant tumor has been diagnosed within 5 years before randomization; 10. patient is in the active stage of hbv, hcv or co-infected with hbv, hcv, or patient with positive hiv antibody; 11. patient with severe infection within 4 weeks before enrollment, or unexplained fever\> 38.3℃ during screening/before enrollment; 12. patient with heart function impaired or clinically significant heart disease within 6 months before enrollment; 13. cerebrovascular accident occurred within 6 months before enrollment, including history of transient ischemic attack or stroke; pulmonary embolism; 14. inability to swallow, intestinal obstruction or other factors that affect the taking and absorption of the drug; 15. patient with a known hypersensitivity to any of the excipients in this study; 16. a prior history of autologous or allogeneic hematopoietic stem cell transplantation; 17. a prior history of psychotropic drug abuse or drug use; 18. nursing mothers; 19. the researchers considered that there were some cases that were not suitable for inclusion.

Keywords: xzp-3287 hr positive her2 negative recurrent/metastatic breast cancer