A Study to Evluate Efficacy and Safety of HRS-8080 Combined With Dalpiciclib in Patients With Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy.

Shandong Suncadia Medicine

Status and phase: Begins enrollment in 9 months; Phase 3

Conditions: Locally Advanced or Metastatic Breast Cancer

Treatments: Drug: HRS-8080 Tablet ; Dalpiciclib Isethionate; Drug: Fulvestrant injection ;Dalpiciclib Isethionate

Study type: Interventional

Funder types: Industry

Identifiers

NCT07354022

HRS-8080-301

Details and patient eligibility

About

The study is being conducted to evaluate the efficacy and safety of HRS-8080 combined with dalpiciclib versus fulvestrant combined with dalpiciclib in patients with locally advanced/metastatic breast cancer who had developed drug resistance to prior adjuvant endocrine therapy.

Enrollment: 912 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women aged 18 - 75 years old;
2. Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1;
3. Patients with histologically confirmed locally advanced or metastatic breast cancer;
4. Patients with prior adjuvant endocrine resistance following curative-intent surgery;
5. Menstrual status: postmenopausal, perimenopausal, or premenopausal;
6. Presence of evaluable lesions;
7. Organ function must meet required criteria.

Exclusion criteria

1. Patients with rapidly progressing disease, as judged by the investigator to be unsuitable for endocrine therapy;
2. Patients who have previously received fulvestrant or other novel SERMs (excluding tamoxifen and toremifene);
3. Patients with uncontrolled brain metastases, carcinomatous meningitis, or spinal cord compression;
4. Patients with a history of clinically significant cardiovascular disease;
5. Participants who have not recovered from adverse effects caused by prior therapies;
6. Participants with a history of another malignancy within the past 5 years or currently having another malignancy;
7. Known hypersensitivity to HRS-8080, fulvestrant, dalpiciclib, or any of their components, etc.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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912 participants in 2 patient groups

HRS-8080 combined with Dalpiciclib

Experimental group

Treatment:

Drug: HRS-8080 Tablet ; Dalpiciclib Isethionate

Fulvestrant combined with Dalpiciclib

Active Comparator group

Treatment:

Drug: Fulvestrant injection ;Dalpiciclib Isethionate