Real-World Study on CDK4/6 Inhibitors Combined With Endocrine Therapy and Subsequent Treatment in HR+/HER2- MBC.

Launched by HUNAN CANCER HOSPITAL · Sep 5, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how well certain treatments work for patients with HR-positive, HER2-negative metastatic breast cancer, which means the cancer has spread beyond the breast but is sensitive to hormones. Specifically, the study will focus on patients who are currently receiving or plan to receive a combination of two types of treatments: CDK4/6 inhibitors, which help block cancer growth, and endocrine therapy, which targets hormone receptors. The researchers will follow over 300 participants to see how effective these treatments are and what happens next if the cancer progresses, meaning it continues to grow despite treatment. Doctors will choose the next course of treatment based on what is best for each patient.

To be eligible for this trial, participants must be at least 18 years old and have been diagnosed with HR-positive metastatic breast cancer. They should not have received prior systemic treatments and must be willing to follow the study procedures. Participants can expect regular visits and tests, including blood tests to monitor certain cancer markers. This study is important because it aims to gather real-world information on how these treatments work and how doctors can best manage the disease after the first line of treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Inclusion criteria:
• * Age ≥ 18 years, postmenopausal or pre/perimenopausal females, or male patients. Female patients must meet one of the following criteria:
• • 1. Prior bilateral oophorectomy or age ≥ 60 years.
• • 2. Age \< 60 with natural postmenopausal status (defined as spontaneous cessation of regular menstruation for at least 12 consecutive months without any other pathological or physiological reasons), and estradiol (E2) and follicle-stimulating hormone (FSH) levels consistent with postmenopausal range.
• • 3. Pre/perimenopausal females may also be eligible but must be willing to receive LHRH agonist during the study.
• * Pathologically confirmed HR-positive male/female breast cancer patients with evidence of localized recurrence or metastasis, who are not suitable for curative surgery or radiation therapy:
• • ER-positive and/or PR-positive defined as the proportion of positively stained tumor cells ≥ 1% of all tumor cells (as confirmed by the investigators at the participating center).
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• • No prior systemic treatment or currently receiving CDK4/6 inhibitors as first-line treatment for advanced disease.
• • Reproductive-age females must have a negative serum pregnancy test within 28 days before enrollment and male/female patients must be willing to use a medically approved highly effective contraceptive measure during the study period and up to 1 year after the last dose of investigational drug.
• • Non-pregnant or non-lactating females.
• • Not concurrently participating in any other ongoing study.
• • Patient or legally authorized representative has provided informed consent and is willing and able to comply with the planned visits, study treatment plan, laboratory tests, and other trial procedures.
• Exclusion Criteria:
• • 1. Any evidence of severe or uncontrolled systemic illnesses, including uncontrolled hypertension, active bleeding disorders, active infections including hepatitis B, hepatitis C, and human immunodeficiency virus, or severely impaired bone marrow reserve or organ function, including liver and kidney impairment, which, in the investigator's opinion, would greatly alter the risk/benefit balance.
• • Patient has not yet recovered from any CTCAE grade ≥ 3 toxicity related to prior treatment at the start of CDK4/6 inhibitor therapy.
• • Known history of allergy to CDK4/6 inhibitors, excipients, or drugs with a similar chemical structure or class as CDK4/6 inhibitors.
• • Patients deemed unsuitable for enrollment by the investigator.