Study on Combined Immunotherapies for Metastatic ER+ Breast Cancer

Inclusion Criteria

• Women aged 18 or older, both premenopausal and postmenopausal.
• Have metastatic breast cancer with up to 5 measurable sites.
• Eligible for treatment with CDK4/6 inhibitors and aromatase inhibitors.
• Premenopausal women must meet specific criteria, such as having had a menstrual period in the last 12 months or specific hormone levels if on certain medications.
• Women who have had their ovaries removed are eligible.
• Postmenopausal women must meet specific criteria, such as being without a menstrual period for at least 2 years or having hormone levels confirming postmenopausal status.
• Good overall health with an ECOG performance status of 0 or 1.
• Confirmed diagnosis of HR+HER2- metastatic breast cancer with ER expression over 10%.
• Ability to understand and sign a consent form.
• Meet specific blood count and organ function criteria, including adequate white blood cells, neutrophils, platelets, hemoglobin, kidney, and liver function.

Exclusion Criteria

• Have active connective tissue disorders like lupus or scleroderma needing treatment.
• Currently using systemic chemotherapy, hormone therapy, or HER2-targeted therapy.
• Have any cancer lesion larger than 5 cm.
• Cannot provide proof of metastatic breast cancer.
• Have an immune deficiency or are on high-dose steroids or other immunosuppressive treatments.
• Have another progressing cancer or one treated in the last 3 years, except for certain skin cancers or cervical cancer in situ.
• Have an active autoimmune disease needing treatment in the last 2 years, except for replacement therapies.
• Have an active infection needing treatment or a history of HIV.
• Have psychiatric or substance abuse issues that would affect participation.
• Have uncontrolled brain metastases.