Reverse HER2-negative Immune Resistant Breast Cancer

Launched by FUDAN UNIVERSITY · Dec 9, 2024

Keywords

ClinConnect Summary

This clinical trial, called the "Reverse Luminal Immune Resistant Breast Cancer" study, is exploring a new treatment approach for women with luminal breast cancer who have not responded well to previous immune therapies. Specifically, the trial is testing a combination of retinoic acid and an immune checkpoint inhibitor, which is a type of treatment that helps the body’s immune system fight cancer. The study is currently recruiting participants who are between the ages of 65 and 74, and the goal is to see if this new combination therapy is safe and effective for women whose cancer has worsened after other treatments.

To be eligible for this trial, participants should have a specific type of breast cancer that has shown evidence of progression after earlier treatments. They also need to have a good performance status, meaning they can carry out daily activities without too much difficulty. Women who are able to have children must agree to use birth control during the study. Participants can expect close monitoring throughout the trial, including regular health check-ups and tests to assess how well the treatment is working. It’s important to note that certain health conditions, recent treatments, and pregnancy can exclude potential participants from joining the study.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • ECOG Performance Status of 0, 1, or 2
• • Metastatic or locally advanced, histologically confirmed luminal breast cancer (defined as: ER positive when immunohistochemistry shows \>1% positive tumor cells, PR positive when \>1% tumor cells are positive, and HER2 negative when scored as 0-1+ or when HER2 2+ shows no amplification by FISH or CISH) or triple negative breast cancer (defined as: ER negative when immunohistochemistry shows \<1% positive tumor cells, PR negative when \<1% tumor cells are positive, and HER2 negative when scored as 0-1+ or when HER2 2+ shows no amplification by FISH or CISH).
• • Radiologic/objective evidence of recurrence or disease progression after immunotherapy (combined with targeted therapy or chemo ) for metastatic breast cancer (MBC)
• • Adequate hematologic and end-organ function, laboratory test results, obtained within 14 days prior to initiation of study treatment.
• • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as outlined for each specific treatment arm
• • Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
• • have the cognitive ability to understand the protocol and be willing to participate and to be followed up.
• Exclusion Criteria:
• • Symptomatic, untreated, or actively progressing CNS metastases
• • Active or history of autoimmune disease or immune deficiency
• • Significant cardiovascular disease
• • History of malignancy other than breast cancer within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death
• • Treatment with chemotherapy, radiotherapy, immunotherapy or surgery (outpatient clinic surgery excluded) within 3 weeks prior to initiation of study treatment.
• • Pregnancy or breastfeeding, or intention of becoming pregnant during the study
• • History of allergies to the drug components of this trial
• • History of eosinophilosis or mastocytosis
• • Patients who have been using oral steroid hormones for a long time will need to stop for 4 weeks if they have used them occasionally in the past