RC48 for Neoadjuvant Chemotherapy of HER2 Positive Breast Cancer

Launched by XIJING HOSPITAL · Nov 14, 2021

Keywords

ClinConnect Summary

This clinical trial, called RC48 for Neoadjuvant Chemotherapy of HER2 Positive Breast Cancer, is exploring a new treatment option for women with a specific type of breast cancer known as HER2-positive breast cancer. HER2-positive means that the cancer cells have higher levels of a protein called HER2, which can make the cancer grow faster. In this study, researchers want to see how effective a drug called RC48 is when given before surgery (this is called neoadjuvant therapy) and compare its results to another treatment known as T-DM1.

To participate in this trial, women must be between 18 and 80 years old, have early or locally advanced HER2-positive breast cancer with a tumor larger than 2 cm or with cancer spread to the lymph nodes. They should also have good heart function and be able to understand the study requirements. The trial is not yet recruiting participants, but once it starts, participants can expect to receive RC48 and undergo regular check-ups to monitor their health and the cancer's response to the treatment. It's important for potential participants to be aware that individuals with certain health conditions or a history of other cancers may not be eligible for this study.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Enrolled were ≥ 18 years of age and \< 80 years of age
• • 2. Female or male breast cancer
• • 3. Patients with early or locally advanced breast cancer who are HER2-positive, have a tumor larger than 2 cm and/or have lymph node metastasis: HER2-positive is defined as 3 + by immunohistochemistry, or 2 + by immunohistochemistry, with a positive FISH test.
• • 4. Left ventricular score ≥ 55%
• • 5. ECOGPS score 0 or 1
• • 6. Able to understand the test requirements, willing and able to comply with the test and follow-up procedures
• • 7. Adequate organ function
• Exclusion Criteria:
• • 1. cardiac, hepatic, renal, or psychiatric disease history
• • 2. History of other malignancy within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.