SRG-514 Administered Intraoperatively to Patients Undergoing Breast-conserving Cancer Surgery

Launched by SURGE THERAPEUTICS · Mar 7, 2024

Keywords

ClinConnect Summary

This clinical trial, called SRG-514, is looking at a new treatment for patients with breast cancer who are undergoing surgery to remove their tumors while preserving as much healthy breast tissue as possible. The main goal of the study is to find the best dose of the drug SRG-514 that can be given during the surgery. This trial is in the early stages, known as Phase 1, where researchers are carefully observing how the drug works in people for the first time.

To participate in this trial, you need to be at least 18 years old and weigh more than 50 kilograms. You should have a confirmed diagnosis of breast cancer and plan to have surgery aimed at treating your cancer. However, if you have certain medical conditions or need specific types of surgery, you may not be eligible. If you join the trial, the researchers will monitor your health closely and provide you with information about what to expect during the process. It's essential to know that this trial is currently recruiting participants, and everyone involved is hopeful that the findings will contribute to better treatment options for breast cancer in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged 18 years or older
• • Body weight \>50kg
• • Have a history of histologically confirmed diagnosis of breast carcinoma or ductal carcinoma in situ, except inflammatory breast cancer.
• • Plan to undergo breast-conserving surgical treatment of breast cancer with curative intent. Adjuvant or neoadjuvant chemotherapy is allowed.
• • Have Eastern Cooperative Oncology Group (ECOG) Performance Status \<2
• • Have adequate organ and bone marrow function at screening
• Exclusion Criteria:
• • Any known contraindication to ketorolac or other non-steroidal anti-inflammatory drugs (NSAIDs)
• • Patients anticipated to require the use of a drain after breast-conserving surgery (BCS)
• • Patients undergoing immediate reconstruction surgery, intraoperative radiation therapy (IORT) or brachytherapy requiring the placement of balloons or catheters during the lumpectomy procedure.