A Phase 1 Study of SRG-514 Administered Intraoperatively to the Site of Tumor Resection of Patients undergoing Breast-Conserving Cancer Surgery
Study of Investigational Medication Administered During Breast Cancer Surgery
Carla Fisher, MD
Primary Investigator
Brief description of study
Detailed description of study
This is a multicenter, first-in-human (FIH), open label, Phase 1 dose escalation and recommended Phase 2 dose (RP2D) extension trial with a primary objective to define the RP2D of SRG-514 when administered intraoperatively to patients undergoing breast-conserving cancer surgery. SRG-514 will be investigated utilizing a 3+3 convention dose escalation cohorts, with 3 to 6 patients enrolled at each dose level, and a minimum of 6 patients enrolled at the highest dose level, for a total of approximately 12-18 patients in the dose escalation portion of the study.
SRG-514 doses will be escalated based on safety and potential dose-limiting toxicities (DLTs) within the 14-day period following SRG-514 administration. Patients who do not complete the DLT period for reasons other than study drug related toxicity would be considered non-evaluable for DLT assessment and may be replaced.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Breast Cancer
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Age: 18 years - 100 years
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Gender: All
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.
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.
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.
This study investigates the use of an investigational medication given during surgery for patients undergoing breast-conserving cancer surgery. Breast-conserving surgery is a type of surgery where only the part of the breast containing the cancer is removed, not the whole breast. The purpose of this study is to find the best dose of the investigational medication to use during this surgery.
Participants will receive different doses of the investigational medication to see how safe it is and to find any side effects. The doses will be increased carefully to check for any problems. If a participant cannot complete the study period due to reasons not related to the study medication, they may be replaced. This helps ensure that the study collects enough data to understand the effects of the medication.
- Who can participate: Adults aged 18 and older who weigh more than 50 kg and have a confirmed diagnosis of breast carcinoma or ductal carcinoma in situ may join. They must be planning to have breast-conserving surgery and meet certain health criteria.
- Study details: Participants will receive the investigational medication during their surgery. The study will check for any side effects and determine the best dose for future studies.
