New drug given during breast cancer surgery shows early promise
NCT ID NCT06300411
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tested a new drug called SRG-514 in 25 people undergoing breast-conserving surgery for breast cancer. The drug was given directly into the area where the tumor was removed. The main goal was to find a safe dose and check for side effects. This is a first step to see if the approach might help control breast cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SRG-514 (a drug containing ketorolac)
- What this could lead to
- If it works, this could lead to a new treatment given during breast cancer surgery to help control the disease.
- What could go wrong
- This is a very early, small phase 1 trial focused on safety, not effectiveness. It may not show benefit or could have side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
25 people
The number who actually took part.
- Started
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Jul 2024
- Finished
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Apr 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Audie Murphy VA
San Antonio, Texas, 78229, United States
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Duke Cancer Center
Durham, North Carolina, 27710, United States
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Indiana University
Indianapolis, Indiana, 46202, United States
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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Mayo
Rochester, Minnesota, 55905, United States
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Memorial Health
Savannah, Georgia, 31404, United States
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NYU Langone Health
New York, New York, 10016, United States
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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