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Not yet recruitingPhase 3

Phase 3 Trial of SRG-514 Administered Intraoperatively to Patients Undergoing Breast-Conserving Surgery

A Randomized, Phase 3 Trial of SRG-514 Administered Intraoperatively to the Site of Tumor Resection in Patients Undergoing Breast-Conserving Surgery for Triple Negative Breast Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This Phase 3 study tests SRG-514, a drug containing ketorolac, placed in the space where a breast tumor is removed during surgery. It compares the drug plus usual care with usual care alone. It is for adults with stage II–III triple-negative breast cancer who plan to have breast-saving surgery and have not had cancer treatment before surgery.

This is a Phase 3 trial to compare SRG-514 (active pharmaceutical ingredient \[API\]: ketorolac) administered intraoperatively to the tumor resection cavity with standard-of-care (SOC) versus SOC alone in participants with clinical stage II-III triple negative breast cancer (TNBC) undergoing breast-conserving surgery (BCS) who are neoadjuvant therapy naïve.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 years old.
  • Tissue tests confirmed stage II–III triple-negative breast cancer, a cancer that lacks three common cell markers. Inflammatory breast cancer is not included.
  • Cancer in both breasts or in more than one spot is allowed. Each spot must have a confirmed diagnosis.
  • You can care for yourself and are up and about for at least half of your waking hours, even if you cannot work.
  • You plan to have breast-saving surgery aimed at curing the cancer within 28 days of screening.

Who can't join

  • You are expected to need a tube to drain fluid after breast-saving surgery.
  • You have already had cancer treatment before surgery.
  • You plan to have breast reconstruction during the same surgery using tissue and its blood supply moved from a distant body site. Reshaping nearby breast tissue to close the wound is allowed.
  • You plan to have radiation during surgery, or internal radiation that requires balloons or tubes placed during tumor removal.
  • You had another invasive cancer within 5 years before signing the consent form. Exceptions include adequately treated basal cell or squamous cell skin cancer, or cervical cancer that has not spread beyond its starting layer.
  • You have stage IV cancer, meaning it has spread to distant parts of the body.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Eligible participants will be adults (≥18 years old) who have a history of histologically confirmed diagnosis of TNBC (clinical stage II-III), except inflammatory breast cancer. Bilateral and/or multifocal primary tumors are allowed. For multifocal/multicentric disease, diagnosis needs to be confirmed for each focus. Participants have confirmed TNBC (as defined by the 8th edition of American Joint Committee on Cancer \[AJCC\] cancer staging manual and National Comprehensive Cancer Network \[NCCN\] guidelines), Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of ≤2, and plan to undergo breast-conserving surgical treatment of breast cancer with curative intent within 28 days of Screening. Exclusion Criteria: * Participants will not be eligible if they anticipate requiring the use of a drain after BCS, and/or have received neoadjuvant therapy, and/or are undergoing immediate reconstruction surgery with flaps involving transposition of a vascularized tissue flap from a remote donor site (oncoplastic closures are allowed), intraoperative radiation therapy (IORT) or brachytherapy requiring the placement of balloons or catheters during the lumpectomy procedure, and/or have a history of invasive malignancy (other than the disease under trial, ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer), and/or have stage IV disease.

Study sites (3)

MN

NC

NY