TNBC - Triple-Negative Breast Cancer
Conditions
Keywords
Intraoperative, Ketorolac, SRG-514, Breast Cancer, TNBC, Lumpectomy, Breast Conserving Surgery, Immunotherapy
Brief summary
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.
Detailed description
This is a Phase 3, multicenter, randomized, blinded 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. Participants will be randomized 1:1 to receive SOC plus SRG-514 administered intraoperatively (treatment group) or SOC alone (control group). All participants will receive pre-operative and post-operative SOC.
Interventions
DRUGBCS + SRG-514
BCS + SRG-514
PROCEDUREBCS
BCS
Sponsors
SURGE Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Participants will receive 514 + BCS or BCS alone.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EFS by BICR assessment | EFS is defined as the time from randomization to the first occurrence of an event up to 5 years post BCS. | To compare the efficacy of SOC plus SRG-514 administered intraoperatively to the tumor resection site versus SOC alone in participants undergoing BCS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of TEAEs | Events will be followed for up to 5 years post BCS. | To determine the safety and tolerability of SRG-514 administered intraoperatively to the tumor resection site in participants undergoing BCS |
Countries
United States
Contacts
CONTACTKayti Aviano
Outcome results
None listed