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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат BCS + SRG-514
  BCS + SRG-514
• Процедура BCS
  BCS

Первичные конечные точки

• EFS by BICR assessment [Срок оценки: EFS is defined as the time from randomization to the first occurrence of an event up to 5 years post BCS.]

Вторичные конечные точки (1)

• Incidence and severity of TEAEs [Срок оценки: Events will be followed for up to 5 years post BCS.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 3 центра

• Mayo — Rochester
• NYU Langone Health — New York
• Duke Cancer Center — Durham

Идентификаторы

NCT: NCT07723469 · SRG-514-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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