Идёт набор NCT06966700

A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)

Фаза III С лечением Breast Neoplasms Triple Negative Breast Neoplasms HR Low-Positive/HER2-Negative Breast Neoplasms

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Sacituzumab tirumotecan, Pembrolizumab, Rescue Medication, Carboplatin.
Кому может быть актуально: Состояния в реестре: Breast Neoplasms, Triple Negative Breast Neoplasms, HR Low-Positive/HER2-Negative Breast Neoplasms. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Аргентина, Австралия, Бельгия, Бразилия +34
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer

Обзор

Researchers are looking for new ways to treat types of breast cancer that are both: * High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment * Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone. Sacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread. The main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy: * Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy * Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy

Вмешательства

Биопрепарат Sacituzumab tirumotecan
IV infusion
Биопрепарат Pembrolizumab
IV infusion
Препарат Rescue Medication
Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medications are histamine -1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, or steroid mouthwash (dexamethasone or equivalent).
Препарат Carboplatin
IV infusion
Препарат Paclitaxel
IV infusion
Препарат Doxorubicin
IV infusion
Препарат Epirubicin
IV infusion
Препарат Cyclophosphamide
IV infusion
Препарат Capecitabine
Oral tablet
Препарат Olaparib
Oral tablet

Первичные конечные точки

Percentage of Participants with Pathological Complete Response (pCR) at the Time of Definitive Surgery [Срок оценки: Up to approximately 30 weeks]
Event-Free Survival (EFS) [Срок оценки: Up to approximately 92 months]

Вторичные конечные точки (12)

Overall Survival (OS) [Срок оценки: Up to approximately 115 months]
Percentage of Participants with pCR with No Ductal Carcinoma in Situ (pCR-no DCIS) at the Time of Definitive Surgery [Срок оценки: Up to approximately 30 weeks]
Percentage of Participants with pCR at the Time of Definitive Surgery (High-risk, early-stage, TNBC subset) [Срок оценки: Up to approximately 30 weeks]
Event-Free Survival (EFS) (High-risk, early-stage, TNBC subset) [Срок оценки: Up to approximately 92 months]
Overall Survival (OS) (High-risk, early-stage, TNBC subset) [Срок оценки: Up to approximately 115 months]
Distant Progression or Distant Recurrence-Free Survival (DPDRFS) [Срок оценки: Up to approximately 92 months]
Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status-Quality of Life Score [Срок оценки: Baseline and up to approximately 3 years]
Change from Baseline in EORTC QLQ-C30 Physical Functioning Score [Срок оценки: Baseline and up to approximately 3 years]
Change from Baseline in EORTC QLQ-C30 Role Functioning Score [Срок оценки: Baseline and up to approximately 3 years]
Change from Baseline in EORTC QLQ-C30 Fatigue Score [Срок оценки: Baseline and up to approximately 3 years]
Change from Baseline in EORTC QLQ Breast Cancer 42 (BR42) Systemic Therapy Side Effects Score [Срок оценки: Baseline and up to approximately 3 years]
Number of Participants Who Experience One or More Adverse Events (AEs) [Срок оценки: Up to approximately 67 weeks]

Критерии участия

Критерии включения

The main inclusion criteria include but are not limited to the following:

Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per AJCC 8th edition criteria as assessed by the physician investigator based on radiological and/or clinical assessment:

cT1c, N1-N2
cT2, N0-N2
cT3, N0-N2
cT4a-d, N0-N2
The participant must have a centrally confirmed diagnosis of BC that is triple-negative or HR-low+/HER2- (defined as estrogen receptor (ER)-low+ expression in 1% to 10% cells and HER2- as by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
Provides a core needle biopsy from the primary breast tumor at screening to the central laboratory.
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 28 days before Cycle1 Day 1 (C1D1).
Demonstrates adequate organ function.

Критерии исключения

The main exclusion criteria include but are not limited to the following:

Metastatic (Stage IV) breast cancer or clinical node stage 3 (cN3) nodal involvement
Has received any prior treatment, including radiation, systemic therapy,and/or definitive surgery for currently diagnosed breast cancer
Has undergone excisional biopsy of the primary tumor, axillary lymph node dissection, and/or axillary sentinel lymph node biopsy prior to study treatment.
Received prior systemic anticancer therapy including investigational agents within 4 weeks before C1D1.
Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX- 40, CD137).
Received prior treatment with a TROP2-targeted antibody-drug conjugate (ADC).
Received prior treatment with a topoisomerase I inhibitor-containing ADC.
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
Known additional malignancy that is progressing or has required active treatment within the past 5 years.
Uncontrolled systemic disease.
History of (noninfectious) pneumonitis/interstitial lung disease that required steroids, has current pneumonitis/interstitial lung disease or has suspected interstitial lung disease (ILD) or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening..

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: Открытое
Основная цель: Лечение