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Идёт набор NCT07340541

Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies

Фаза II С лечением Breast Cancer Metastatic Breast Cancer Triple Negative Breast Cancer Estrogen-receptor-positive Breast Cancer

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: SERD* + abemaciclib, SERD* + everolimus, SERD* + everolimus or capecitabine, SOC.
Кому может быть актуально
Состояния в реестре: Breast Cancer, Metastatic Breast Cancer, Triple Negative Breast Cancer, Estrogen-receptor-positive Breast Cancer. 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
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

TBCRC Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies (EVOLVE-BDT)

Обзор

This is a multicenter, multi-arm, biomarker-stratified trial designed to evaluate biomarker-directed therapies in patients with estrogen receptor-positive/hormone receptor-negative (ER+/HR-) and triple-negative (TN) metastatic breast cancer (MBC). The trial integrates both retrospective and prospective data collection, including archival tumor tissue, medical record abstraction, and prospective tumor and blood sampling prior to initiation of protocol directed treatment. Based on biomarker subtype, participants will receive standard of care therapy. Liquid biopsy will be collected on Cycle 2 Day 1, and then liquid biopsy, imaging and clinical data will be collected at each re-staging. Treatment will continue until discontinuation for progression, toxicity or at the discretion of the treating physician.

Подробное описание

The platform design makes it easy to assess multiple targeted therapies at the same time, focusing on patient groups identified by specific biomarkers. Patients who experience disease progression may be reassigned to additional eligible sub trials evaluating alternative therapeutic options. The primary endpoint for each arm is progression-free survival (PFS). This adaptive framework enables continuous learning and rapid translation of biomarker discoveries into therapeutic evaluation, promoting an agile and data-driven approach to treatment optimization in advanced breast cancer.

Beyond ER and HER2, there are few biomarkers to drive treatment decisions in metastatic and primary breast cancer, leaving a gap in effective treatments for other subtypes. To address this, triple-negative (TNBC) is pioneering an adaptive, evolutionary trial focusing on women with metastatic breast cancer (MBC) in the second-line (2L) setting. The adaptive trial infrastructure is designed to serve as an integrated parent study, enabling coordinated acquisition of clinical and translational data, as well as training and testing activities. Within this framework, individual biomarker-driven sub-trials (based on biomarker development) can be created and conducted.

Eligible participants include patients with ER+/HER2- or triple-negative (TNBC) metastatic breast cancer (MBC) who have progressed on first line (1L) therapy but have not yet initiated second-line (2L) treatment. HER2+ patients will be excluded due to the availability of established effective therapies.

This Sub Protocol #1 will enroll subjects based on biomarker subtype. Participants will receive a standard of care therapy. Liquid biopsy will be collected on Cycle 2 Day 1, and then liquid biopsy, imaging and clinical data will be collected at each re-staging. Treatment will continue until discontinuation for progression, toxicity or at the discretion of the treating physician. In order to participate in Sub Protocol #1 subjects must have consented to the Parent protocol.

Вмешательства

  • Препарат SERD* + abemaciclib
    Investigators choice Selective Estrogen Receptor Degrader + abemaciclib therapy.
  • Препарат SERD* + everolimus
    Investigators choice Selective Estrogen Receptor Degrader + everolimus therapy.
  • Препарат SERD* + everolimus or capecitabine
    Investigators choice Selective Estrogen Receptor Degrader + everolimus or capecitabine therapy.
  • Препарат SOC
    standard-of-care (SOC) chemotherapy in breast cancer
  • Препарат Antiandrogen
    Antiandrogen therapy

Первичные конечные точки

  • Intra-Individual Progression-Free Survival (PFS) [Срок оценки: Up to 5 years]
Вторичные конечные точки (12)
  • Progression free survival (PFS) - Between-Arm Evaluation [Срок оценки: Up to 3 months]
  • Tissue- and blood-based biomarkers on response rate [Срок оценки: Up to 3 months]
  • Overall survival (OS) [Срок оценки: Up to 12 months]
  • Objective response rate (ORR) [Срок оценки: Up to 3 months]
  • Duration of response (DoR) [Срок оценки: Up to 12 months]
  • Clinical benefit rate (CBR) [Срок оценки: Up to 12 months]
  • Grade 2 or above Adverse Events per NCI Common Terminology Criteria for Adverse Events (CTCAE) [Срок оценки: Up to 12 months]
  • Changes in circulating tumor DNA (ctDNA) levels [Срок оценки: Up to 12 months]
  • Changes in transcriptomic data - tissue [Срок оценки: Up to 12 months]
  • Changes in transcriptomic data - blood [Срок оценки: Up to 12 months]
  • Changes in Circulating tumor DNA (ctDNA) and tumor response relation [Срок оценки: Up to 12 months]
  • Progression free survival (PFS) -Within Arm Evaluation [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

  • Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
  • Subject is willing and able to comply with study procedures based on the judgement of the investigator.
  • Age ≥ 18 years of age at the time of consent
  • ECOG Performance Status of 0-2 (see APPENDIX A: ECOG Performance Status Scale).
  • Patients must fulfill all eligibility criteria outlined in the LCCC2521 Parent Protocol and consented to LCCC2521 Parent Protocol

Критерии исключения

  • Inaccessible metastatic lesion to research biopsy
  • Subject has already initiated 2nd line therapy
  • Concurrent disease or condition that in the opinion of the treating oncologist renders the patient inappropriate for study participation

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 4 центра
  • Yale Cancer Center Clinical Trials Office — New Haven
  • Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore
  • Mayo Clinic — Rochester
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill — Chapel Hill

Идентификаторы

NCT: NCT07340541 · LCCC2521-TBCRC-073(EVOLVE-BDT) · 140D042590009

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗