Идёт набор NCT05952557

An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)

Фаза III С лечением Breast Cancer, Early 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: Camizestrant, Tamoxifen, Anastrozole, Letrozole.
Кому может быть актуально: Состояния в реестре: Breast Cancer, Early Breast Cancer. Базовые параметры: 18 лет — 130 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, Австрия, Бельгия +39
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

CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+/HER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease

Обзор

Подробное описание

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs).

Patients will be followed for 10 years from randomization of the last patient.

Вмешательства

Препарат Camizestrant
Camizestrant. Experimental. Administered orally
Препарат Tamoxifen
Tamoxifen. Comparator. Administered orally
Препарат Anastrozole
Anastrozole. Comparator. Administered orally
Препарат Letrozole
Letrozole. Comparator. Administered orally
Препарат Exemestane
Exemestane. Comparator. Administered orally
Препарат Abemaciclib
Abemaciclib adjuvant treatment Administered orally

Первичные конечные точки

Invasive breast cancer-free survival (IBCFS) [Срок оценки: Up to 14 years]

Вторичные конечные точки (7)

Invasive disease-free survival (IDFS) [Срок оценки: Up to 14 years]
Distant relapse-free survival (DRFS) [Срок оценки: Up to 14 years]
Overall survival (OS) [Срок оценки: Up to 14 years]
Incidence and Severity of Adverse Events, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0) [Срок оценки: Until 28 days after the final dose of study treatment (up to 7 years)]
Proportion of time on study treatment with high side-effect burden as measured by the PGI-TT. [Срок оценки: Until 28 days after the final dose of study treatment (up to 7 years)]
Change from baseline and time to deterioration of health-related quality of life as measured by the 2 global QoL items from the EORTC IL-311 [Срок оценки: Until 28 days after the final dose of study treatment (up to 7 years)]
Pharmacokinetics (PK) [Срок оценки: Until 6 months from treatment start]

Критерии участия

Критерии включения

Women and Men; ≥18 years at the time of screening (or per national guidelines)
Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with absence of any evidence of metastatic disease as defined in the protocol.
Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy.
Patients must be randomised within 12 months of definitive breast surgery.
Patients may have received up to 12 weeks of endocrine therapy prior to randomisation.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
Adequate organ and bone marrow function

Критерии исключения

Inoperable locally advanced or metastatic breast cancer
Pathological complete response following treatment with neoadjuvant therapy
History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix or considered a very low risk of recurrence per investigator judgement) unless in complete remission with no therapy for a minimum of 5 years from the date of randomisation
Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion precludes participation in the study or compliance "
Known LVEF <50% with heart failure NYHA Grade ≥2.
Mean resting QTcF interval > 480 ms at screening
Concurrent exogenous reproductive hormone therapy or non topical hormonal therapy for non-cancer-related conditions
Any concurrent anti-cancer treatment not specified in the protocol with the exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors ( eg, denosumab)
Previous treatment with camizestrant, investigational SERDs/investigational ER targeting agents, or fulvestrant
Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding.
Patients with known hypersensitivity to active or inactive excipients of camizestrant or drugs with a similar chemical structure or class to camizestrant. In pre-/peri-menopausal female and male patients, known hypersensitivity or intolerance to LHRH agonists that would preclude the patient from receiving any LHRH agonist.

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