Идёт набор NCT05977036

BettER: Biomarker Driven Early Therapeutic Selection in Patients With HR+ HER2- Metastatic or Unresectable Breast Cancer

Без фазы С лечением Metastatic Breast Cancer Unresectable 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: DiviTum® TKa assay, CDK4/6 + Endocrine therapy.
Кому может быть актуально: Состояния в реестре: Metastatic Breast Cancer, Unresectable 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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Обзор

This is a prospective study to assess the impact of biomarker driven, early therapeutic switching and delayed imaging with the incorporation of DiviTum® serum TK1 activity ("DiviTum® TKa") in patients with HR positive, HER-2 negative metastatic or unresectable breast cancer. Patients will receive first-line treatment with a CDK4/6 inhibitor (CDK4/6i) and endocrine therapy. All patients will have blood drawn for thymidine kinase activity (TKa) testing at baseline and at C1D15. Patients who are found to have a lack of TKa suppression at C1D15 will be recommended to switch to an alternative therapy. Patients with suppressed C1D15 TKa levels will continue on CDK4/6i and endocrine therapy until clinical progression. Patients with TKa which remains suppressed will be recommended to delay restaging scans from 24 weeks to 36 weeks. The investigators hypothesize that a patient's TKa level at C1D15 is prognostic for progression-free survival (PFS) on a CDK4/6 inhibitor and early therapeutic switching in patients with a lack of C1D15 TKa suppression will be associated with prolonged PFS.

Вмешательства

Устройство DiviTum® TKa assay
Will be utilized for determination of serum enzymatic activity of TK1 according to the manufacturer's instructions
Препарат CDK4/6 + Endocrine therapy
FDA-approved endocrine therapy plus CDK4/6 inhibitor. Ribociclib is the preferred CDK4/6 inhibitor. In the event this drug cannot be obtained due to insurance authorization or if there are specific side effect profile concerns from the treating physician, an alternative CDK4/6 inhibitor is allowed.

Первичные конечные точки

Progression-free survival (PFS) in patients who remain on CKD4/6i (patients with suppressed TKa levels at cycle 1 day 15) [Срок оценки: Through completion of follow-up (estimated to be 7 years)]
Clinical benefit rate (CBR) in patients who remain on CDK4/6i [Срок оценки: Through completion of follow-up (estimated to be 7 years)]
Progression-free survival (PFS) in patients who switch to an alternate therapy (patients with unsuppressed TKa levels at cycle 1 day 15) [Срок оценки: Through completion of follow-up (estimated to be 7 years)]

Вторичные конечные точки (9)

Feasibility (compliance rate) in patients with suppressed TKa level at cycle 1 day 15 [Срок оценки: At 36 weeks]
Feasibility (compliance rate) in patients with unsuppressed TKa level at cycle 1 day 15 [Срок оценки: At Cycle 1 Day 15]
Baseline TKa level to predict overall survival (OS) on first-line CDK4/6i [Срок оценки: Through completion of follow-up (estimated to be 7 years)]
Baseline TKa level to predict overall survival (OS) on later lines of therapy [Срок оценки: Through completion of follow-up (estimated to be 7 years)]
Cycle 1 day 15 TKa level to predict overall survival (OS) on first-line CDK4/6i [Срок оценки: Through completion of follow-up (estimated to be 7 years)]
Cycle 1 day 15 TKa level to predict overall survival (OS) on later lines of therapy [Срок оценки: Through completion of follow-up (estimated to be 7 years)]
Cycle 2 day 1 TKa level to predict overall survival (OS) on first-line CDK4/6i [Срок оценки: Through completion of follow-up (estimated to be 7 years)]
Cycle 2 day 1 TKa level to predict overall survival (OS) on later lines of therapy [Срок оценки: Through completion of follow-up (estimated to be 7 years)]
Number of patients with TKa suppressed at cycle 1 day 15 who have stable disease on subsequent disease assessments [Срок оценки: Through 2 years]

Критерии участия

Inclusion Criteria - Patients

Diagnosis of metastatic or advanced unresectable invasive breast cancer that is hormone receptor-positive (HR+) and HER2-negative.
Planned to initiate standard of care first-line therapy with FDA-approved endocrine therapy plus CDK4/6 inhibitor for the stated diagnosis at the time of study enrollment. Ribociclib is the preferred CDK4/6 inhibitor. In the event this drug cannot be obtained due to insurance authorization or if there are specific side effect profile concerns from the treating physician, an alternative CDK4/6 inhibitor is allowed.
Any prior therapy for early stage breast cancer is allowed, including endocrine therapy and chemotherapy.
Prior receipt of adjuvant CDK 4/6 inhibitor therapy is permitted provided therapy completion occurred > 12 months prior to study enrollment.
Presence of RECIST-evaluable disease. Patients with bone-only disease are eligible.
At least 18 years of age.
ECOG performance status ≤ 2
Post-menopausal status, defined as one of the following:

Age ≥ 60 years
Age < 60 with intact uterus and amenorrhea for 12 consecutive months or more
Status post bilateral oophorectomy, total hysterectomy
Pre- or peri-menopausal with suppressed ovarian function by use of GnRH agonist/antagonist or surgical bilateral oophorectomy
Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria - Patients

Receipt of any prior cytotoxic chemotherapy line for metastatic disease. There will be no limit to chemotherapy use in the neoadjuvant or adjuvant setting.
Patients with a prior or concurrent malignancy are excluded unless that malignancy's natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Concurrent participation in any investigational therapeutic trial for treatment of metastatic breast cancer.

Eligibility Criteria - Physicians