Идёт набор NCT06800612

Evaluating Efficacy and Tolerability of Anticancer Drug Therapies for the Treatment of Gynecologic and Breast Cancers

— Наблюдательное Breast Cancer Early Stage Breast Cancer (Stage 1-3) Breast Cancer Metastatic Ovarian Cancer Cervical Carcinoma

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: Oncologic drugs administered for treatment of breast cancer, Oncologic drug administered for treatment of gynecologic cancer.
Кому может быть актуально: Состояния в реестре: Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Metastatic, Ovarian Cancer, Cervical Carcinoma. 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: Италия
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

Observational Study Evaluating the Efficacy and Tolerability of Anticancer Drug Therapies Adopted for the Treatment of Gynecologic and Breast Cancers in Clinical Practice Compared with the Results of Registration Studies

Обзор

retrospective/prospective observational study. Objective of the study is to evaluate the effect of drugs in terms of objective responses, disease-free survival (DFS), progression-free survival (PFS), overall survival (OS), and side effects compared with registry studies in the medical therapy of breast and gynecologic cancers.

Подробное описание

This is a single-center retrospective/prospective observational study. Objective of the study is to evaluate the effect of drugs in terms of objective responses, disease-free survival (DFS), progression-free survival (PFS), overall survival (OS), and side effects compared with registry studies in the medical therapy of breast and gynecologic cancers.

Regarding the prospective component of the study, it is clarified that therapy will be warranted by clinical practice regardless of study enrollment. Diagnostic investigations will also be conducted as per normal practice; enrollment in the study does not require additional examinations.

Вмешательства

Препарат Oncologic drugs administered for treatment of breast cancer
Data on oncologic drugs administered for treatment of breast cancer will be recorded
Препарат Oncologic drug administered for treatment of gynecologic cancer
Data on oncologic drugs administered for treatment of gynecologic cancer will be recorded

Первичные конечные точки

DFS [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.]

Вторичные конечные точки (3)

PFS [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.]
OS [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.]
Side effects [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.]

Критерии участия

Критерии включения

Diagnosis of histologically confirmed breast cancer or gynecological cancer, either early stage or metastatic;
Patients who have received treatment for breast cancer or gynecologic cancer since January 2010;
Any patient currently living and actually contactable must sign an informed consent to the study and processing of personal data.