Meme Kanserinde CDK4/6 İnhibitörlerine Karşı Birincil Direncin Belirlenmesi

Sade dilde özet

Bu çalışma, metastatik meme kanseri (metastatic breast cancer) olan hastalarda CDK4/6 inhibitörlerine karşı gelişen birincil (erken) direnci belirlemek amacıyla timidin kinaz aktivitesini incelemektedir. Çalışmaya, östrojen reseptörü pozitif (ER-positive) ve HER2 negatif hastalığı olan, ilk kez bir aromataz inhibitörü ve CDK4/6 inhibitörü tedavisi alacak 18 yaş ve üzeri kadınlar katılabilmektedir. Faz uygulanmayan bu çalışma yürütülmekte ve halen katılımcı almaktadır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

N/A

Durum

Katılımcı alıyor

Sponsor

Fondazione Sandro Pitigliani

Müdahale

Thymidine kinase activity

Başlangıç

01.09.2020

Tahmini bitiş

01.12.2026

Ülkeler

Italy

İlgili genler

Merkezler

• Prato, Italy

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

1. Women aged 18 years or older, with a diagnosis of metastatic breast cancer
2. ER-positive and HER2-negative disease as assessed locally either on primary tumor tissue or on a biopsy of a metastasis
3. The patient has not received any prior systemic therapy for metastatic breast cancer (may have received prior hormonal therapy or chemotherapy in the neo/adjuvant setting)
4. The patient is candidate to receive first-line therapy with an aromatase inhibitor (AI) and a CDK4/6 inhibitor per local clinical practice
5. The patient must have evaluable disease according to RECIST 1.1 (either measurable or non-measurable).

   Note: Patients with bone-only disease will be allowed in a specific sub-cohort, which will comprise 10% of the total sample size.
6. Hystologic material from one formalin-fixed, paraffin-embedded (FFPE) tumor block from a diagnostic core or excisional biopsy of a metastatic lesion, taken before study entry must be provided (patients with bone-only disease will be accepted into the trial without a biopsy of the metastatic site). Hystologic material from an additional biopsy (core or excisional) taken at time of disease progression on the study treatment must also be provided, if clinically feasible. When available, hystologic material from an FFPE tumor block from the primary breast cancer must also be submitted.
7. The patient agrees to provide blood samples. at the trial specified time points

Exclusion Criteria:

1. Patients with metastatic disease isolated to the central nervous system (CNS) without metastatic involvement of any other site, unless surgical excision of CNS metastasis has been performed and the tumor tissue is available for the study.
2. Previous or current non-breast malignancies within the last 5 years, with the exception of in situ carcinoma of the cervix and/or adequately treated basal cell or squamous cell carcinoma of the skin