Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study

Recruiting Observational Study
Breast Adenocarcinoma Breast Cancer Stage IV Breast Cancer, Metastatic Breast Carcinoma Breast Diseases Breast Neoplasms Breast Neoplasms, Male Breast Cancer Breast Cancer With Metastatic Bone Disease Breast Cancers Breast Neoplasm Breast Tumors HR+ HER2- Men, Pre/Postmenopausal Advanced Breast Cancer HR+ Advanced or Metastatic Breast Cancer HR+/HER2- Breast Cancer HRpos Breast Neoplasms HR-positive, HER2-negative Advanced Breast Cancer HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer HR-positive Breast Cancer Hormone Receptor-Positive Breast Cancer Hormone Receptor Positive Breast Adenocarcinoma Hormone Receptor Positive Breast Carcinoma Hormone Receptor Positive Breast Neoplasms Hormone Receptor Positive HER-2 Negative Breast Cancer Hormone Receptor Positive Malignant Neoplasm of Breast Hormone Receptor Positive Metastatic Breast Cancer Hormone Receptor Positive, HER2 Negative Breast Cancer Hormone Receptor Negative Breast Cancer Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer Hormone Receptor Positive Breast Cancer Hormone Receptor Positive (ER+/PR+, and Her2-) Metastatic Breast Cancer Hormone Receptor Positive, HER2-negative Neoplasms Hormone Receptor Positive, HER2-low Neoplasms Hormone Receptor Positive (HR+), HER2-negative Breast Cancer Hormone Receptor (HR)-Positive Breast Cancer Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer Palbociclib Ribociclib Abemaciclib CDK4/6 Inhibitor CDK4/6 Inhibitors
No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
3,500 (estimated)
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Other
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About This Trial
PALMARES-2 is a retrospective/prospective, observational, multicenter, population-based study, aiming at providing real-world evidences on HR+/HER2- aBC patients treated with first-line CDK4/6i plus ET. The present study has the objective to collect data coming from different sources, i.e. RWD, medical images and biological samples, from patients treated with CDK4/6i as first-line of therapy for H…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Diagnosis of HR+/HER2- advanced Breast Cancer (aBC), as defined as at least 1% estrogen receptor (ER) and/or progesterone receptor (PgR) positivity at IHC. HER2 negativity is defined on the basis of an IHC score of 0, 1+, or 2+ with absence of gene amplification at in situ hyb…
Contacts

Claudio Vernieri, M.D., Ph.D.

+390223903066

claudio.vernieri@istitutotumori.mi.it

CONTACT