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This is a translational project investigating the causes of resistance to hormonal therapy in patients with estrogen receptor (ER)-positive, HER2-negative metastatic breast cancer. Women aged 18 and older with metastatic ER-positive breast cancer who are candidates for first-line hormonal therapy can take part. It has no assigned phase and is currently recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Histologically proven diagnosis of adenocarcinoma of the breast with evidence of metastatic disease. * ER positive tumor ≥ 1% * HER2 negative breast cancer by FISH or IHC (IHC 0,1+, 2+ and/or FISH HER2: CEP17 ratio \< 2.0) * Females, 18 years of age or older * Candidate to first-line endocrine therapy (LH-RH analogue for pre-menopausal women is allowed) * Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment. * Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures. Exclusion Criteria: * Diagnosis of any secondary malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix. * Prior endocrine therapy for metastatic disease * Prior chemotherapy for metastatic disease * Patients unwilling to or unable to comply with the protocol. * Known CNS metastases