An observational study in Breast Cancer, sponsored by Azienda Ospedaliero-Universitaria di Modena. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-03.
Sponsored by Azienda Ospedaliero-Universitaria di Modena · Observational
The primary goal of this observational study is to describe the distribution of treatment options and patients' characteristics according to the definition of high-risk status in the early breast cancer (EBC) setting. Participants already taking intervention as part of their regular medical care for EBC will answer questionnaires to also assess quality of life and patient reported outcomes.
The recruitment phase will last about 2 years, each patient will be followed up for 5 years.
The treatment of high-risk hormone receptor (HR) positive, Her2 negative, early breast cancer (EBC) patients has recently changed following the results of practice changing phase III trials. The hormone therapy (HT) with tamoxifene (T) or Aromatase Inhibitors (AIs), in association with ovarian function failure suppression (OFS) in the premenopausal patients, represented the standard options available until 2022. The role of OFS, usually reached through the use of LhRh analogues in the premenopausal patients, was addressed and defined in the SOFT/TEXT trials. The association of LhRh analogues (LhRha) with exemestane (E) or T with LhRha in the premenopausal setting showed an improved disease free survival (DFS) if compared to T alone. Moreover, at 12 years of follow up, the E-LhRha increases the DFS if compared to T-LhRha3. In the SOFT study, premenopausal patients did not benefit from the addition of OFS, but for whose women at sufficient risk of recurrence to deserve adjuvant chemotherapy (CHT) and who maintained pre-menopausal estradiol, the addition of LhRha to T reduced the risk of recurrence. Moreover, the TEXT trial, adjuvant endocrine therapy with exemestane (E) plus LhRha, as compared with tamoxifen plus LhRha, significantly improved disease-free survival (DFS), breast cancer-free interval (BCFI) and distant disease-free survival (dDFS), thus representing a new treatment option for high-risk patients. The investigators of the SOFT and TEXT trials performed a combined secondary analysis to estimate the magnitude of absolute improvements in freedom from any recurrence (BCFI=breast cancer-free interval) according to quantitative composite measure of recurrence risk (hereafter referred to as "composite risk") defined by seven clinicopathologic characteristics.
Based on the results of MonarchE study, with the adjunct of Abemaciclib to the standard HT, the European Medicine Agency (EMA) recently approved Abemaciclib for the adjuvant treatment of high-risk EBC in combination with AI or T in the adjuvant setting. Moreover the results of OlympiA study highlights the role of Olaparib in the high-risk HR positive, Her2 negative, BRCA mutated, EBC patients. Based on the results of Olympia trial, Olaparib was approved for HR positive, HER2-negative patients who must have ≥4 pathologically confirmed positive lymph nodes or must have a CPS\&EG score of ≥3 based on pre-treatment clinical and post-treatment pathologic stage (CPS), estrogen receptor (ER) status and histologic grade 8,9. Moreover Ribociclib recently has demonstrated activity in the phase III trial but a longer follow up will be needed to confirm the early results.
In this retrospective/prospective observational trial, we would like to assess the pattern of size in the high-risk HR positive, Her2 negative early breast cancer patients including BRCA mutated patients. Patients already taking intervention as part of their regular medical care for EBC must signed an informed consent in order to be recruited. After the patient has signed the informed consent for the participation in the study, data on the demographic and clinic-pathological characteristics obtained from the patients' computerized medical records will be collected and entered into an anonymized database. Questionnaires will also be administered to prospectively enrolled patients in order to evaluate quality of life and patient reported outcomes.
The recruitment phase will last about 2 years, each patient will be followed up for 5 years.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 100 is below the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Azienda Ospedaliero-Universitaria di Modena is the lead sponsor of 48 studies on the registry; 20 are open to participants now.
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High-risk HR positive, HER2 negative, early breast cancer patients admitted to the Oncology department at the University Hospital of Modena.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
High-risk HR positive, Her2 negative early breast cancer patients with one of the following characteristics:
Anatomical stage IIA N0 with:
Pathological tumour involvement in 1 to 3 ipsilateral axillary lymph node(s) (for patients who received therapy also cytological tumour involvement at time of initial diagnosis is allowed) and meet at least 1 of the following criteria:
BRCA mutated populations
Patients must be node positive and fulfil one of the following criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
High-risk HR positive, Her2 negative early breast cancer patients receiving abemaciclib, olaparib and endocrine therapy.
Drug: abemaciclib, olaparib and endocrine therapy
Drug pages: Abemaciclib · Olaparib
Patients receiving abemaciclib, olaparib and endocrine therapy.
Distribution of treatment options
Type of adjuvant treatment chosen
Time frame: From enrollment to the end of treatment at 5 years
Plan to share: No
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Azienda Ospedaliero-Universitaria di Modena