A Prospective Registry Study in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer (MBC)

Study Overview
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Brief Summary
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This study is a prospective, multicenter non-interventional cohort study designed to develop a registry in unresectable locally advanced or metastatic disease.

Detailed Description
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The target population for inclusion in this study is breast cancer patients recently diagnosed (from January 2016) with unresectable locally advanced or metastatic disease (either after a recurrence or as first diagnosis). No treatment regimen will be protocol specified. This is an observational study in which clinical decisions concerning the optimum management strategy for a particular patient are taken independently of and/or prior to, any decision by the physician to invite a patient to participate in the study. The treating physician will make all treatment decisions according to his/her regular clinical practice independent of this study. Patients enrolled on the study are free to withdraw their informed consent for the use and disclosure of health information at any time and when asked, patients are not obliged to provide a reason. Patients may request discontinuation from the study at any time. The date and the reason for withdrawal or discontinuation from the study must be recorded in the electronic case report form (eCRF). An attempt will be made to determine the date of discontinuation and final status (i. e. withdrawal of consent, loss to follow-up, death) of any patient who discontinues from the study. However, the treating clinician is encouraged to follow the patient as long as possible, until patient death or through study end. The Sponsor has the right to terminate the study at any time. The Sponsor will notify the investigator if the study is placed on hold or if the Sponsor decides to discontinue the study.

Official Title
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A Prospective Registry Study in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer (MBC)

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients (males or females) diagnosed with unresectable locally advanced or MBC (either after a recurrence or as first diagnosis) from January 2016. Able and willing to provide written informed consent. Age ≥ 18 years. Availability to medical records access and all data related to the disease management. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Luminal A-like subtype<br>Patients that express Estrogen receptor (ER), express Progesterone Receptor (PgR)+ (≥ 20%), don't express HER2 and have Ki-67 'low' (< 14%). | Other: No intervention<br> <br> |
| Luminal B-like (HER2 negative) subtype:<br>Patients that express ER and are either PgR- or low (< 20%) and/or Ki67 'high' (≥ 14%). | Other: No intervention<br> <br> |
| Luminal B-like (HER2 positive) subtype:<br>Patients that express ER and HER2 irrespective of PgR or Ki67 status. | Other: No intervention<br> <br> |
| HER2-enriched subtype<br>Patients that express HER2 and don't express ER or PgR. | Other: No intervention<br> <br> |
| Triple Negative (TN) subtype<br>Patients who are negative for the expression of ER, PgR and HER2. | Other: No intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with the different breast cancer subtypes and real distribution of them. | Number of patients with the different breast cancer subtypes (Luminal A-like, Luminal B-like [HER2 negative], Luminal B-like [HER2 positive], HER2-enriched and Triple Negative) of the unresectable locally advanced or metastatic disease | 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient and tumor characteristics and frequency of breast cancer with heredofamiliar risk. | It will be performed a table with patient and tumor characteristics including only those patients with heredofamiliar risk. | 8 years | 
| Differences in the development disease in the group of male vs female patients. | It will be performed an analysis separately for each subtype and by male and female and it will analyse if there are any significative difference between them. | 8 years | 
| Influence of timing of primary tumor surgery in patients with metastatic disease as first diagnosis | Influence of timing of primary tumor surgery in patients with metastatic disease as first diagnosis | 8 years | 
| Number of participants with specific biomarkers on tumor and blood samples. | to improve the understanding of metastatic breast cancer by performing analysis on tumor and blood samples. | 8 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unresectable, locally, advanced, metastatic disease