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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSpanish Breast Cancer Research Group

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients (males or females) diagnosed with unresectable locally advanced or MBC (either after a recurrence or as first diagnosis) from January 2016 onwards.

Patients who died are allowed to be included on the study.

Able and willing to provide written informed consent if they are alive.

Age ≥ 18 years.

Disqualifiers

None

Trial population

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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

Treatment groups

1,867 Participants
are divided into 5 treatment groups
Group A: Luminal A-like subtype1 intervention
Group B: Luminal B-like (HER2 negative) subtype:1 intervention
Group C: Luminal B-like (HER2 positive) subtype:1 intervention
Group D: HER2-enriched subtype1 intervention
Group E: Triple Negative (TN) subtype1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
8 years

Secondary outcomes

1

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.

Time frame
8 years
2

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.

Time frame
8 years
3

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

Time frame
8 years
4

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.

Time frame
8 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Spanish Breast Cancer Research Group

Lead sponsor

Hoffmann-La Roche

Collaborator

Novartis

Collaborator

AstraZeneca

Collaborator

Pfizer

Collaborator

Celgene

Collaborator