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Breast Diseases

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Hormones

Patients who initiate ET in first line of advanced disease, they could be patients de novo with no previous ET or patients who received adjuvant ET and experience disease recurrence more than one year after its completion.

Patients will be divided in two subgroups according to having or not received previous ET.

Patients in progression who are starting a first or second line of ET for advanced Breast Cancer (BC) and showing one of following the hormone-resistance criteria to any ET:

For first line:

* Primary hormone-resistance: disease recurrence occurs within the first two years of adjuvant ET.
* Secondary hormone-resistance: disease recurrence occurs after the first two years of adjuvant ET or during the first year after its completion.

For second line:

* Primary hormone-resistance: disease progression occurs within the first 6 months of ET for advanced disease.
* Secondary hormone-resistance: disease progression occurs after the first 6 months of ET for advanced disease.

Patients will be divided in two subgroups according to having primary or secondary hormone-resistance.

Study Director

This is a multicentre, prospective, observational, no post-authorization study. This study will be opened for recruitment approximately for 12 months for a pilot phase including at least 25-30 patients and 6 controls and for 12 additional months to complete patient and control inclusion until 90 patients and 20 control depending on the first part study results.

After enrolment, patients will be assigned to one of the following cohorts according to their level of hormone-resistance:

* Cohort A (hormone-sensitive disease).
* Cohort B (hormone-resistant disease).

In both cohorts it will be collected residual pre-treatment tumor samples from metastatic lesions, preferably obtained after last treatment just prior to study entry, and/or primary breast tumor; as well as serial blood samples at baseline, after 6 weeks, at the same time of radiological re-evaluation (3 months after ET initiation) and at progressive disease (PD) which will be used for serial analytic determinations of the expression profiles of Natural Killer (NK) cells, other lymphoid innate cells, NKG2D ligands, cytokines and other possible biomarkers; in addition to obtain local data of hemogram and estradiol, Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) levels.

Patients who have participated in the study during their first line of ET are eligible to participate after progression, when they initiate the second line of ET (in this case, inclusion/exclusion criteria should be checked newly and Informed Consent Form (ICF) signed again).

From the control population it will be collected blood and local data (e.g. hemogram, estradiol, FSH and LH levels), in a single time-point after ICF signature.

Plasma, Peripheral Blood Mononuclear Cells and tumor tissue.

Characterization of Innate Immune System in Patients With Luminal Advanced Breast Cancer

The NIKOLE Study: Characterization of Innate Immune System in Patients With Luminal Advanced Breast Cancer

Amount of the different populations of innate immune cells (e.g. NK cells, ILC1, ILC2 and ILC3) detected in tumor tissue and/or serial peripheral blood samples.

Blood samples will be collected from the patients at the following time-points: at baseline, after 6 weeks, at tumor re-evaluation of treatment and after end of therapy (before the beginning of the next treatment).

Blood samples will be collected from the control participants in a single time-point after signature of the corresponding Inform Consent Form.

It is required the shipment of residual pre-treatment tumor samples (leftover from medical routine assistance) from primary and/or the recurrence/metastatic sites, preferably obtained after the last treatment prior to study entry.

Activation level of the different populations of innate immune cells (e.g. NK cells, ILC1, ILC2 and ILC3) detected in tumor tissue and/or serial peripheral blood samples.

Blood samples will be collected from the patients at the following time-points: at baseline, after 6 weeks, at tumor re-evaluation of treatment and after end of therapy (before the beginning of the next treatment).

Blood samples will be collected from the control participants in a single time-point after signature of the corresponding Inform Consent Form.

It is required the shipment of residual pre-treatment tumor samples (leftover from medical routine assistance) from primary and/or the recurrence/metastatic sites, preferably obtained after the last treatment prior to study entry.

Analyses of the expression level of cytokines and/or rNKG2D ligands in tumor tissue and/or serial peripheral blood samples.

Blood samples will be collected from the patients at the following time-points: at baseline, after 6 weeks, at tumor re-evaluation of treatment and after end of therapy (before the beginning of the next treatment).

Blood samples will be collected from the control participants in a single time-point after signature of the corresponding Inform Consent Form.

It is required the shipment of residual pre-treatment tumor samples (leftover from medical routine assistance) from primary and/or the recurrence/metastatic sites, preferably obtained after the last treatment prior to study entry.

Progression Free Survival (PFS) defined as the time from the start of therapy to the first documented progressive disease, or death from any cause, whichever occurs first. Progressive disease will be based on the investigator's assessment according to the standard institutional guidelines, and following as much as possible RECIST version 1.1. Tumor assessment during treatment will be performed according the clinical standard of care and following as much as possible RECIST version 1.1. every 3 months (+/- 1 month).

OR rate (ORR) is defined as the Complete Response (CR) + Partial Response (PR) out of the patients who had measurable disease at baseline, according to the standard institutional guidelines and following as much as possible the RECIST version 1.1. Tumor assessment during treatment will be performed according the clinical standard of care and following as much as possible RECIST version 1.1. every 3 months (+/- 1 month).

Clinical Benefit (CB): is defined as complete response (CR), partial response (PR), or stable disease (SD) lasting more than 24 weeks; based on the investigator's assessment according to the standard institutional guidelines, and following as much as possible according to the RECIST version 1.1. The definition of Response/non-Response and Stable Disease will be based on the RECIST version 1.1. Tumor assessment during treatment will be performed according the clinical standard of care and following as much as possible RECIST version 1.1. every 3 months (+/- 1 month).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Characterization of Innate Immune System in Patients With Luminal Advanced Breast Cancer	NCT04370522	Metastatic Brea...		18 Years -	Spanish Breast Cancer Research Group
Characterization of Innate Immune System in Patients With Luminal Advanced Breast Cancer	NCT04370522	Metastatic Brea...		18 Years -	Spanish Breast Cancer Research Group

Spots Global Cancer Trial Database for endocrine therapy resistance