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

NCT04370522 | Terminated

• 1 other identifier: GEICAM/2018-03
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Metastatic Breast Cancer

Keywords

Luminal; HER2 negative; Endocrine therapy resistance

Outcome Measures

Primary Outcomes (3)

• Amount of innate immune cells

  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.

  Up to disease progression, an average of 25 months

• Activation level of innate immune cells

  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.

  Up to disease progression, an average of 25 months

• Analyses of the expression level of cytokines and/or rNKG2D ligands

  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.

  Up to disease progression, an average of 25 months

Secondary Outcomes (3)

• Progression Free Survival (PFS) in relation with values of innate immune cells, cytokines and ligands of rNKG2D

  Up to disease progression, an average of 25 months

• Objective Response Rate (ORR) in relation with values of innate immune cells, cytokines and ligands of rNKG2D

  Up to disease progression, an average of 25 months

• Clinical Benefit (CB) in relation with values of innate immune cells, cytokines and ligands of rNKG2D

  Up to disease progression, an average of 25 months

Study Arms (2)

Cohort A: hormone-sensitive disease

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.

Cohort B: hormone-resistant disease

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Luminal/HER2 negative advanced Breast Cancer patients and a control group of healthy women (premenopausal and postmenopausal).

You may not qualify if:

• Female ≥ 18 years of age on day of signing informed consent.
• Patient with histological confirmation of BC with evidence of metastatic or advanced disease not amenable to resection or radiation therapy with curative intent.
• Documented Hormonal Receptor (HR) positive status based on local testing (preferably assessed on the most recent tumour biopsy available). HR+ is defined as ≥ 1% positive cells by immuno-histochemistry (IHC) for ER and/or Progesterone Receptor (PgR).
• Documented HER2 negative status based on local testing (preferably assessed on the most recent tumour biopsy available). HER2- is defined as IHC score 0/1+ or negative by in situ hybridization according to local criteria.
• Patients who have participated in the study during their first line of ET are eligible to participate again when they receive the second line of ET (in this case eligibility criteria should be checked newly and ICF signed again).
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
• Patient must have a life expectancy ≥ 16 weeks.
• The patient has signed and dated the ICF for study participation.
• Willingness and ability to comply with the protocol for the duration of the study including biological sample collection.
• Have received more than 1 prior therapy line for advanced BC disease.
• Have received chemotherapy with response and initiate ET as maintenance treatment.
• Locally advanced breast cancer.
• Previous or concomitant treatment with immunotherapeutic agents.
• Major surgical procedure unrelated to breast cancer or significant traumatic injury within 28 days prior to study entry.
• History of concurrent or previously treated non-breast malignancies except for appropriately treated 1) non-melanoma skin cancer and/or 2) in situ carcinomas, including cervix and colon.

Sponsors & Collaborators

• Spanish Breast Cancer Research Group: lead

Study Sites (2)

Hospital General Universitario Morales Meseguer

Murcia, 30008, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Related Links

• GEICAM is the Spanish Breast Cancer Research Group

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, Peripheral Blood Mononuclear Cells and tumor tissue.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Study Director

  Hospital General Universitario Morales Meseguer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: May 1, 2020
• Study Start: May 21, 2021
• Primary Completion: March 24, 2025
• Study Completion: March 24, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

ES (2)