NCT04653740

Brief Summary

This is a monocentric cohort study, prospective and interventional with minimal risks and constraints for advanced breast cancer. The planned interventions are collection of biological samples at different times. The study will aim to do a descriptive analysis of omics profiles evolution (tumor, volatile organic components) over time, before and after disease progression under Palbociclib treatment with a clinical-biological database.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Sep 2020Jun 2026

Study Start

First participant enrolled

September 8, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

5.7 years

First QC Date

September 15, 2020

Last Update Submit

March 16, 2026

Conditions

Advanced Breast Cancer

Keywords

breast canceromics profilesproteomicsvolatile organic compoundsexosomes

Outcome Measures

Primary Outcomes (2)

  • Intrapatient variation in molecular profiles at progression compared to baseline

    Variation over time in the rate of VOCs in response to treatment and in progression situations.

    From date of inclusion until the date of first documented progression (around 2 years)

  • longitudinal changes in VOCs profile and exosomes according to response to treatment

    variation over time in exosomes count in response to treatment and in progression situations

    From date of inclusion until the date of first documented progression, assessed up to 2 years

Secondary Outcomes (2)

  • Proportion of alterations / molecular signatures unique or shared between patients at progression

    At progression time, up to 2 years

  • Correlation between tumor signatures, VOCs and exosomes

    At progression time, up to 2 years

Other Outcomes (7)

  • Concordance between molecular changes identified by proteomics and those observed by genomics/transcriptomics

    At progression time, up to 2 years

  • Describe the evolution of VOCs and exosomes over time in relation to the evolution of liquid biopsy markers (CA15.3)

    At progression time, up to 2 years

  • Describe the evolution of VOCs and exosomes over time in relation to the evolution of liquid biopsy markers (CA15.3)

    At progression time, up to 2 years

  • +4 more other outcomes

Interventions

specimen sample collectionPROCEDURE

Before and during treatment, and at progression, collection of : * Blood * Exhaled air * Saliva * Sweat * Tears * Urine

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale with breast cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women over 18 years old
  • With histologically proven breast cancer, positives hormones receptors and negative HER2
  • Advanced disease (metastases or non-resequable locoregional disease), from the 1st to the 4th line.
  • With an indication for hormone therapy associated with the CDK4/6 inhibitor Palbociclib
  • Agree to the sampling of the study
  • Signed the informed consent form

You may not qualify if:

  • Neoadjuvant or adjuvant treatment for localized breast cancer
  • Metastatic breast cancer beyond the forth line
  • Impossibility to give informed consent (person deprived of liberty or under guardianship)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Oscar Lambret

Lille, France, 59020, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2020

First Posted

December 4, 2020

Study Start

September 8, 2020

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Locations

FR(1)