NCT04638725

Brief Summary

This is a multicenter, non-randomized, prospective cohort study. The purpose of the study is to identify constitutional genetic factors associated with histological response, resistance or sensibility to treatment in human epidermal growth factor receptor 2 (HER2)-positive breast cancer. 9000 patients will be enrolled in this study. Blood samples will be collected after informed consent and inclusion in the study. Patients will be treated and followed according to the standards of their treating center. They will be followed every six months for five years.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
9,000

participants targeted

Target at P75+ for all trials

Timeline
43mo left

Started Dec 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Dec 2021Dec 2029

First Submitted

Initial submission to the registry

November 9, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 15, 2021

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2029

Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

8 years

First QC Date

November 9, 2020

Last Update Submit

August 2, 2022

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (3)

  • Pathologic Complete Response (pCR)

    Constitutional genetic variants using a genome-wide approach will be tested for association with pCR as a function of neoadjuvant treatment targeting HER2.

    at the end of enrollment (3 years)

  • Disease Free Survival (DFS)

    Constitutional genetic variants using a genome-wide approach will be tested for association with DFS as a function of treatment

    At the end of the study (8 years)

  • Overall Survival (OS)

    Constitutional genetic variants using a genome-wide approach will be tested for association with OS as a function of treatment

    At the end of the study (8 years)

Study Arms (5)

HER2 positive breast cancer treated only with trastuzumab

Other: Blood sample for genetic analysis

HER2 positive breast cancer treated with pertuzumab

Other: Blood sample for genetic analysis

HER2 positive breast cancer treated with neratinib

Other: Blood sample for genetic analysis

HER2 positive breast cancer treated with Trastuzumab emtansine (TDM1)

Other: Blood sample for genetic analysis

HER2 positive breast cancer treated with TDM1 and neratinib

Other: Blood sample for genetic analysis

Interventions

Blood sample for genetic analysisOTHER

Blood samples will be collected in two 6 ml EDTA tubes after informed consent and inclusion in the study

HER2 positive breast cancer treated only with trastuzumabHER2 positive breast cancer treated with TDM1 and neratinibHER2 positive breast cancer treated with Trastuzumab emtansine (TDM1)HER2 positive breast cancer treated with neratinibHER2 positive breast cancer treated with pertuzumab

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

HER2-positive Breast Cancer

You may qualify if:

  • Age ≥ 18 years
  • Histological diagnosis of breast adenocarcinoma. Non-metastatic and operable.
  • Current or prior treatment with one therapy targeting HER2 in adjuvant or neoadjuvant phase for the current breast cancer
  • Given written informed consent

You may not qualify if:

  • Patients not able to comply to the protocol assessments for geographic, social or psychological reasons
  • Patients placed under judicial protection, guardianship, or supervision
  • History of cancer in the 5 years preceding anti-HER2 therapy initiation
  • Concomitant cancer (except for an other non metastatic cancer treated only with surgery)
  • Note : Patients are eligible at any time of the follow-up if the adjuvant or neoadjuvant chemotherapy started after 01/01/2019. Patients treated with trastuzumab, pertuzumab, neratinib or T-DM1 in a clinical trial are eligible in the SIGHER study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de cancérologie Strasbourg Europe

Strasbourg, 67033, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood sample, Tumour paraffin-embedded sample

MeSH Terms

Interventions

Blood Specimen CollectionGenetic Testing

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Central Study Contacts

Valérie SARTORI

CONTACT

368767223v.sartori@icans.eu

Manon VOEGELIN, PhD

CONTACT

368767360promotion-rc@icans.eu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2020

First Posted

November 20, 2020

Study Start

December 15, 2021

Primary Completion (Estimated)

December 15, 2029

Study Completion (Estimated)

December 15, 2029

Last Updated

August 3, 2022

Record last verified: 2022-08

Locations

FR(1)