Identification of Genetic Determinants for Treatment Resistance/Sensitivity and/or Toxicity in Adjuvant Setting for HER2 Positive Breast Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorCentre Paul Strauss

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

HER2-positive Breast Cancer

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood sample for genetic analysis

    Other intervention

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

Treatment groups

9,000 Participants
are divided into 5 treatment groups
Group A: HER2 positive breast cancer treated only with trastuzumab1 intervention
Group B: HER2 positive breast cancer treated with pertuzumab1 intervention
Group C: HER2 positive breast cancer treated with neratinib1 intervention
Group D: HER2 positive breast cancer treated with Trastuzumab emtansine (TDM1)1 intervention
Group E: HER2 positive breast cancer treated with TDM1 and neratinib1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
at the end of enrollment (3 years)
2

Disease Free Survival (DFS)

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

Time frame
At the end of the study (8 years)
3

Overall Survival (OS)

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

Time frame
At the end of the study (8 years)

Secondary outcomes

Other outcomes

Sponsors and contacts

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