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Prospective Study Assessing EndoPredict® Genomic Test Impact on Shared Decision of Adjuvant Chemotherapy in Patients With ER-positive, Her2-negative Early Breast Cancer (ADENDOM)

Primary Purpose

Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

EPClin genomic test

About this trial

This is an interventional other trial for Breast Cancer focused on measuring Genomic test, Chemotherapy decision

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years,
Performance status 0 or 1,
Patient with newly diagnosed, previously untreated, unilateral, localized, histologically confirmed, invasive breast cancer
Fully operated breast cancer including complete resection of breast tumor and adequate axillary surgery
Available surgical material (formalin-fixed, paraffin-embedded) for EPclin® evaluation
ER-positive by IHC (>10% cells stained or Allred Score≥4)
HER2-negative by IHC (score 0 or 1+) and/or Fish/Cish
Node-negative or pN1mi (through axillary lymph node examination using sentinel node biopsy or axillary clearance)
Uncertainty regarding the toxicity/benefit of adjuvant chemotherapy, outlined inthe following situations:
- Lobular histology
- Or grade II
- Or grade III and pT < 2cm
Adequate renal, hepatic, cardiac and hematopoietic functions for a chemotherapy administration
Willingness and ability to comply with scheduled visits as well as with test results and chemotherapy decision according to the latest
Signed informed consent and Health insurance coverage

Exclusion Criteria:

Non operable, bilateral, locally advanced, T4 or metastatic breast cancer
Any lymph node involvement with the exception of pN0i+ or pN1mi
HER2 Overexpression
Diagnosis of any previous malignancy within the last 5 years, except for adequately treated basal cell carcinoma, or squamous cell skin carcinoma, or in situ cervical carcinoma
Any previous systemic or locoregional treatment for the present breast cancer
Documented inherited predisposition with BRCA1/2 or TP53 mutation
Previous hormone replacement therapy (HRT) stopped less than 2 weeks before surgery
Previous treatment for the present breast cancer
Person unable to give informed consent

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

EndoPredict (EP)clin testing

Arm Description

Once the patient is registered, the most representative block of the primary tumor from surgery (or 10 paraffin slides) are sent to the central analysis platform for EP clin testing. The EPclin method is based on analysis of tumour genes in combination with the classical prognostic factors of nodal status and tumour size.

Outcomes

Primary Outcome Measures

The proportion of patients whose choice of treatment is changed as a result of receiving the EPclin genomic test result

Secondary Outcome Measures

Impact of genomic test results on patient's quality of life (QoL), anxiety levels and satisfaction results using standardized "State-Trait-Anxiety Inventory" questionnaires compared with general condition at baseline.

Time required by the centralized platform to perform the test (calculated from the biological sample receipt to the genomic test results).

Full Information

NCT ID

NCT02773004

First Posted

April 27, 2016

Last Updated

August 31, 2023

Sponsor

UNICANCER

Collaborators

Myriad Genetics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02773004

Brief Title

Prospective Study Assessing EndoPredict® Genomic Test Impact on Shared Decision of Adjuvant Chemotherapy in Patients With ER-positive, Her2-negative Early Breast Cancer

Acronym

ADENDOM

Official Title

Prospective Multicenter Study Assessing EndoPredict® (EP) Genomic Test Impact on Shared Decision of Adjuvant Chemotherapy in Patients With ER-positive, Her2-negative Early Breast Cancer With Uncertainty on the Indication of Chemotherapy Using Standard Assessments

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

September 2016 (Actual)

Primary Completion Date

September 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UNICANCER

Collaborators

Myriad Genetics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The trial population of this study is composed of women aged more than 18, who have developed a newly node-negative (or pN1mi), Estrogen Receptor (ER)-positive, Her2-negative invasive breast cancer with uncertainty on the indication of adjuvant chemotherapy using standard assessments. Obtaining material for test is at no risk as done from the surgery material. Tumor molecular EndoPredict (EP)clin analysis will allow to obtain information on the expression of 8 breast cancer related genes and will provide important prognosis indications. Clinical validation studies have demonstrated that molecular assays are useful for stratifying patients into risk categories and helpful in making clinical treatment decisions in ER+/node-negative breast cancer patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Genomic test, Chemotherapy decision

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

203 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EndoPredict (EP)clin testing

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

EPClin genomic test

Primary Outcome Measure Information:

Title

The proportion of patients whose choice of treatment is changed as a result of receiving the EPclin genomic test result

Time Frame

15 days

Secondary Outcome Measure Information:

Title

Time Frame

1 year

Title

Time required by the centralized platform to perform the test (calculated from the biological sample receipt to the genomic test results).

Time Frame

1 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years, Performance status 0 or 1, Patient with newly diagnosed, previously untreated, unilateral, localized, histologically confirmed, invasive breast cancer Fully operated breast cancer including complete resection of breast tumor and adequate axillary surgery Available surgical material (formalin-fixed, paraffin-embedded) for EPclin® evaluation ER-positive by IHC (>10% cells stained or Allred Score≥4) HER2-negative by IHC (score 0 or 1+) and/or Fish/Cish Node-negative or pN1mi (through axillary lymph node examination using sentinel node biopsy or axillary clearance) Uncertainty regarding the toxicity/benefit of adjuvant chemotherapy, outlined inthe following situations: Lobular histology Or grade II Or grade III and pT < 2cm Adequate renal, hepatic, cardiac and hematopoietic functions for a chemotherapy administration Willingness and ability to comply with scheduled visits as well as with test results and chemotherapy decision according to the latest Signed informed consent and Health insurance coverage Exclusion Criteria: Non operable, bilateral, locally advanced, T4 or metastatic breast cancer Any lymph node involvement with the exception of pN0i+ or pN1mi HER2 Overexpression Diagnosis of any previous malignancy within the last 5 years, except for adequately treated basal cell carcinoma, or squamous cell skin carcinoma, or in situ cervical carcinoma Any previous systemic or locoregional treatment for the present breast cancer Documented inherited predisposition with BRCA1/2 or TP53 mutation Previous hormone replacement therapy (HRT) stopped less than 2 weeks before surgery Previous treatment for the present breast cancer Person unable to give informed consent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frédérique Penault-Llorca, MD, PhD

Organizational Affiliation

Centre Jean Perrin, Clermont Ferrand, France

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Suzette Delaloge, MD

Organizational Affiliation

Gustave Roussy, Villejuif, France

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

IPD Sharing Time Frame

Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.

IPD Sharing Access Criteria

The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.

Learn more about this trial

Prospective Study Assessing EndoPredict® Genomic Test Impact on Shared Decision of Adjuvant Chemotherapy in Patients With ER-positive, Her2-negative Early Breast Cancer

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