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ER-positive Her2-negative Early Breast CancerOPTIGENNCT03080428

Assessment of Genomic Test Impact on Shared Decision of Adjuvant Chemotherapy in ER-positive, Her2-negative Early Breast Cancer

A study testing Genomic test in people with ER-positive Her2-negative Early Breast Cancer, run by UNICANCER.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The need/benefit of adjuvant chemotherapy could be negligible for a certain category of patient with newly diagnosed unilateral non metastatic breast cancer. Physicians are sometimes divided between the administration of adjuvant treatment and no administration when the risk of distant relapse at 10 years is around… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Genomic test
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
May 2017to May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Woman, Age ≥ 18 years;
  • Performance status 0 or 1 (according to World Health Organization criteria);
  • Patient with newly diagnosed, unilateral, localized, histologically confirmed, invasive breast cancer; Note: Multicentric/multifocal tumors are allowed provided a maximum of 3 lesions are present, and all are ER > 10% or Allred ≥ 4, Her2-negative (genomic test will be performed on the lesion considered the most pertinent by the multidisciplinary team)
  • Fully operated breast cancer including complete resection of breast tumor and adequate axillary surgery;
  • Available surgical material (formalin-fixed, paraffin-embedded) for genomic test evaluation;
  • ER-positive by immuno-histochemical (>10% cells stained or Allred Score≥4);
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  • HER2-negative by IHC (score 0 or 1+) and/or fluorescence in situ hybridization/silver in situ hybridization/chemiluminescent in situ hybridization ;
  • Uncertainty regarding the toxicity/benefit of adjuvant chemotherapy, outlined in the following situations:
  • Grade 1: pT3 or 1-3 node positive
  • Grade 2: pT1 pN0 but high proliferation (Ki67 >20%) or lympho-vascular emboli, or 1-3 node positive
  • Grade 2 : pT2 pN0
  • Grade 3: pT1 pN0
  • 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.

Who cannot join

  • Non operable, bilateral, locally advanced, T4 or metastatic breast cancer;
  • HER2 Overexpression, as assessed by 3+ IHC or FISH/SISH/CISH amplification;
  • 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.

About this study

Official title: Prospective Multicenter Randomized Study Assessing 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.

The need/benefit of adjuvant chemotherapy could be negligible for a certain category of patient with newly diagnosed unilateral non metastatic breast cancer. Physicians are sometimes divided between the administration of adjuvant treatment and no administration when the risk of distant relapse at 10 years is around 10% with uncertainty and a theoretical benefit of chemotherapy is less than 5% at 10 years according to guidelines in use in the center.

Several genomic tests have been developed this last decade. These tests use a sample of breast cancer tissue to analyze the activity of a group of genes. Knowing whether certain genes are present or absent, overly active or not active enough, can help physicians predict the risk of recurrence.

Read more

In addition to standard pathological characteristics, a genomic test could be helpful in making treatment decisions, such as whether or not chemotherapy should be part of the treatment plan. First generation prognostic tests are currently widely used worldwide to guide decision making regarding adjuvant chemotherapy (OncotypeDX™ Mammaprint®). Prognostic tests have reached a level of evidence 1A, with the results of the prospective randomized trial "Mindact". In the "Mindact" trial, among women with early-stage breast cancer who were at high clinical risk and low genomic risk for recurrence, the receipt of no chemotherapy on the basis of the 70-gene signature led to a 5-year rate of survival without distant metastasis that was 1.5 percentage points lower than the rate with chemotherapy. Given these findings, approximately 46% of women with breast cancer who are at high clinical risk might not require chemotherapy. The health-economic value of such signatures in the general population of patients with localized breast cancer appears very low at current costs.

Meanwhile, next generation prognostic signatures have been developed that have integrated clinical parameters and suggest high added value beyond all standard and traditional characteristics including tumor burden, grade, Estrogen Receptor (ER) and Progesterone Receptor (PR), Her2, age and also standard assessment of proliferation.

In this study, the clinical utility of genomic tests (Endopredict®, Prosigna®, OncotypeDX®, Mammaprint® assay) defined as impact on chemotherapy decision in the adjuvant setting in patients with ER-positive, Her2-negative early breast cancer with uncertainty on the indication of chemotherapy using standard assessments will be compared.

Being tested
Genomic test
Keywords
Breast cancer, ER-positive, Her-2 negative, genomic test
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Genomic testDiagnostic test

    genomic test realized on surgery block or formalin-fixed paraffin-embedded slides

Study groups in NCT03080428
Study groupRoleWhat they receive
Endopredict®Active comparatorgenomic test Endopredict® realized on surgery tumour samples
Receives: Diagnostic Test: Genomic test
Prosigna®Active comparatorgenomic test Prosigna® realized on surgery tumour samples
Receives: Diagnostic Test: Genomic test
OncotypeDX®Active comparatorgenomic test OncotypeDX® realized on surgery tumour samples
Receives: Diagnostic Test: Genomic test
Mammaprint® assayActive comparatorgenomic test Mammaprint® assay realized on surgery tumour samples
Receives: Diagnostic Test: Genomic test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of genomic tests clinical utility

    Pairwise comparisons between genomic tests in terms of percentage of changes between initial adjuvant chemotherapy decision and final receipt of chemotherapy (yes/no)

    Measured: At the end of the inclusion period: 12 months

Secondary outcomes (7)

  1. Distant disease-free survival in patients who do not receive chemotherapy

    5-year distant disease-free survival among the pooled cohort of patients who did not receive chemotherapy

    Measured: 5 years

  2. Distant disease-free survival in patients who do not receive chemotherapy based on genomic test result.

    5-year distant disease-free survival in patients who did not receive chemotherapy based on genomic test result

    Measured: 5 years

  3. Reason for discordant final decision when they occur

    Number of decision changes according to the test results. Physicians' and patients' reasons for "non-compliance" with the test's results will be recorded (a threshold at 10% 10 year distant recurrence risk will be chosen)

    Measured: 12 months

  4. Feasibility of test in terms of time interval.

    Time interval between prescription and result of the test (% < 10 days)

    Measured: 12 months

  5. differences in results between local and central reading of ER, PR, Her2 and Ki67

    A comparison with local evaluation of HR, Her2, and ki-67 will be made

    Measured: 12 months

  6. Change of therapy based on the genomic test findings in a virtual tumour board

    Choice of therapy in a virtual tumour board based on the genomic test findings

    Measured: 12 months

  7. Evaluation of the cost effectiveness of genomic tests

    Medico-economic impact based on results of the "Optisoin 01" study

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2017
  2. Study startMay 2017 (estimated)
  3. Primary completionJun 2018 (estimated)
  4. Study completionMay 2023 (estimated)

Why it stopped: The study has been withdrawn because of lack of funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be identified prior to surgery based on biopsy results. During the post-operative multidisciplinary decision-making meeting, a first therapeutic decision to prescribe or not an adjuvant chemotherapy will be taken according to usual clinical and histopathological markers and official guidelines in use in the center. After the patient has signed the inform consent form, the surgical sample will be sent by the investigator site to a selected genomic platform according to the randomization result.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03080428
Sponsor's protocol ID
UC-0140/1620
Other IDs
2016-A01731-50, UCBG 2-15
Acronym
OPTIGEN
Status last verified
Aug 2017
First submitted
9 Mar 2017
Last updated
28 Aug 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Genomic test in people with ER-positive Her2-negative Early Breast Cancer, run by UNICANCER.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of genomic tests clinical utility (time frame: At the end of the inclusion period: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03080428.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2017.

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