Probability of OncotypeDx to Reallocate as Low or High Risk of Recurrence Breast Cancer Patients With Uncertain Biology

April 12, 2024 updated by: Fondazione Sandro Pitigliani

Prospective Study Evaluating the Probability of OncotypeDx to Allocate at Low or High Risk of Recurrence Early ER Positive HER2 Negative Breast Cancer Patients With Uncertain Biological Behavior Evaluated by Pathological Parameters

In some cases of hormone receptor positive, human epidermal growth factor receptor 2 (HER2) negative early breast cancer the benefit of adding adjuvant chemotherapy to hormonal treatment, estimated on the basis of the classical clinico-pathological parameters, is unclear. In these cases the application of a genomic test could be useful in guiding the therapeutic choice.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Oncotype Dx (ODx) is a 21-gene assay that classifies primary ER+ breast tumors into three categories of recurrence risk: High (HR), Intermediate (IR) and Low (LR).

Available data show that

  1. patients with ODx low score breast cancer perform well without chemotherapy,
  2. chemotherapy has an additive value to endocrine therapy in patients with ODx high score tumors, and
  3. the role of chemotherapy is unknown in patients with ODx intermediate score cancer.

In this study, the investigators aim to evaluate the capability of ODx to help in guiding the choice of systemic adjuvant treatment in a group of patients with ER+ and HER2- , node negative (pN0) or micrometastatic (pNmi) breast cancer with uncertain biological behavior for whom there is uncertainty about the indication of adjuvant chemotherapy.

Study Type

Observational

Enrollment (Actual)

258

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Prato, Italy, 59100
        • Hospital of Prato

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

primary care clinic

Description

Inclusion Criteria:

  • Histological diagnosis of infiltrating ductal or lobular ER+ HER2- early breast cancer adequately treated with surgery
  • Nodal status: no regional lymph node metastasis (pN0) or micrometastatic regional lymph node (pN1mic)
  • Uncertain biological behavior defined by all of the following parameters: ER >20% and progesterone receptor (PgR) >20% and Ki67 between 14% and 30% and G2
  • Written informed consent

Exclusion Criteria:

  • pathologic tumor stage (pT) > 5 cm (not applicable to the internal control group)
  • Prior neoadjuvant therapy
  • Evidence of metastatic disease
  • No axillary exploration (sentinel lymph node biopsy or axillary dissection)
  • Multifocal or multicentral or bilateral tumors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the proportion of tumor samples with a useful OncotypeDx
Time Frame: 15 days
number of low risk and high risk at OncotypeDx divided by the total number of tests
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the proportion of tumor samples with an intermediate risk or not evaluable at OncotypeDx
Time Frame: 15 days
number of intermediate risk and not evaluable at OncotypeDx divided by the total number of tests
15 days
the proportion of patients in which the result of the test has induced a modification in the initial treatment plan
Time Frame: 15 days
number of cases with a therapeutic change divided by the total number of tested cases
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Sandro Pitigliani

Collaborators

Genomic Health®, Inc.
Istituto Toscano Tumori

Investigators

  • Principal Investigator: Laura Biganzoli, MD, Hospital of Prato

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2018

Primary Completion (Actual)

May 15, 2021

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 9, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The POST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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