Clinical trial NCT06363812: Probability of OncotypeDx to Reallocate As Low or High Risk of Recurrence Breast Cancer Patients with Uncertain Biology
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: estrogen receptor positive
HER2 negative
Lead sponsor: Fondazione Sandro Pitigliani
Sponsor class: OTHER
Collaborators: name: Genomic Health®, Inc.
name: Istituto Toscano Tumori
First posted: 2024-04-12
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: the proportion of tumor samples with a useful OncotypeDx
timeFrame: 15 days
Secondary outcomes:
measure: the proportion of patients in which the result of the test has induced a modification in the initial treatment plan
timeFrame: 15 days
measure: the proportion of tumor samples with an intermediate risk or not evaluable at OncotypeDx
timeFrame: 15 days
Other outcomes:
Locations:
city: Prato
country: Italy
facility: Hospital of Prato
Study officials:
affiliation: Hospital of Prato
name: Laura Biganzoli, MD
role: PRINCIPAL_INVESTIGATOR
References:
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