Probability of OncotypeDx to Reallocate As Low or High Risk of Recurrence Breast Cancer Patients with Uncertain Biology

NCT06363812 | Completed

• 1 other identifier: The POST
• Study Type: observational
• Target: 258
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

estrogen receptor positive; HER2 negative

Outcome Measures

Primary Outcomes (1)

• the proportion of tumor samples with a useful OncotypeDx

  number of low risk and high risk at OncotypeDx divided by the total number of tests

  15 days

Secondary Outcomes (2)

• the proportion of patients in which the result of the test has induced a modification in the initial treatment plan

  15 days

• the proportion of tumor samples with an intermediate risk or not evaluable at OncotypeDx

  15 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

primary care clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Sandro Pitigliani: lead
• Genomic Health®, Inc.: collaborator
• Istituto Toscano Tumori: collaborator

Study Sites (1)

Hospital of Prato

Prato, 59100, Italy

Location

Related Publications (7)

• Albain KS, Barlow WE, Shak S, Hortobagyi GN, Livingston RB, Yeh IT, Ravdin P, Bugarini R, Baehner FL, Davidson NE, Sledge GW, Winer EP, Hudis C, Ingle JN, Perez EA, Pritchard KI, Shepherd L, Gralow JR, Yoshizawa C, Allred DC, Osborne CK, Hayes DF; Breast Cancer Intergroup of North America. Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial. Lancet Oncol. 2010 Jan;11(1):55-65. doi: 10.1016/S1470-2045(09)70314-6. Epub 2009 Dec 10.

  PMID: 20005174 BACKGROUND

• Cheang MC, Chia SK, Voduc D, Gao D, Leung S, Snider J, Watson M, Davies S, Bernard PS, Parker JS, Perou CM, Ellis MJ, Nielsen TO. Ki67 index, HER2 status, and prognosis of patients with luminal B breast cancer. J Natl Cancer Inst. 2009 May 20;101(10):736-50. doi: 10.1093/jnci/djp082. Epub 2009 May 12.

  PMID: 19436038 BACKGROUND

• Dowsett M, Cuzick J, Wale C, Forbes J, Mallon EA, Salter J, Quinn E, Dunbier A, Baum M, Buzdar A, Howell A, Bugarini R, Baehner FL, Shak S. Prediction of risk of distant recurrence using the 21-gene recurrence score in node-negative and node-positive postmenopausal patients with breast cancer treated with anastrozole or tamoxifen: a TransATAC study. J Clin Oncol. 2010 Apr 10;28(11):1829-34. doi: 10.1200/JCO.2009.24.4798. Epub 2010 Mar 8.

  PMID: 20212256 BACKGROUND

• Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 May 14-20;365(9472):1687-717. doi: 10.1016/S0140-6736(05)66544-0.

  PMID: 15894097 BACKGROUND

• Harris LN, Ismaila N, McShane LM, Hayes DF. Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Summary. J Oncol Pract. 2016 Apr;12(4):384-9. doi: 10.1200/JOP.2016.010868. Epub 2016 Mar 8. No abstract available.

  PMID: 26957642 BACKGROUND

• Paik S, Tang G, Shak S, Kim C, Baker J, Kim W, Cronin M, Baehner FL, Watson D, Bryant J, Costantino JP, Geyer CE Jr, Wickerham DL, Wolmark N. Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol. 2006 Aug 10;24(23):3726-34. doi: 10.1200/JCO.2005.04.7985. Epub 2006 May 23.

  PMID: 16720680 BACKGROUND

• Perou CM, Sorlie T, Eisen MB, van de Rijn M, Jeffrey SS, Rees CA, Pollack JR, Ross DT, Johnsen H, Akslen LA, Fluge O, Pergamenschikov A, Williams C, Zhu SX, Lonning PE, Borresen-Dale AL, Brown PO, Botstein D. Molecular portraits of human breast tumours. Nature. 2000 Aug 17;406(6797):747-52. doi: 10.1038/35021093.

  PMID: 10963602 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Laura Biganzoli, MD

  Hospital of Prato

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: March 8, 2018
• Primary Completion: May 15, 2021
• Study Completion: December 31, 2024
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)