1408 - A prognostic RT-qPCR test run locally for ER+ve /HER2-ve breast cancer that determines the risk of early and late metastasis in node negative and positive cancer under endocrine treatment.

Page last updated: 25 October 2016

Application Detail

Status

Open

Description of Medical Service

In-vitro diagnostics product combining gene expression with classical prognostic factors including tumor size and nodal status. The test determines the early and late risk of reoccurrence and distant metastases in patients with ER+ve/HER2-ve primary breast cancer. The test generates a binary result with clear unambiguous prognosis to support treatment decision making for chemotherapy as well as extended anti-hormonal therapy. It can be performed in local pathology laboratories under Australian regulatory standards.
While many ER+/HER-ve patients require chemotherapy, the majority of these patients could be sufficiently treated with anti-hormonal therapy alone, which has fewer side effects. By understanding a patient’s prognosis and risk, this valuable information can be used to select appropriate therapy without jeopardizing the overall treatment success. Many patients can be spared unnecessary toxic chemotherapy and at times the associated debilitating side effects.

Description of Medical Condition

One of the most pressing clinical questions in the management of ER positive and HER2 negative breast cancer patients which is not satisfactorily addressed by current guidelines is whether to limit systemic treatment to just endocrine therapy or to employ adjuvant chemotherapy. Using current tools a large population of such patients fall within the intermediate category leading to substantial overtreatment. Additional tools added to classical parameters improve stratification of the ambiguous intermediate group into low and high risk categories to guide treatment decisions provide considerable clinical value.

Reason for Application

New MBS item

Medical Service Type

Investigative

Previous Application Number

Not Applicable

Associated Documentation

Application Form

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PICO Confirmation

Final Protocol (PDF 2940 KB)
Final Protocol (Word 245 KB)

Assessment Report

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Public Summary Document

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Meetings for this Application

PASC

13 August 2015

ESC

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MSAC

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