In the last 15 years different multigene tests have been developed to stratify patients with early breast cancer in different risk groups by analysing the activity of various genes.

Healthcare question

Should 70 gene signature test vs. no testing be used for patients who have hormone receptor positive, HER2-negative, lymph node negative or up to 3 lymph nodes positive invasive breast cancer to guide the use of chemotherapy (subgroup: high clinical risk)

Recommendation

For women with hormone receptor positive, HER2-negative, lymph node negative or up to 3 lymph nodes positive invasive breast cancer at high clinical risk, the ECIBC's Guidelines Development Group (GDG) suggests using the 70 gene signature test to guide the use of chemotherapy.

Recommendation strength ­

  Conditional recommendation for the intervention

 Low certainty of the evidence

Subgroup considerations

The proportion of women with 2 or 3 node positive breast cancer were small, so the results may be less clear in this subgroup.

Considerations for implementation and policy making

Decreasing cost for the test would support widespread use - price negotiations may be appropriate.

Research priorities

Longer follow up studies would be needed, as currently there is only a follow-up of 5 years. 

Definition

High clinical risk refers to those patients with HR-positive and HER2-negative invasive breast cancer with either:

  • G1 and node negative and tumour size 3.1-5 cm
  • G1 and 1-3 positive nodes and tumour size 2.1-5 cm
  • G2 and node negative and tumour size 2.1-5 cm
  • G2 and 1-3 positive nodes and any tumour size
  • G3 and node negative and tumour size 2.1-5 cm
  • G3 and 1-3 positive nodes and any tumour size.

According to Adjuvant! Online (version 8.0 with HER2 Status) described in detail in the MINDACT trial (Cardoso F., van't Veer L.J., Bogaerts J., Slaets L., Viale G., Delaloge S.et al., 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer, 2016).

Supporting documents