12. Towards the treatment of invasive breast cancer
To guide the use of chemotherapy in women with hormone receptor positive, HER2-negative, and lymph node negative or up to 3 lymph nodes positive invasive breast cancer, the ECIBC's Guidelines Development Group (GDG):
- recommends not using the 70 gene signature test when women are at low clinical risk (strong recommendation, low certainty of the evidence)
- suggests using the 70 gene signature test when women are at high clinical risk (conditional recommendation, low certainty of the evidence)
- suggests using the 21 gene recurrence score (conditional recommendation, very low certainty of the evidence)
Multigene testing: 70 gene signature at high clinical risk
Issued on: November 2018
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 |
| Low certainty of the evidence |
Justification
In the high clinical risk group, the recommendation is conditional in favour of using the 70 gene signature testing to guide the use of chemotherapy mainly because of the 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.
DefinitionHigh 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).
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 five years.
Supporting material
- Organised vs. non-organised screening
- Double vs. single reading in mammograpy screening
- Communication skills training
- Communication with care providers
- Optimal number of mammography readings
- Specialised training
- Risk stratification
- Women aged 40-44: screening vs. no screening
- Women aged 45-49: screening vs. no screening
- Women aged 45-49: annual vs. biennial screening
- Women aged 45-49: annual vs. triennial screening
- Women aged 45-49: triennial vs. biennial screening
- Women aged 50-69: screening vs. no screening
- Women aged 50-69: annual vs. biennial screening
- Women aged 50-69: annual vs. triennial screening
- Women aged 50-69: triennial vs. biennial screening
- Women aged 70-74: screening vs. no screening
- Women aged 70-74: annual vs. biennial screening
- Women aged 70-74: annual vs. triennial screening
- Women aged 70-74: triennial vs. biennial screening
- Single reading with AI support
- Double reading with AI support
- Screening with tomosynthesis vs. mammography
- Screening with tomosynthesis plus mammography vs. mammography alone
- Tailored screening with tomosynthesis
- Screening with tomosynthesis vs. mammography
- Tailored screening with MRI
- Tailored screening with ABUS
- Tailored screening with HHUS
- Informing about benefits and harms: use of decision aids
- Informing about benefits and harms: Numbers in addition to plain language
- Informing about benefits and harms: Infographics in addition to plain language
- Informing about benefits and harms: Story telling in addition to plain language
- Inviting women to screening: letter vs. no invitation
- Inviting socially disadvantaged women to screening: Targeted vs. general communication strategy
- Inviting women with an intellectual disability to screening
- Inviting non-native speakers to screening
- Inviting socially disadvantaged women to screening: Tailored vs. targeted communication strategy
- Inviting socially disadvantaged women to screening: Tailored vs. general communication strategy
- Inviting women to subsequent screening rounds: letter vs. no invitation
- Inviting women to screening: letter with fixed appointment vs. letter
- Inviting women to subsequent screening rounds: letter with fixed appointment vs. lett
- Inviting women to screening: letter with GP signature vs. letter
- Inviting women to subsequent screening rounds: letter with GP signature vs. letter
- Inviting women to screening: letter followed by phone call vs. letter
- Inviting women to subsequent screening rounds: letter followed by phone call vs. letter
- Inviting women to screening: letter followed by phone call vs. no invitation
- Inviting women to screening: letter followed by written reminder vs. letter
- Inviting women to subsequent screening rounds: letter followed by written reminder vs. letter
- Inviting women to screening: letter followed by face to face intervention vs. letter
- Inviting women to subsequent screening rounds: letter followed by face to face intervention vs. letter
- Inviting women to screening: e-mail vs. letter
- Inviting women to screening: automated telephone call vs. letter
- Inviting women to screening: letter followed by automated telephone call vs. letter
- Inviting women to screening: letter followed by SMS notification vs. letter
- Inviting women to screening: letter followed by personalised phone call vs. automated phone call
- Negative result: letter vs. nothing
- Further assessment: letter followed by a phone call
- Further assessment: timing of results
- Negative result: phone call vs. letter
- Negative result: face to face interview vs. letter
- Negative result: timing of results
- Tomosynthesis vs. assessment mammography
- Obtaining a sample from a suspicious breast lesion
- Type of guidance for needle core biopsy
- Stage 1: conventional exams
- Stage 1: PET-CT exams
- Stage 2: conventional exams
- Stage 2: PET-CT exams
- Stage 3: conventional exams
- Stage 3: PET-CT exams
- Stage 3: conventional exams plus PET-CT
- Use of clip-marking
- Additional magnetic resonance imaging
- Contrast-enhanced mammography
- Threshold of oestrogen for endocrine therapy
- Threshold of progesterone for endocrine therapy
- Multigene testing: 70 gene signature at low clinical risk
- Multigene testing: 70 gene signature at high clinical risk
- Multigene testing: 21 gene recurrence score
- Organising screening programmes
- Risk stratification
- Women 40-44
- Women 45-49
- Women 50-69
- Women 70-74
- Women with high breast density
- General Population
- Vulnerable Population
- Informing women about their results
- Women recalled due to suspicious lesions
- Obtaining a sample from a suspicious lesion
- Type of guidance for needle core biopsy
- Stage 1
- Stage 2
- Stage 3
- Planning surgical treatment
- Hormone receptor to guide use of endocrine therapy
- Multigene testing to guide use of chemotherapy