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Breast cancer genomic tests Paris
Logo Dr J. Zeitoun
Precision medicine · Paris 8th & Neuilly-sur-Seine

Genomic tests for breast cancer Dr Jérémie Zeitoun · Breast surgeon Paris

Oncotype DX, MammaPrint, EndoPredict, Prosigna: four tests that analyse the gene activity of your tumour to answer a single question — is chemotherapy really necessary in your case?

Dr Jérémie Zeitoun surgeon Paris
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Key points

Key figures

~30%
of breast cancers are potentially eligible for a genomic test
4 tests
validated and reimbursed by the French HAS (2023)
60-70%
of eligible patients avoid chemotherapy thanks to the test
21 to 70
genes analysed depending on the test (12 for EndoPredict, 21 for Oncotype, 50 for Prosigna, 70 for MammaPrint)
7-14 d
usual turnaround time for the result
10,273
patients in the TAILORx trial (Oncotype DX)
6,693
patients in the MINDACT trial (MammaPrint)
100%
covered by the French national health insurance
0
extra biopsy: the analysis uses the tumour already collected
MDT
the final decision lies with the multidisciplinary team meeting
Genomic test unclear?
Speak with Dr Zeitoun
Quick consultation in Paris 8th or Neuilly. Second opinions welcome.
Understand

What is a breast cancer genomic test?

A breast cancer genomic test analyses the activity of certain genes within your tumour. It does not look at your own DNA: it looks at the DNA of the cancer cells, and only at a few dozen genes selected because they are linked to recurrence risk.

Here is the idea: not all breast cancers are alike, even when they share the same size and grade under the microscope. For some tumours, hormone therapy alone is sufficient to prevent recurrence. For others, adding chemotherapy provides a real survival benefit. These two profiles are sometimes indistinguishable on standard pathology — that is exactly where genomic tests come in.

Diagram: breast cancer genomic test, analysis of tumour gene activity

The genomic test analyses tumour gene activity to predict its behaviour.

The genomic test brings the missing piece of information. It gives a numerical score that essentially says: "this is how likely your tumour is to come back if we only give hormone therapy". If the score is low, chemotherapy will bring little to nothing, and it can be skipped. If the score is high, it will bring real benefit and should be given.

Important — not to be confused: this test has nothing to do with the oncogenetics consultation. Oncogenetics looks for an inherited constitutional mutation (BRCA1, BRCA2, PALB2…) on a blood sample: it evaluates your and your family's risk of developing other cancers. The genomic test, on the other hand, is performed on the tumour itself and says nothing about heredity — it only predicts how this specific cancer will behave. Both can be offered in parallel, but they answer completely different questions.

The 4 tests

The four tests recognised in France

The French health authority (HAS) approved four tests in 2023. They all answer the same question (should chemotherapy be given?) but with different methods. The choice between them depends on the laboratory, the team and the patient profile — they are broadly equivalent for the final decision.

Oncotype DX

21 genes analysed. This is the most widely used test in France and worldwide, validated by the TAILORx trial (10,273 patients) and recommended first-line by the French health authority (HAS). The result is a score called Recurrence Score (RS), ranging from 0 to 100.

  • Score < 11: chemo brings no benefit — hormone therapy alone
  • Score 11-25: no benefit if N0 postmenopausal — hormone therapy alone
  • Score > 25: clear chemotherapy benefit

Evidence level: IA (the highest) per HAS.

MammaPrint

70 genes analysed. Dutch-developed test, validated by the MINDACT trial (6,693 patients). Rather than a numerical score, the result is binary: the tumour is classified as low risk or high risk of recurrence.

  • Low risk: chemo brings no significant benefit — hormone therapy alone
  • High risk: chemo is recommended in addition to hormone therapy

Evidence level: IA per HAS.

EndoPredict

12 genes analysed. European-developed test. Its specificity: it combines gene analysis with clinical information (tumour size, number of involved nodes) to provide a combined score called EPclin.

  • Low score: hormone therapy alone
  • High score: chemo + hormone therapy
  • Strength: recurrence prediction up to 10-15 years

Evidence level: IB per HAS.

Prosigna (PAM50)

50 genes analysed (PAM50 signature). This test does two things: it gives a risk score (the ROR, Risk Of Recurrence) and precisely identifies the biological subtype of the cancer (luminal A or luminal B).

  • Low ROR + luminal A: hormone therapy alone
  • High ROR or luminal B: chemo + hormone therapy
  • Specificity: precise biological characterisation

Evidence level: IB per HAS.

Indications

Who is the test for?

The genomic test is not indicated for all breast cancers. It applies to a precise profile defined by the HAS 2023 guidelines.

✓ Who the test is useful for

  • Hormone-dependent breast cancer: ER+ and/or PR+
  • HER2-negative cancer (HER2−)
  • 0 involved nodes (N0) or 1 to 3 nodes involved (N1)
  • Preferably postmenopausal patient (the test is less useful in young women with node-positive disease)
  • When the team is unsure whether to give chemotherapy or not

✗ Who the test is NOT for

  • Triple-negative cancer (ER−, PR−, HER2−): chemo is necessary anyway
  • HER2-positive cancer: clear indication for targeted therapy + chemo
  • Cancer with ≥4 involved nodes: chemo necessary
  • Premenopausal women with positive nodes: recent trials (RxPonder) show benefit from chemo even with a low score
  • Metastatic cancer

The decision to prescribe a genomic test belongs to the multidisciplinary team meeting (MDT), gathering surgeon, oncologist, pathologist and radiation oncologist. The test is then performed on the tumour material already available (biopsy or surgical specimen): no new sample is needed.

Pathway

How does the test unfold?

From diagnosis to the final decision, here are the typical steps.

  1. 1

    Diagnosis and biopsy

    The cancer is confirmed by biopsy, and the pathology assessment provides the first information: hormone receptors, HER2, Ki67, grade.

  2. 2

    MDT discussion: genomic test indicated?

    All the doctors involved in your care (surgeon, oncologist, radiation oncologist, pathologist) meet to discuss your case. If your cancer is hormone-positive, with no significant lymph node involvement, and chemotherapy is not clear-cut, they order a genomic test to help decide.

  3. 3

    Laboratory analysis

    The tumour block (already collected during the biopsy or surgery) is sent to the laboratory that performs the test. No new sample from the patient. Result within 7 to 14 days.

  4. 4

    New MDT with the result

    The team meets again with the test score in hand. The decision is made: hormone therapy alone (if low score) or chemo + hormone therapy (if high score).

  5. 5

    Disclosure and shared decision

    The result is explained to the patient, with arguments for and against chemo. The final choice always emerges from dialogue with the medical team.

  6. 6

    Tailored treatment

    Depending on the score: surgery ± chemotherapy, radiotherapy, hormone therapy for 5 to 10 years.

  7. 7

    Close follow-up

    Annual clinical and radiological surveillance for at least 10 years, with monitoring of hormone therapy tolerance.

Need help interpreting your test?
Get a second opinion
Dr Zeitoun reviews your case and clarifies your score.
EXPLORE

Related reading

The essential pages to better understand your pathway.

Pillar page
Breast cancer
Diagnosis, treatments, full pathway
Treatment
Chemotherapy
When the test indicates it is needed
Understand
Pathology report
Read your report: ER, PR, HER2, Ki67, grade
Surgery
Lumpectomy
Breast-conserving surgery
Surgery
Mastectomy
When breast-conserving surgery is not possible
Associated procedure
Sentinel lymph node
Axillary assessment and its consequences
CONSULTATION

Second opinion

Before accepting or declining chemotherapy, you have the right — and it is even recommended — to ask for a second opinion. If the genomic test was not offered while your profile suggested it, or if you wish to clarify the interpretation of the result, Dr Zeitoun regularly sees patients in consultation for these questions.

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Comparison of the 4 tests

TestGenesResultMajor trialHAS level
Oncotype DX21Continuous score 0-100 (Recurrence Score)TAILORx (n=10,273)IA
MammaPrint70Binary: low risk / high riskMINDACT (n=6,693)IA
EndoPredict12Combined EPclin score (genes + clinical features)Filipits 2011, TransATACIB
Prosigna (PAM50)50ROR score + subtype (luminal A/B)Wallden 2015, ABCSG-8IB

Level IA: strongest evidence (prospective randomised trials specifically designed to validate the clinical utility of the test). Level IB: solid evidence from retrospective cohorts or secondary analyses.

Bibliography

References used for this page, in line with the French HAS 2023 guidelines, SénoriF 2025-2026 and reference international trials.

  1. Sparano JA, Gray RJ, Makower DF, et al. Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer (TAILORx). N Engl J Med 2018;379:111-121. PubMed 29860917
  2. Cardoso F, van't Veer LJ, Bogaerts J, et al. 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer (MINDACT). N Engl J Med 2016;375:717-729. PubMed 27557300
  3. Kalinsky K, Barlow WE, Gralow JR, et al. 21-Gene Assay to Inform Chemotherapy Benefit in Node-Positive Breast Cancer (RxPonder). N Engl J Med 2021;385:2336-2347. PubMed 34914339
  4. Filipits M, Rudas M, Jakesz R, et al. A new molecular predictor of distant recurrence in ER-positive, HER2-negative breast cancer (EndoPredict). Clin Cancer Res 2011;17:6012-20. PubMed 21807638
  5. Wallden B, Storhoff J, Nielsen T, et al. Development and verification of the PAM50-based Prosigna breast cancer gene signature assay. BMC Med Genomics 2015;8:54. PubMed 26297356
  6. Cardoso F, van't Veer LJ, Poncet C, et al. MINDACT: Long-term results of the large prospective trial testing the 70-gene signature. Lancet Oncol 2021;22:476-488. PubMed 33721561
  7. Sparano JA, Gray RJ, Ravdin PM, et al. Clinical and Genomic Risk to Guide the Use of Adjuvant Therapy for Breast Cancer. N Engl J Med 2019;380:2395-2405. PubMed 31157962
  8. Andre F, Ismaila N, Allison KH, et al. Biomarkers for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer: ASCO Guideline Update. J Clin Oncol 2022;40:1816-1837. PubMed 35439025
  9. Sestak I, Buus R, Cuzick J, et al. Comparison of the Performance of 6 Prognostic Signatures for oestrogen Receptor-Positive Breast Cancer. JAMA Oncol 2018;4:545-553. PubMed 29450494
  10. Buus R, Sestak I, Kronenwett R, et al. Comparison of EndoPredict and EPclin With Oncotype DX Recurrence Score. J Natl Cancer Inst 2016;108:djw149. PubMed 27400969
  11. HAS. Clinical utility of genomic signatures in early-stage breast cancer. Guidelines 2023. has-sante.fr
  12. SénoriF. Île-de-France breast oncology guidelines 2025-2026. senorif.com

Frequent questions

What is a breast cancer genomic test?

It is an analysis of the activity of certain genes within the tumour itself (on the surgical specimen or biopsy). The test measures how aggressive the cancer is and calculates a score that helps decide whether chemotherapy is useful in addition to hormone therapy.

How does it differ from an oncogenetics consultation?

Two very different tests. Oncogenetics looks for an inherited mutation (BRCA1, BRCA2, PALB2…) from a blood sample: it assesses family risk. The genomic test is performed on the tumour only: it says nothing about heredity, just about how this particular cancer will behave.

Is the test reimbursed?

Yes. Since the French HAS 2023 ruling, all four genomic tests (Oncotype DX, MammaPrint, EndoPredict, Prosigna) are covered by the French national health insurance in their validated indications. No out-of-pocket cost for the patient.

How long does the result take?

Between 7 and 14 days as a rule. The tumour (from the biopsy or surgical specimen) is sent to the laboratory that performs the analysis, then the result is returned to your referring doctor. No new biopsy is needed.

Which test to choose between the four?

All four tests are validated. Oncotype DX and MammaPrint have the highest evidence level (IA). The choice often depends on the available laboratory and the team's habit. Whatever the test, the final MDT decision is reliable.

If my score is high, must I have chemo?

A high score indicates that chemo brings a clear benefit on recurrence risk. The final decision remains shared between the patient and the team, taking into account age, comorbidities and personal preferences, but chemo is generally recommended.

Why didn't my doctor offer me the test?

Several possible reasons: your cancer profile does not match the indications (triple-negative, HER2+, ≥4 nodes), the decision is already clear-cut (obvious chemo or no chemo), or the test is not yet systematic in all teams. If you have any doubt, a second opinion is legitimate.

FREN