MINDACT Trial Results(Microarray In Node negative and 1-3 positive lymph node Disease
may Avoid Chemotherapy)
MINDACT is the first and only Phase III prospective, randomized controlled clinical trial comparing
a genomic breast cancer recurrence assay to clinicopathological risk assessment (standard of care).

Baseline characteristics of the MINDACT study population
LOW RISKOVERTREATMENT
GROUP(no chemo)*

C=

MP=

C=

UNDERTREATMENT
GROUP

C=

MP=

MP=

HIGH RISK(chemo)†C=

MP=n = 2,745 (41%)

CPFs HIGH
MammaPrint LOWn = 1,550 (23%)

CPFs LOW
MammaPrint HIGHn = 592 (9%)

n= 1,806 (27%)

96% Luminal

91% Luminal

79% Luminal• HER2+ : 12%• Triple Neg : 9%

50% Luminal• HER2+ :19%
• Triple Neg : 31%

Grade

Grade 1 or 2
98%

Grade 2 or 3
93%

Grade 1 or 2
85%

Grade 376%

Node Positive

6%

48%

2%

26%

Tumor Size>2cm4%

58%

2%

48%

IHC
Subtype• HER2+ : 4%

• HER2+ : 8%
• Triple Neg : 1%

5-year DMFS

97.6%

94.7%

93.9%

90.6%

Distant Metastasis Free Survival(96.9 - 98.1) - no ACT(92.5 - 96.2) - no ACT(89.6 - 96.5) - no ACT(89.0 - 92.0) - CT

Primary Analysis
Population

Data from the Primary Analysis: 5-year DMFS for patients with high risk clinical features
identified as Low Risk by MammaPrint, without chemotherapy
Distant Metastasis Free Survival without Chemo

C=MP=CPFs High / MammaPrint Low

100
90no CT

80

48%

60

of patients in this groupwere lymph node positive.

58%

of patients in this group hada tumor size greater than2cm.

93%

of patients in this group hadtumors that were grade IIor III.

DMFS=94.7%
at 5 years

70

Distant Metastasis Free Survival (DMFS)

50
40
30PT population(primary test)

20Patients(N)

ObservedEvents(O)

644

38

% at 5 Years(95% CI)
94.7(92.5, 96.2)

100(years)
01O

N

38

644

2

Number of patients
625
608

3

4

5598

567

374

PT

O: Observed events
N: Number of patientsMINDACT Trial Results(Microarray In Node negative and 1-3 positive lymph node Disease
may Avoid Chemotherapy)

Efficacy of chemotherapy was determined by comparing DMFS at 5 years(All patients cHigh / MP Low)
Distant Metastasis Free Survival

10090OVERTREATMENT GROUP

C=MP=

CPFs HIGH
MammaPrint LOW

807060504030

AllocatedTreatment
Strategy% at 5 Year(s)(95% CI)

Hazard Ratio(adjusted Cox model)(95% CI)CT

95.9 (94.0, 97.2)

0,78 (0,50-1,21)

no CT

94.4 (92.3,95.9)

1.00

p-value
0,267

20
100(years)
0O
34
46

1
N749
748

2345

Number of patients
714
698
727
708

677
696

611
655

346
424

Allocated to:CTno CT• MINDACT data shows that in the presence of high risk

clinicopathologic features, there is no significant or
clinically meaningful benefit to adding chemotherapy for
MammaPrint Low Risk patients.

MINDACT Results Summary
MammaPrint was developed independent of clinicopathologic factors so it’s the only assay that provides added value
to the treatment decision and can be used in conjunction with clinical factors.
MINDACT demonstrates that MammaPrint is the only breast cancer genomic assay that selectively identifies earlystage breast cancer patients with high risk features (Lymph node positivity (LN 1-3), grade II or III, size >2cm) as
Low Risk with no clinically meaningful benefit of chemotherapy.
MINDACT proves that MammaPrint is superior as a standalone test to the current standard of care in predicting thebenefit of chemotherapy for early-stage breast cancer patients, minimizing the risk of undertreatment.

“MINDACT provides indisputable Level 1A, phase III, randomized
prospective clinical evidence that proves the superiority ofMammaPrint 70-Gene Assay in predicting the benefit ofchemotherapy in early-stage breast cancer patients when compared
to clinicopathological risk assessment.

References1.
Cardoso, F. et al. “70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer.” N Engl J Med. 2016;375:717-29 (including Supplemental data)

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