MammaPrint 70-Gene Breast Cancer Recurrence Test
Not Every Patient Diagnosed with Early-Stage Breast Cancer Needs Chemotherapy
MammaPrint and BluePrint genomic tests provide physicians with clear results to help prevent unnecessary chemotherapy in breast cancer treatment decisions. The MammaPrint test shows that not every patient diagnosed with early-stage breast cancer needs chemotherapy, which may cause serious side effects.
Women diagnosed with breast cancer at an early stage and whose breast tumor is smaller than 5 cm may, as part of standard practice, receive chemotherapy and/or other treatments after surgery depending on the patient’s clinical condition. The purpose of this approach is to reduce the risk of cancer recurrence and metastasis.
The MammaPrint test examines the genetic profile of the tumor. By analyzing 70 genes and 465 reference genes, it helps identify which breast cancer patients may not need unnecessary chemotherapy.
In a study conducted in Europe using the MammaPrint test, it was concluded that chemotherapy was not needed in 46% of early-stage high-risk breast cancer cases.¹
If clinical evaluations indicate a high risk of tumor recurrence, but the MammaPrint test indicates low risk, chemotherapy is not recommended for the patient.
With the BluePrint molecular subtyping test, 80 genes are analyzed to determine whether the breast cancer is Luminal type (A or B), Basal type, or HER2 type. This helps ensure that the breast cancer patient receives the most appropriate treatments.
In the MINDACT study, 64% of all early-stage breast cancer patients were identified as low risk with the MammaPrint test.
Are MammaPrint and BluePrint Tests Suitable for Me?
- If your cancer is at an early stage (Stage 1 or Stage 2)
- If your Estrogen Receptor (ER) is positive
- If you are HER2 (cerb-B2) negative
- If your tumor diameter is 5 cm or smaller
- If your lymph node involvement is negative or 1-3 positive
- If you are premenopausal, postmenopausal, or in menopause
Results are reported as Low Risk or High Risk. There is no Gray Area or Intermediate Risk result.
Low Risk
If you are Low Risk according to the result of the MammaPrint test;
You are at low risk for cancer recurrence and you are not expected to gain significant benefit from chemotherapy.
In patients with MammaPrint Low Risk results, the 5-year rate of remaining free from cancer recurrence was 94.4% with endocrine therapy and radiotherapy alone, while this rate was 95.9% when chemotherapy was added to the treatment. The 1.5% difference between these rates was not statistically significant.
Long-term follow-up data from the MINDACT Study were presented at the ASCO 2020 meeting.
With approximately 9 years of follow-up data, the 1.5% difference decreased to 0.9%. In light of these data, patients with MammaPrint Low Risk results were protected from receiving unnecessary chemotherapy and experiencing its side effects.²
High Risk
If you are High Risk according to the result of the MammaPrint test, this means chemotherapy may be added to your treatment and that you may potentially benefit from chemotherapy.
The results of the MammaPrint test, reported as Low Risk or High Risk, eliminate the uncertainty of Intermediate Risk or Gray Area results, which may be encountered in up to 39% of other genomic tests.
According to the Results of the Prospective PROMIS Study Presented at ASCO 2016;
The MammaPrint test was performed on 840 early-stage breast cancer patients who had undergone another genomic test and received an Intermediate or Gray Zone result. Of these patients, 45% were found to be Low Risk and 55% were found to be High Risk. Patients with Gray Zone results were almost equally classified as low risk and high risk with MammaPrint.
The MammaPrint test provides patients with definitive results.³
The MammaPrint test is FDA approved.
The MammaPrint test, performed using a paraffin tumor block, is an FDA-approved test.
The NCCN Guideline Recommends the MammaPrint Test at Category 1 Level.
The NCCN recommends the MammaPrint Breast Cancer Recurrence Test at Category 1 level for early-stage breast cancer patients, including ER-positive, lymph node-negative, or lymph node-positive (LN +1/+3) patients.
Recommended by Expert Clinical Practice Guidelines
MammaPrint has been included in numerous clinical practice guidelines developed by globally recognized cancer organizations. Clinical guidelines are evidence-based treatment recommendations for healthcare professionals involved in patient management. Guidelines aim to improve the quality of care and services based on the most current peer-reviewed documents.
References
1-Cardosa F, van’t Veer LJ, Bogaerts J et al. 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer. N Engl J Med 2016; 375:717-29.
2-Wuerstlein R, et al. Results of multigene assay (MammaPrint®️) and molecular subtyping (BluePrint®️) substantially impact treatment decision making in early breast cancer: Final analysis of the WSG PRIMe Decision Impact Study. Poster presented at San Antonio Breast Cancer Symposium. December 2016; San Antonio, Texas
3-Tsai M., et al. The 70-gene signature provides risk stratification and treatment guidance for patients classified as intermediate by the 21-gene assay. (PROMIS). Poster; ASCO 2016
BluePrint 80-Gene Molecular Subtyping Test
The BluePrint Molecular Subtyping Test determines whether breast cancer is Luminal Type (A or B), Basal Type, or HER2 Type.
In breast cancer treatment, the subtype of breast cancer differs in terms of long-term outcome, aggressive tumor grade, and response to chemotherapy. The BluePrint test analyzes 80 genes to determine the molecular subtype of breast cancer. In this way, it classifies the tumor in the most accurate way in terms of long-term prognosis and response to systemic therapy.
While traditional subtyping methods such as IHC or FISH examine cell surface receptor characteristics and may not provide sufficient information about tumor behavior, the BluePrint Molecular Subtyping Test determines which genes are actually driving the tumor’s behavior and provides in-depth information about how the tumor may behave. With the subtype information provided by BluePrint, physicians can make more informed decisions about a patient’s specific treatment options and personalize treatment accordingly.
In the NBRST study conducted in 2017⁴, it was understood that performing the BluePrint molecular subtyping test alongside the MammaPrint test helped predict the patient’s prognosis more accurately and contributed more to treatment selection when compared with traditional methods such as IHC/FISH.
When the BluePrint test was performed on cases classified by traditional methods such as IHC or FISH, 22% of patients were reclassified, revealing an opportunity to personalize treatment according to the patient’s molecular profile.
Luminal-Type cancers are primarily driven by estrogen and progesterone hormone pathways. This subtype is further classified using MammaPrint as Luminal A-Type cancers (Low Risk) and Luminal B-Type cancers (High Risk). These luminal subtypes have distinctly different outcomes, and therefore this information should be included in treatment planning to maximize the likelihood of improving the patient’s outcome.
HER2-Type cancers are primarily driven through the HER2 pathway. This molecular subtype does not always match IHC or FISH HER2 results; however, HER2-Type patients respond very well to HER2-targeted therapies in the neoadjuvant setting. In fact, with advances in therapeutics, HER2-Type patients have good long-term outcomes when treated with HER2-targeted agents.
Basal-Type tumors are not driven by ER, PR, or HER2 pathways and clinically resemble triple-negative tumors more closely. This molecular subtype is more aggressive, and patients may benefit from standard or emerging treatments for triple-negative breast cancers. Given the aggressive nature of these tumors, suitable patients may benefit from neoadjuvant therapy rather than adjuvant therapy.
In the NBRST Study, when the BluePrint test was performed on cases classified by traditional methods such as IHC or FISH, 22% of patients were reclassified, revealing an opportunity to personalize treatment according to the patient’s molecular profile.⁴
Detailed analysis, evaluation, and more effective treatment delivery
With the results of MammaPrint and BluePrint combined with clinical factors, physicians gain more comprehensive information to estimate prognosis and the benefit of specific treatments.
References
1.Krijgsman O, Roepman P, Zwart W, et al. A diagnostic gene profile for molecular subtyping of breast cancer associated with treatment response. Breast Cancer Res Treat. 2012; 133:37-47
2. Groenendijk FH, et al. NPJ Breast Cancer. 2019;5:15.
3. Rong P et. al. Cancer Res 2018;78(13 Suppl):Abstract nr 2612.
4. Whitworth, et al. Ann Surg Oncol (2017) 24:669–675
