Guideline: Can MammaPrint guide treatment decisions?
Summary
The American Society of Clinical Oncology (ASCO) updated its guidelines for MammaPrint, a genomic tumor test that guides treatment decisions for patients with early-stage invasive breast cancer. The update was based on results from the MINDACT study (11/16/17).
Relevance
This article is most relevant for Women diagnosed with ER-positive, Her2-negative early-stage breast cancer with 0-3 positive nodes
Relevance: Medium-High
Research Timeline: Post Approval
Media Ratings
Who covered this study?
Medpage Today
ASCO panel backs gene assay for breast cancer
This article rates 4.5 out of 5 stars
Agendia Press Release
Agendia’s MammaPrint® recommended by ASCO breast cancer guideline in focused update based on landmark MINDACT Trial data
This article rates 3.0 out of 5 stars
Contents
| At a glance | Clinical trials |
| Findings | In-depth |
| Guidelines | Limitations |
| Questions for your doctor | Resources |
STUDY AT A GLANCE
This study is about:
The use of MammaPrint to guide treatment decisions on the use of for patients with invasive breast cancer.
Background:
The "Microarray in Node-Negative and 1 to 3 Positive Lymph Node Disease May Avoid Chemotherapy" (MINDACT) is a study that looked at almost 7,000 European women with invasive breast cancer. Researchers compared participants’ risk of recurrence using two separate means:
- Clinical risk of recurrence using a program called ! Online
- Genomic risk of recurrence to determine risk for recurrence using MammaPrint—a tumor that looked at 70 genes within the tumor tissue.
Participants with discordant clinical and genomic risk (either high clinical risk and low genomic risk or low clinical risk and high genomic risk) were randomly assigned to have chemotherapy or not. Results from the MINDACT study published August 2016 in the New England Journal of Medicine showed that 94.7% of patients with high clinical risk but low genomic risk as assessed by MammaPrint who did not receive chemotherapy were alive without distant at 5 years. This is 1.5% fewer than the number of similar patients who received chemotherapy, demonstrating that chemotherapy does not provide benefit for the vast majority of these patients.
Why is this study important?
Reducing overtreatment in patients with breast cancer is important. Based on the results of this research, the American Society of Clinical Oncology (ASCO) updated their Clinical Practice Guidelines. ASCO guidelines are regularly updated when new, potentially practice-changing data is published.
Study finding:
The MINDACT study showed that the MammaPrint test could predict which patients will have a favorable prognosis without .
What does this mean for me?
Different tumor tests are available for treatment decision-making in people with hormone receptor-positive (ER–positive and PR-positive), breast cancer, including MammaPrint and Oncotype Dx.
The MammaPrint test is appropriate for patients with hormone receptor-positive breast cancer with 0-3 positive for whom ! Online predicts a high clinical risk. However, no test is perfect. Some patients in the MINDACT study developed recurrent disease, even though MammaPrint testing suggested otherwise; other patients with poor MammaPrint scores remain disease free, even without chemotherapy.
If you have recently been diagnosed with invasive breast cancer, your physician may recommend tumor testing to determine if you would benefit from chemotherapy. Based on the results, you may choose to forego .
Posted 11/16/17
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References
Krop I, Ismaila N, Andre F, et al. “Use of Biomarkers to Guide Decisions on Systemic Therapy for Women With Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Focused Update.” Journal of Clinical Oncology 35, no. 24 (August 2017) 2838-2847.
Harris L, Ismaila N, McShane L, et. al. "Use of Biomarkers to Guide Decisions on Systemic Therapy for Women With Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline." Journal of Clinical Oncology 34, no. 10 (April 2016) 1134-1150.
Cardosa F, Van t’ veer LJ, Boegerts J, et al. “70-Gene Signature as an Aid to Treatment Decisions in Breast Cancer.” New England Journal of Medicine 2016; 375:717-729 August 25, 2016.
Disclosure
FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.
This article is relevant for:
Women diagnosed with ER-positive, Her2-negative early-stage breast cancer with 0-3 positive nodes
This article is also relevant for:
people with breast cancer
people with ER/PR + cancer
people newly diagnosed with cancer
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IN-DEPTH REVIEW OF RESEARCH
Study background:
From 2001 to 2007 researchers organized a large trial in Europe to see whether a commercial genomic tumor test called MammaPrint could reduce overtreatment with chemotherapy in patients with invasive breast cancer. More than 6,600 women participated at 112 institutions in 9 nations. Each participant’s clinical risk of cancer recurrence was determined using a web-based tool called ! Online. Patient’s tumors were also tested using MammaPrint, which produced a genomic score. Participants with discordant clinical and genomic risk (either high clinical risk and low genomic risk or low clinical risk and high genomic risk) were randomly assigned to receive or not. The results, which were published in the New England Journal of Medicine in August 2016, suggest that approximately 46% of women with breast cancer who are at high clinical risk for recurrence might not benefit from . As a result, ASCO updated guidelines on the use of MammaPrint to guide decisions on the use of in an ASCO Special Article published in the Journal of Clinical Oncology in August, 2017.
Researchers of this study wanted to know:
Can MammaPrint, a commercially available , help to reduce overtreatment in patients with breast cancer?
Population(s) looked at in the study:
MINDACT was a trial that looked at 6,693 women with operable invasive breast cancer, 0 to 3 positive , and no distant metastases. Eligible patients were women between the ages of 18 and 70. Initially, only patients with node-negative disease were enrolled; however, the study was later amended in 2009 to include women with 1 to 3 positive nodes. Researchers determined participants’ clinical risk (using a modified version of ! Online), genomic risk (using MammaPrint) and tumor samples.
The patients were divided into 4 main groups according to their clinical and genomic risk, and received either or no therapy:
- Low clinical risk and low genomic risk: 2,745 patients (41.0%)
- No therapy
- Low clinical risk and high genomic risk: 592 patients (8.8%)
- to chemotherapy or no chemotherapy
- High clinical risk and low genomic risk: 1,550 patients (23.2%)
- to chemotherapy or no chemotherapy
- High clinical risk and high genomic risk: 1,806 patients (27.0%)
Study findings:
Among women with breast cancer who were at high clinical risk and low genomic risk for recurrence and did not receive chemotherapy, the 5-year survival rate was 94.7%; the survival rate for those who did receive chemotherapy was 96.2%. This difference of 1.5 percentage points suggests that approximately 46% of women with invasive breast cancer who are at high clinical risk and low genomic risk do not receive benefit from .
Conclusions:
ASCO used the results of the MINDACT trial to revise its clinical guidelines regarding the use of MammaPrint for decision making regarding use of for patients with invasive breast cancer. MammaPrint may inform patients with ER-positive or PR-positive, breast cancer and 0-3 positive and their clinicians whether or not to forego . Although MammaPrint can be used to identify patients with high clinical risk who may receive limited benefit from chemotherapy, women with low clinical risk of recurrence did not benefit from chemotherapy, regardless of their MammaPrint risk group. Thus, ASCO does not recommend the use of MammaPrint for patients with low clinical risk.
Posted 11/16/17
References
Krop I, Ismaila N, Andre F, et al. “Use of Biomarkers to Guide Decisions on Systemic Therapy for Women With Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Focused Update.” Journal of Clinical Oncology 35, no. 24 (August 2017) 2838-2847.
Harris L, Ismaila N, McShane L, et. al. "Use of Biomarkers to Guide Decisions on Systemic Therapy for Women With Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline." Journal of Clinical Oncology 34, no. 10 (April 2016) 1134-1150.
Cardosa F, Van t’ veer LJ, Boegerts J, et al. “70-Gene Signature as an Aid to Treatment Decisions in Breast Cancer.” New England Journal of Medicine 2016; 375:717-729 August 25, 2016.
Expert Guidelines
TNational Comprehensive Cancer Network (NCCN) guidelines recommend the following for tumor testing in , , ER-positive breast cancer:
Premenopausal women:
Oncotype Dx testing and the following treatments are recommended:
- No positive and tumors greater than 0.5 cm:
- For people with an Oncotype Dx recurrence score of 15 or lower:
- Recommend hormone therapy.
- Consider medications to suppress ovaries.
- Consider 3-5 years of bisphosphonate therapy
- For people with an Oncotype Dx recurrence score of 16-25:
- Recommend either hormone therapy plus medications to suppress ovaries or chemotherapy followed by hormone therapy.
- Consider 3-5 years of bisphosphonate therapy.
- For people with an Oncotype Dx recurrence score of 26 or higher:
- Recommend chemotherapy followed by hormone therapy
- Consider 3-5 years of bisphosphonate therapy
- For people with an Oncotype Dx recurrence score of 15 or lower:
- Micrometastasis to of 2 mm or smaller or 1-3 positive lymph nodes:
- Consider Oncotype Dx testing if a candidate for chemotherapy.
- Recommend either hormone therapy plus medications to suppress ovaries or chemotherapy followed by hormone therapy.
- Consider 3-5 years of bisphosphonate therapy.
The NCCN notes that data are limited about the use of Oncotype Dx in men. Available data suggest that the test provides prognostic information for men.
Updated: 11/13/2023
Questions To Ask Your Doctor
- What is a versus a genetic test?
- What exactly is MammaPrint?
- Are you aware of the updated ASCO guidelines on using MammaPrint to guide treatment?
- Is MammaPrint a test I should consider based on my diagnosis and of breast cancer?
- What costs are associated with MammaPrint testing? Will my insurance cover it?
- What are the risks of overtreating my cancer? What are the risks of undertreating it?
- Does my MammaPrint score agree with my clinical risk score?
Open Clinical Trials
The following are studies enrolling people with early ER-positive, breast cancer.
- NCT03053193: MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles (FLEX). The FLEX Registry is a large-scale, population based, registry. All patients with I to III breast cancer who receive MammaPrint® and BluePrint testing on a primary breast tumor are eligible for entry into the FLEX Registry.
- NCT05607004: (Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer (EVANGELINE). This study is looking at drug called (Z)-endoxifen as a possible treatment for pre-menopausal women with ER+/HER2- breast cancer. (Z)-endoxifen is a type of hormone therapy that blocks the body's natural from binding to cancer cells.
- NCT04584255: Treating HER2-Negative Breast Cancer with a () and (Dostarlimab) in People with a or Mutation. This study will look at how well the drugs (a ) and Dostarlimab (an ) treat breast cancer in people with an inherited , or mutation.
- NCT03749421: Prosigna Assay on Clinical Decision-making in Women With HR+/Her2- Breast Cancer. This research study is evaluating a genomic analysis called Predictor Analysis of Microarray 50 (PAM50, by Prosigna®) as a tool to possibly guide the participant and the treating physician to choose the most personalized pre-operative treatment for breast cancer.
- NCT04567420: DNA-Guided Second Line Therapy For High Residual Risk, II-III, Hormone Receptor Positive, Negative Breast Cancer. This study will monitor people with , high-risk breast cancer for possible recurrence using a test called circulating tumor (). People who test positive for but who have no other signs of recurrence, will receive either the drugs palbociclib combined with fulvestrant or standard-of-care hormone therapy.
-
NCT04852887: De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA). This study evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy.
A number of other clinical trials for patients with breast cancer can be found here.
Updated: 02/01/2024
Related Resources
The following organizations have resources related to testing (tumor testing).
- FORCE related resources:
- Information: tests and cancer treatment
- Information: Common tests
- Information: damage repair and cancer treatment (including information on MMR)
- Video: Biomarkers and Liquid Biopsies
- XRAY category: Tumor testing
- Personalized portal: testing
- Cancer Support Community: Information on testing
- National Cancer Institute: Information on testing
Updated: 03/16/2022
Who covered this study?
Medpage Today
ASCO panel backs gene assay for breast cancer
This article rates 4.5 out of 5 stars
Agendia Press Release
Agendia’s MammaPrint® recommended by ASCO breast cancer guideline in focused update based on landmark MINDACT Trial data
This article rates 3.0 out of 5 stars
CBS SF Bay Area
MammaPrint identifies breast cancer patients who can skip chemotherapy
This article rates 1.5 out of 5 stars