Diagnostic MRI + Gene Expression for Breast Cancer

Recruiting at 75 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: ECOG-ACRIN Cancer Research Group

Must not be taking: Hormonal therapy

Disqualifiers: Bilateral disease, BRCA mutations, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

368 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This clinical trial studies magnetic resonance imaging (MRI) and gene expression in diagnosing patients with abnormal cells in the breast duct that have not spread outside the duct. MRI uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. MRI may help find and diagnose patients with breast cancer. It may also help doctors predict a patient's response to treatment and help plan the best treatment. Genetic studies may help doctors predict the outcome of treatment and the risk for disease recurrence. Performing MRI with genetic studies may help determine the best treatment for patients with breast cancer in situ.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must not have taken hormonal therapy for breast cancer prevention within 3 months before the biopsy or had chemotherapy within 6 months prior to joining the trial.

Is the combination of MRI and gene expression analysis for breast cancer safe?

The studies reviewed focus on the use of MRI and hormone therapies in breast cancer, indicating that these methods are generally used safely in clinical settings. However, specific safety data for the combination of MRI and gene expression analysis in breast cancer is not directly addressed in the provided research. ^{1 2 3 4 5}

How is endocrine therapy for breast cancer different from other treatments?

Endocrine therapy (hormone therapy) for breast cancer is unique because it targets hormone receptors to slow or stop the growth of cancer cells that rely on hormones like estrogen or progesterone. Unlike chemotherapy, which attacks all rapidly dividing cells, endocrine therapy specifically interferes with the cancer's ability to use hormones, making it a more targeted approach. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Diagnostic MRI + Gene Expression for Breast Cancer?

Research shows that MRI can help determine the best treatment approach for breast cancer by accurately assessing tumor characteristics and response to therapy, especially in hormone receptor-positive cases. This can guide the use of therapies like endocrine therapy, which is effective in managing hormone receptor-positive breast cancer. ^{2 9 10 11 12}

Who Is on the Research Team?

Constance Lehman

Principal Investigator

ECOG-ACRIN Cancer Research Group

Are You a Good Fit for This Trial?

This trial is for women with a confirmed diagnosis of ductal carcinoma in situ (DCIS) of the breast, who have not had invasive breast cancer or DCIS before, and haven't received chemotherapy or hormonal therapy recently. They must be able to undergo MRI with contrast and are considering surgical options like lumpectomy or mastectomy. Participants should not be pregnant, breastfeeding, or planning to become pregnant.

Inclusion Criteria

I do not have harmful BRCA gene mutations.

Women who could become pregnant must have a recent test to make sure they are not pregnant before joining the study.

Patients will be staged prior to registration according to the clinical staging criteria adapted from the American Joint Committee on Cancer (AJCC) Cancer Staging Data Forms of the AJCC Cancer Staging Manual, 7th Edition, 2009

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgical MRI

Patients undergo MRI prior to surgery to assess the extent of disease and determine surgical approach

1-2 weeks

1 visit (in-person)

Surgical Treatment

Patients undergo either mastectomy or wide local excision based on MRI findings

4-6 weeks

1-2 visits (in-person)

Post-surgical Treatment

Patients receive endocrine therapy and/or radiation therapy based on DCIS score

6-12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

Every 6 months for 5 years, then annually for 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Endocrine Therapy
• Magnetic Resonance Imaging
• Radiation Therapy
• Therapeutic Conventional Surgery
• Therapeutic Surgical Procedure

Trial Overview The study is examining if combining MRI scans with gene expression analysis can improve diagnosis and treatment planning for patients with DCIS. It aims to see whether these methods can predict treatment response and recurrence risk better than current practices.

How Is the Trial Designed?

Group I: Arm E (radiation therapy, endocrine therapy) Experimental Treatment 4 Interventions

Patients undergo radiation therapy and endocrine therapy as directed.

Group II: Arm D (endocrine therapy) Experimental Treatment 4 Interventions

Patients undergo endocrine therapy as directed.

Group III: Arm C (wide local excision) Experimental Treatment 4 Interventions

Patients undergo wide local excision +/- re-excision. Patients may cross-over to Arm B if mastectomy is indicated. Tissue samples collected during surgery are used to calculate the DCIS score using genetic analysis testing. Patients may then proceed to Step 3.

Group IV: Arm B (mastectomy) Experimental Treatment 4 Interventions

Patients undergo a mastectomy. Patients do not register for Step 3.

Group V: Arm A (MRI) Experimental Treatment 4 Interventions

Patients undergo MRI prior to surgery. Patients undergo additional imaging and/or biopsies if indicated based on MRI.

Endocrine Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Hormone Therapy for:

• Breast cancer
• Prostate cancer
• Endometrial cancer
• Ovarian cancer

Approved in United States as Hormone Therapy for:

• Breast cancer
• Prostate cancer
• Endometrial cancer
• Ovarian cancer

Approved in Canada as Hormone Therapy for:

• Breast cancer
• Prostate cancer
• Endometrial cancer
• Ovarian cancer

Approved in Japan as Hormone Therapy for:

• Breast cancer
• Prostate cancer
• Endometrial cancer
• Ovarian cancer

Approved in China as Hormone Therapy for:

• Breast cancer
• Prostate cancer
• Endometrial cancer
• Ovarian cancer

Approved in Switzerland as Hormone Therapy for:

• Breast cancer
• Prostate cancer
• Endometrial cancer
• Ovarian cancer

Who Is Running the Clinical Trial?

ECOG-ACRIN Cancer Research Group

Lead Sponsor

Trials

122

Recruited

160,000+

Eastern Cooperative Oncology Group

Collaborator

Trials

272

Recruited

153,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

[18F]fluoroestradiol (FES) PET is an FDA-approved imaging tool that can predict how well patients with cancer will respond to endocrine therapy, similar to traditional immunohistochemistry (IHC) methods.

Recent research indicates that measuring tumor heterogeneity with FES can help forecast clinical benefits and track the effectiveness of estrogen receptor blockade during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Molecular Imaging Find a Path to Navigate Evolving Breast Cancer Treatments? Linden, HM., Mankoff, DA.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Breast carcinoma: effect of preoperative contrast-enhanced MR imaging on the therapeutic approach. [2022]

2. Australia pubmed.ncbi.nlm.nih.gov

Evaluating the role of magnetic resonance imaging post-neoadjuvant therapy for breast cancer in the NEONAB trial. [2018]

3. China pubmed.ncbi.nlm.nih.gov

Magnetic resonance differential analysis for different hormone receptor expression status in HER-2-positive breast cancer. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

18F-FDG PET/CT in the Staging and Management of Breast Cancer: Value in Disease Outcome and Planning Therapy. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging for screening, diagnosis, and eligibility for breast-conserving surgery: promises and pitfalls. [2010]

6. Ireland pubmed.ncbi.nlm.nih.gov

Are contralateral parenchymal enhancement on dynamic contrast-enhanced MRI and genomic ER-pathway activity in ER-positive/HER2-negative breast cancer related? [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Effects of tamoxifen and aromatase inhibitors on breast tissue enhancement in dynamic contrast-enhanced breast MR imaging: a longitudinal intraindividual cohort study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Can Molecular Imaging Find a Path to Navigate Evolving Breast Cancer Treatments? [2023]

9. United States pubmed.ncbi.nlm.nih.gov

The effect of acute aromatase inhibition on breast parenchymal enhancement in magnetic resonance imaging: a prospective pilot clinical trial. [2015]

10. Italy pubmed.ncbi.nlm.nih.gov

Multiparametric MRI-based radiomics analysis for prediction of breast cancers insensitive to neoadjuvant chemotherapy. [2020]

11. China pubmed.ncbi.nlm.nih.gov

[Breast cancer subtypes based on ER/PR and Her2 expression: comparison of MR imaging features]. [2014]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Radiogenomics analysis reveals the associations of dynamic contrast-enhanced-MRI features with gene expression characteristics, PAM50 subtypes, and prognosis of breast cancer. [2022]