Diagnostic MRI + Gene Expression for Breast Cancer

Not currently recruiting at 81 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how MRI (a scan using radio waves and magnets) and genetic studies can aid in diagnosing breast cancer in its early stages, specifically when abnormal cells are present but haven't spread. The goal is to determine if these methods can better predict a patient's response to treatment and help plan the most effective treatment strategy. Participants may undergo various procedures, including MRI, mastectomy (breast removal surgery), endocrine therapy (hormone treatment), and radiation therapy. Suitable candidates include those diagnosed with ductal carcinoma in situ (a breast disease where abnormal cells are found in the lining of a breast duct) who do not have invasive cancer, have not had previous breast cancer, and can undergo an MRI. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could improve early breast cancer diagnosis and treatment strategies.

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.

What prior data suggests that MRI and gene expression are safe for diagnosing breast cancer?

Research has shown that hormone-blocking treatments, such as those that inhibit estrogen, can prevent the growth of some breast cancers. Although these treatments are generally manageable, about 93% of women experience side effects like hot flashes and joint pain. Despite these side effects, long-term use of these treatments can reduce the likelihood of cancer recurrence and lower the risk of death from breast cancer.

Radiation therapy is also safe for breast cancer patients, even when targeting nearby lymph nodes, which are part of the immune system. New techniques have made radiation more precise, protecting healthy tissue and making it a safer option for many patients.

In summary, both treatments have been thoroughly studied and are effective and safe, though side effects are common with hormone-blocking therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative approaches like using MRI and gene expression to guide breast cancer treatment decisions. Unlike standard treatments, which typically follow a one-size-fits-all approach, this trial aims to personalize treatment based on precise imaging and genetic analysis. This could lead to more accurate treatment choices, potentially improving outcomes and reducing unnecessary procedures. Additionally, by integrating endocrine therapy with advanced imaging techniques, there's hope to better tailor therapies to individual patient profiles, enhancing effectiveness and minimizing side effects.

What evidence suggests that this trial's treatments could be effective for diagnosing breast cancer?

Research has shown that hormone therapy, one of the treatments in this trial, effectively treats breast cancer. Studies have found that taking tamoxifen, a common hormone therapy drug, for 5 years can lower the risk of breast cancer recurrence by 40% and reduce the chance of death by 30%. Extending hormone therapy to 10 years can further improve results. Hormone therapy significantly increases survival rates in patients with ER-positive breast cancer, a type that grows when exposed to estrogen.

In this trial, some participants will receive radiation therapy, which evidence indicates helps control tumors in the breast and allows patients to live longer without cancer recurrence. Together, these treatments offer promising improvements for patients with breast cancer in situ. ^{2 6 7 8 9}

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10453164/

Extended Adjuvant Endocrine Therapy in Early Breast ... Taking tamoxifen for 5 years has been shown to reduce the risk of breast cancer recurrence by 40% and mortality by 30% compared to patients ...

2. esmoopen.com esmoopen.com/article/S2059-7029(25)00926-3/fulltext

Extended adjuvant endocrine therapy in early breast cancer 10 years of adjuvant ET is superior to 5 years in reducing recurrences. Seven to eight years of ET improves outcomes compared with 5 years.

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e12516

The impact of adjuvant endocrine therapy on outcomes in ... This study demonstrates that endocrine therapy significantly improves survival outcomes in patients with ER-low positive, HER2-negative breast cancer.

4. nature.com nature.com/articles/s41523-025-00746-7

Impact of endocrine therapy regimens for early-stage ER+ ... Endocrine therapy for breast cancer may reduce the risk of contralateral breast cancer (CBC). However, there are no published estimates ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2212856

Interrupting Endocrine Therapy to Attempt Pregnancy after ... These results suggest that although endocrine therapy for a period of 5 to 10 years substantially improves disease outcomes in patients with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11880597/

Side-effects in women treated with adjuvant endocrine ... Almost all current endocrine therapy users experienced side-effects (92.7 %), most frequent were vasomotor- and musculoskeletal symptoms.

7. bcrf.org bcrf.org/about-breast-cancer/hrt-breast-cancer-risk/

HRT and Breast Cancer Risk Explained | BCRF A 2021 review of systemic HRT in women with a history of breast cancer found that HRT significantly increased the risk of breast cancer recurrence, especially ...

8. cancer.org cancer.org/cancer/types/breast-cancer/treatment/hormone-therapy-for-breast-cancer.html

Hormone Therapy for Breast Cancer Some breast cancers grow in response to hormones like estrogen. Hormone therapy blocks these hormones, which keeps the cancer from growing.

9. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(25)01013-X/fulltext

Extending the duration of endocrine treatment for early ... The corresponding proportional reductions in breast cancer mortality rates are about 30% and 40%, and continue beyond year 10. Even after ...