Breast Cancer Index Test for Breast Cancer

Not currently recruiting at 111 trial locations

Overseen By Brandon N O'Neal, MS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Biotheranostics, Inc.

Must be taking: Endocrine therapy

Disqualifiers: Metastatic disease, Metaplastic cancer, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study how the Breast Cancer Index (BCI) test can guide treatment decisions for women with early-stage hormone receptor-positive breast cancer. The BCI test assesses the risk of cancer recurrence and the potential benefits of continuing hormone therapy. Women who have had hormone receptor-positive breast cancer, completed 4–7 years of hormone therapy, and do not have cancer spread to other parts of the body may be suitable candidates for this trial. The goal is to better understand treatment outcomes, medication habits, and quality of life for these patients. As an unphased trial, this study offers patients the opportunity to contribute to research that could improve future treatment strategies.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Breast Cancer Index (BCI) Test is safe?

Research has shown that the Breast Cancer Index (BCI) test is well-known and safe for patients with early-stage, hormone receptor-positive (HR+) breast cancer. Studies have demonstrated that it predicts the likelihood of cancer returning and assesses the benefit of continuing hormone therapy. Importantly, the BCI test is a diagnostic tool that evaluates risk without involving any medication or procedures. Therefore, it presents no side effects or safety concerns. The primary purpose of the BCI test is to aid in making treatment decisions safely and effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Breast Cancer Index (BCI) Test because it offers a personalized approach to managing breast cancer treatment. Unlike the standard hormone therapies or chemotherapy, which are broadly applied, the BCI Test assesses the risk of recurrence and potential benefit from extended endocrine therapy for each patient. This means doctors can tailor treatment plans based on a patient's unique cancer profile, potentially sparing them from unnecessary treatments and their associated side effects. By providing this level of individualized insight, the BCI Test could significantly improve outcomes and quality of life for breast cancer patients.

What evidence suggests that the Breast Cancer Index (BCI) Test is effective for hormone receptor-positive early-stage breast cancer?

Research has shown that the Breast Cancer Index (BCI) test, which participants in this trial will undergo, helps predict which patients with early-stage, hormone receptor-positive (HR+) breast cancer will benefit from extended hormone therapy. Studies have found that BCI can identify patients who may benefit from taking medications like tamoxifen for more than the usual five years. It is the only test proven to predict the need for extended hormone therapy, aiding doctors in deciding whether to continue treatment. Specifically, patients with certain BCI scores demonstrated a noticeable decrease in the risk of cancer returning when they maintained therapy. National cancer guidelines recognize the BCI test for its effectiveness in managing early-stage breast cancer. ^{2 5 6 7 8}

Who Is on the Research Team?

Joyce A O'Shaughnessy, MD

Principal Investigator

US Oncology Network

Kai Treuner, PhD

Principal Investigator

Biotheranostics, Inc.

Amanda KL Anderson, PhD

Principal Investigator

Biotheranostics, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

Early stage (I, II or III) female breast cancer patients, who have completed 4-7 years of primary adjuvant endocrine therapy

Patient was diagnosed with invasive breast carcinoma (ductal, lobular, or mixed ductal/lobular).

The primary tumor was hormone receptor positive (HR+), i.e. estrogen receptor-positive and/or progesterone receptor-positive.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

BCI Testing and Decision Impact

BCI testing is performed and results are discussed with patients to decide on extended endocrine therapy

1-2 weeks

1 visit (in-person)

Extended Endocrine Therapy

Participants undergo extended endocrine therapy based on BCI test results

5 years

Annual follow-up visits

Follow-up

Participants are monitored for medication adherence and clinical outcomes

5 years

Routine follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Breast Cancer Index (BCI) Test

How Is the Trial Designed?

Group I: Breast Cancer Index (BCI) Risk of Recurrence & Extended Endocrine Benefit Testing Experimental Treatment 1 Intervention

Female patients diagnosed with hormone receptor-positive (HR+), lymph node-negative (LN-) or lymph node-positive (LN+, with 1-3 positive nodes) early-stage invasive breast cancer, who are distant recurrence-free.

Who Is Running the Clinical Trial?

Biotheranostics, Inc.

Lead Sponsor

Trials

2

Recruited

3,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9306281/

Breast Cancer Index Is a Predictive Biomarker of Treatment ... Novel findings demonstrate that BCI (H/I) significantly predicts benefit from extended tamoxifen in HR + N + patients with HER2 − disease.

2. hologic.com hologic.com/hologic-products/tests/breast-cancer-index

Breast Cancer Index The Breast Cancer Index test is validated and recognized by national oncology guidelines for early-stage, HR+ breast cancer patients.

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e13083

Use of Oncotype vs. Breast Cancer Index (BCI) for ... Oncotype DX may be more useful to give prognosis in the early adjuvant period whereas BCI is more useful to evaluate late recurrence risk.

4. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2822321

Breast Cancer Index in Premenopausal Women With Early ... Patients with tumors classified as BCI(H/I)-low exhibited a 12-year absolute benefit in BCFI of 11.6% from exemestane plus OFS (HR, 0.48 [95% CI ...

5. breastcancerindex.com breastcancerindex.com/press-release-page-1210

New Data Supporting Breast Cancer Index Testing Breast Cancer Index is the only test validated to predict which patients will benefit from endocrine therapy beyond 5 years, helping inform the decision of 5 vs ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38437792/

Impact of the Breast Cancer Index for Extended Endocrine ... The Breast Cancer Index (BCI) test assay provides an individualized risk of late distant recurrence (5-10 years) and predicts the likelihood ...

7. breastcancerindex.com breastcancerindex.com/BTNBCI_1423450-BCI-Pilot%20Sales-Aid_Digital_2-18.pdf

Anti-estrogen therapy may cause side effects that impact ... The BCI test provides: 1) a quantitative estimate of the risk for both late (post-5 years from diagnosis) distant recurrence and of the cumulative distant ...

8. onclive.com onclive.com/view/the-breast-cancer-index-impacts-physicians-decision-to-extend-endocrine-therapy-for-hr-early-stage-disease

The Breast Cancer Index Impacts Physicians' Decision to ... The BCI test provides an individualized risk of late distant recurrence—5 to 10 years—and predicts whether a patient with HR-positive, early- ...