Hologic Presents New Data on Breast Cancer Index® Test at ASCO 2025

Analysis reveals significant industry trends and economic implications

Release Date

2025-05-23

Category

Clinical Trial Event

Reference

Source

Breakthrough Clinical Results

Hologic announced new data on the Breast Cancer Index® (BCI®) test, to be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The data, from a study of over 2,800 patients with early-stage, hormone receptor-positive (HR+) breast cancer, showed that BCI testing led to a change in treatment recommendations for approximately 40% of cases. The test helps predict the likelihood of benefit from extended endocrine therapy, improving physician confidence and patient comfort with treatment decisions. Two abstracts will be presented, one focusing on the overall impact of BCI testing and another on its use in premenopausal women.

Key Highlights

  • New data on the Breast Cancer Index® (BCI®) test will be presented at ASCO 2025.
  • BCI testing influenced treatment recommendations for about 40% of patients in a study of over 2,800 with early-stage, HR+ breast cancer.
  • The test improves physician confidence and patient comfort with treatment decisions.
  • Two abstracts will be presented at ASCO, one focusing on overall impact and another on premenopausal women.

Incidence and Prevalence

Global Breast Cancer Incidence and Prevalence

Breast cancer stands as the most commonly diagnosed cancer and the leading cause of death in women worldwide. It ranks as fifth in the world as a cause of cancer death overall in developed countries and is the second most frequent cause of cancer death in women.

Breast cancer ranks as one of the most prevalent malignancies across the globe. The importance of early detection cannot be overstated, as early diagnosis increases 5-year survival rates up to 95%.

There are notable racial/ethnic disparities in incidences and distributions of breast cancer subtypes:

  • The annual incidence rate of all breast cancers was 31.3 (95% CI, 31.2-31.5) per 100,000 people in non-Hispanic White women (the reference group)
  • The incidence rate was higher in Black women (IRR, 1.04; 95% CI, 1.02-1.05; P<.001) compared to non-Hispanic White women

  • Lower incidence rates were observed in:

  • Asian/Pacific Islander (IRR, 0.90; 95% CI, 0.89-0.92; P<.001)

  • American Indian/Alaskan native (IRR, 0.82; 95% CI, 0.81-0.83; P<.001)

  • Hispanic White women (IRR, 0.79; 95% CI, 0.75-0.83; P<.001)

When examining breast cancer subtypes, significant disparities exist:

  • In Black patients, the incidences of certain subtypes were higher than in non-Hispanic White patients:

  • HR-positive and ERBB2-positive (IRR, 1.12)

  • HR-negative and ERBB2-positive (IRR, 1.46)

  • Triple-negative breast cancer (TNBC) (IRR, 2.07)

  • However, the incidence of HR-positive and ERBB2-negative subtype in Black women was lower (IRR, 0.86) than in non-Hispanic White women

Research has identified four main "intrinsic subtypes" of breast cancer through gene expression: - Luminal A - Luminal B - HER2-enriched - Basal-like

It's important to note that breast cancer is heterogeneous and differs substantially across different tumors (intertumor heterogeneity) and even within an individual tumor (intratumor heterogeneity).

Key Unmet Needs and Target Populations in Breast Cancer

Unmet Needs in Breast Cancer

Several critical unmet needs exist in breast cancer research and treatment based on recent publications:

Triple-Negative Breast Cancer Challenges

  • Comprises approximately 10-20% of all breast carcinomas
  • Characterized by aggressive nature with shorter disease-free and overall survival
  • Lacks available targeted therapies
  • Patients receive cytotoxic chemotherapy regimens that are toxic and ineffective for long-term response
  • Shows marked heterogeneity at both morphologic and molecular levels, making identification of appropriate molecular targets challenging
  • Approximately 12-35% of triple-negative breast cancers express androgen receptor

Metastasis and Drug Resistance

  • Represent the biggest challenges in breast cancer treatment

  • Research focuses on:

  • Molecular evaluation

  • Mechanism studies

  • Screening of therapeutic targets

  • Factors leading to inflammatory infiltration and immune system suppression in the tumor microenvironment are potential therapeutic targets
  • Interleukin-1 cytokines drive the formation of an inflammatory/immunosuppressive microenvironment potentially involved in metastasis and drug resistance

Limitations of Current Clinical Therapies

  • Metastasis and recurrence remain problematic
  • Poor quality of life for patients
  • Need for new therapeutic drugs to meet clinical demand

  • Traditional treatments:

  • Cannot eliminate every cancer cell

  • May kill normal cells due to inaccurate targeting

  • Dose-dependent cardiotoxicity of anthracyclines, which are among the most effective chemotherapy agents
  • Gap in cardiotoxicity prevention drugs

Biomarker Development Needs

  • Need for biomarkers related to prognosis of early breast cancer
  • Need for improved biomarkers to inform better patient selection for treatment with checkpoint inhibition
  • CENPM as a potential biomarker for immunotherapy efficacy

Target Populations in Breast Cancer Research

Research and treatment efforts are specifically focusing on several key populations:

By Breast Cancer Subtype

  • Triple-negative breast cancer patients (represents approximately 15-20% of breast cancer patients)
  • Patients with androgen receptor (AR) positive triple-negative breast cancer
  • Patients with basal-like breast cancer

By Genetic and Molecular Characteristics

  • Patients with germline BRCA mutation associated breast cancer (gBRCAm-BC)
  • Patients with programmed death-ligand 1 (PD-L1+) advanced triple-negative breast cancer

By Disease Stage

  • Patients with metastatic breast cancer
  • Patients with early basal-like breast cancer

By Geographic Region

  • Women in Japan (through cancer screening programs)

Emerging Therapeutic Approaches

Ongoing research is exploring improved therapeutic approaches including: - Alternative compounds like capsaicin showing anticarcinogenic activities - Benzo[a]phenoxazine derivatives with potential anticancer activity - Targeting lysosomes in cancer cells as a therapeutic approach

BCI Test Trials for Non-Breast Cancer Indications

Based on the provided context, there is no information available about the Breast Cancer Index® (BCI®) test being trialed for indications other than breast cancer. The context only mentions the Breast Cancer Index in relation to breast cancer treatment, specifically:

  • As part of a combination with DetermaIO (an immune-related 27-gene expression signature)
  • In guidelines for patients with ER-positive disease where "clinicians may consider using a Breast Cancer Index (H/I) high assay result to support a decision to extend adjuvant endocrine therapy"
  • As one of several multigene profiling assays used in early-stage estrogen receptor (ER)-positive/human epidermal growth factor 2 (HER2)-negative breast cancer

While the context does mention that DetermaIO (which was tested in combination with BCI) was investigated for its predictive impact in metastatic colorectal cancer (mCRC) in the AtezoTRIBE study, there is no specific indication that BCI itself was being tested for colorectal cancer applications.

The information provided does not contain details about intervention models for BCI trials in non-breast cancer indications.