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Prof. Dr. Mustafa Özdoğan · Medical Oncologist

Treatment Duration in Premenopausal Breast Cancer: The BCI Test (SABCS 2025)

Treatment Duration in Premenopausal Breast Cancer: The BCI Test (SABCS 2025)
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Treatment Duration in Premenopausal Breast Cancer: The BCI Test (SABCS 2025)

Extending endocrine therapy from 5 to 10 years or adding ovarian function suppression (OFST) is difficult in premenopausal ER+ early breast cancer. A major analysis of 11 studies presented at SABCS 2025 showed that the Breast Cancer Index (BCI) test outperforms 21-gene panels (RS) in predicting recurrence and personalizing treatment.

Patient Pool
1,200
Analysis of 11 Studies
Risk Separation (HR)
2.1
High Statistical Power
Low-Risk Group
92%
10-Year Recurrence-Free Survival
OFST Benefit
25%
Reduction in the High-Risk Group

1) What Is BCI (Breast Cancer Index)?

BCI analyzes the HOXB13/IL17BR (H/I) gene ratio and molecular grade index in breast tumor tissue. It is the only FDA-approved test specifically identifying late recurrence risk after year 5 of endocrine treatment and who benefits from extended therapy.

2) Study Design (SABCS 2025)

In this Hologic/Biotheranostics-led analysis:

  • Dataset: 11 studies, including SWOG S1007 and OPTIMA.
  • Population: Premenopausal, ER+, HER2-negative, node-positive/negative.
  • Aim: Compare 10-year distant recurrence-free survival (DRFS) by BCI score: Low <1.47 vs High ≥1.47.

3) 10-Year Distant Recurrence-Free Survival (DRFS)

By BCI Score
Low BCI Score
92%
High BCI Score
75%

Data Interpretation

Low-BCI patients have a low 10-year recurrence risk (8%) and may be spared extended-treatment side effects. In the high-score group, recurrence risk reaches 25%; these patients benefit most from OFST and extended therapy.

4) Summary Data Table

Parameter Value / Result Clinical Meaning
Predictive Power (HR) 2.1 (p<0.001) High BCI strongly predicts recurrence.
OFST Effect 25% Risk Reduction Significant only in the high-BCI group.
Comparison BCI > 21-Gene RS BCI is more sensitive than conventional tests in premenopausal patients.
Nodal Status 10% Difference in Node-Positive Patients Biology—genetics—determines risk even when lymph nodes are positive.

Clinical Impact and Safety

BCI is a laboratory test without physical side effects. However, adverse effects of treatment decisions based on it—OFST + aromatase inhibitor—matter.

Potential Gains:

  • De-escalation: Protects low-risk patients from unnecessary menopausal effects of OFST, such as hot flashes, osteoporosis, and sexual dysfunction.
  • Optimization: Provides a scientific basis for intensive treatment to prevent early recurrence in high-risk patients.

Frequently Asked Questions

1) When Should the Test Be Done?
Usually recommended approaching year 5, when deciding whether to stop or continue medication.
2) Is a New Biopsy Needed?
No. It uses tumor blocks collected at diagnosis and stored as FFPE.
3) Why Is the 21-Gene Test Not Enough?
21-gene tests such as Oncotype mainly determine chemotherapy needs in the first 5 years. BCI specializes in late recurrence and hormone-treatment duration.

DROZDOGAN Academy Commentary

SABCS 2025 data indicate the end of uniform treatment for premenopausal women. Even with positive lymph nodes, genetically low-risk tumors may allow patients to avoid aggressive ovarian suppression's adverse effects. Decisions must be made with a physician.

References

  1. Ravdin P, Graham C, et al. SABCS 2025, Oral Session 4 (OS4-12). "Breast Cancer Index in premenopausal ER+ early breast cancer: Pooled analysis".
  2. Albain KS, et al. J Clin Oncol. 2017. (Original BCI Validation).
  3. Francis PA, et al. N Engl J Med. 2015 (SOFT/TEXT Studies).

Note: This content is based on SABCS 2025 congress presentation data and is informational, not medical advice.

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