Clinical trial · Observational
Breast Cancer Index (BCI) Registry
NCT04875351CI-TRIAL-00080492active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the Breast Cancer Index (BCI) Registry study is to conduct a large scale, population-based prospective registry to evaluate long-term clinical outcome, clinical impact, medication adherence and quality of life in hormone receptor positive (HR+) early-stage breast cancer patients receiving BCI testing as part of routine clinical care to inform extended endocrine therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast Cancer Index (BCI) Risk of Recurrence & Extended Endocrine Benefit Test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Breast Cancer Index (BCI) Risk of Recurrence & Extended Endocrine Benefit Testing
- description
- 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.
- interventionNames
- Diagnostic Test: Breast Cancer Index (BCI) Risk of Recurrence & Extended Endocrine Benefit Test
Primary outcomes (2)
- measure
- To determine BCI test performance by evaluating the long-term outcome of BCI risk groups over the follow-up period.
- timeFrame
- 5 Years
- measure
- To determine medication adherence in patients undergoing extended endocrine therapy.
- timeFrame
- 5 Years
- description
- Patients will be asked to complete a Medication Adherence Questionnaire during routine follow-up visits. Medication adherence scores over time will be evaluated in patients that are recommended for or elect to continue treatment to complete 10 years of adjuvant endocrine therapy.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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. * The primary tumor was HER2 negative or positive and node-negative or node-positive with 1-3 positive lymph nodes. * Subject has pre-treatment breast tumor tissue \[formalin fixed and paraffin embedded (FFPE)\] from a previous breast-conserving surgery, mastectomy or core needle biopsy available for testing by the Sponsor. Exclusion Criteria: * Patient has distant metastatic disease (M1). * Patient was diagnosed with metaplastic breast cancer, carcinosarcoma, sarcoma, neuroendocrine carcinoma, adenoid cystic carcinoma, or phyllodes tumor.
References
Publications (5)
- BACKGROUNDNoordhoek I, Treuner K, Putter H, Zhang Y, Wong J, Meershoek-Klein Kranenbarg E, Duijm-de Carpentier M, van de Velde CJH, Schnabel CA, Liefers GJ. Breast Cancer Index Predicts Extended Endocrine Benefit to Individualize Selection of Patients with HR+ Early-stage Breast Cancer for 10 Years of Endocrine Therapy. Clin Cancer Res. 2021 Jan 1;27(1):311-319. doi: 10.1158/1078-0432.CCR-20-2737. Epub 2020 Oct 27. PMID 33109739
- BACKGROUNDBartlett JMS, Sgroi DC, Treuner K, Zhang Y, Ahmed I, Piper T, Salunga R, Brachtel EF, Pirrie SJ, Schnabel CA, Rea DW. Breast Cancer Index and prediction of benefit from extended endocrine therapy in breast cancer patients treated in the Adjuvant Tamoxifen-To Offer More? (aTTom) trial. Ann Oncol. 2019 Nov 1;30(11):1776-1783. doi: 10.1093/annonc/mdz289. PMID 31504126
- BACKGROUNDZhang Y, Schnabel CA, Schroeder BE, Jerevall PL, Jankowitz RC, Fornander T, Stal O, Brufsky AM, Sgroi D, Erlander MG. Breast cancer index identifies early-stage estrogen receptor-positive breast cancer patients at risk for early- and late-distant recurrence. Clin Cancer Res. 2013 Aug 1;19(15):4196-205. doi: 10.1158/1078-0432.CCR-13-0804. Epub 2013 Jun 11. PMID 23757354
- BACKGROUNDSgroi DC, Sestak I, Cuzick J, Zhang Y, Schnabel CA, Schroeder B, Erlander MG, Dunbier A, Sidhu K, Lopez-Knowles E, Goss PE, Dowsett M. Prediction of late distant recurrence in patients with oestrogen-receptor-positive breast cancer: a prospective comparison of the breast-cancer index (BCI) assay, 21-gene recurrence score, and IHC4 in the TransATAC study population. Lancet Oncol. 2013 Oct;14(11):1067-1076. doi: 10.1016/S1470-2045(13)70387-5. Epub 2013 Sep 12. PMID 24035531
- BACKGROUNDSgroi DC, Carney E, Zarrella E, Steffel L, Binns SN, Finkelstein DM, Szymonifka J, Bhan AK, Shepherd LE, Zhang Y, Schnabel CA, Erlander MG, Ingle JN, Porter P, Muss HB, Pritchard KI, Tu D, Rimm DL, Goss PE. Prediction of late disease recurrence and extended adjuvant letrozole benefit by the HOXB13/IL17BR biomarker. J Natl Cancer Inst. 2013 Jul 17;105(14):1036-42. doi: 10.1093/jnci/djt146. Epub 2013 Jun 28.