Clinical trial · Interventional
Assessment of the Decision-making Impact of the Breast Cancer Index in Recommending Extended Adjuvant Endocrine Therapy for Patients With Early Stage ER-positive Breast Cancer
NCT02057029CI-TRIAL-00020473completedN/AClinicalTrials.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)
Investigators will examine the impact of the Breast Cancer Index (BCI) result on patients' anxiety / fear of recurrence and satisfaction with decisions regarding endocrine therapy.
Conditions
Conditions (2)
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 |
| Early Stage Estrogen Receptor (ER) Positive Breast Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCI Assay Results | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- BCI Assay Results
- description
- The Breast Cancer Index (BCI) is a novel gene expression-based prognostic predictor for ER positive cancers and is provided through a CLIA certified commercial laboratory. It is an RT-PCR assay that can be performed on formalin fixed paraffin embedded sections of archived tissues. Participants will work in concert with a physician to determine future treatment options based on BCI results.
- interventionNames
- Behavioral: BCI Assay Results
Primary outcomes (2)
- measure
- Patient Endocrine Therapy Questionnaires
- timeFrame
- baseline
- description
- These questionnaires are aimed at gathering the patient's perceived risk of recurrence, preference for continuing endocrine therapy after 5 years, concerns surrounding taking additional medication including concerns of cost, side effects, safety and benefit, as well as the level of comfort with the choice made both before and after the BCI test results are known.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: Each patient must meet all of the following criteria in order to be considered for enrollment: * Histologically confirmed ER positive, stage I-III breast cancer who have been treated with curative intent and completed at least four years of adjuvant endocrine therapy. * Life expectancy ≥ 5 years. * Must be able to provide informed consent. * Willing to consider continuation of endocrine therapy beyond 5 years. Exclusion Criteria: * A patient must not be enrolled if any contraindication exists for extended adjuvant endocrine therapy as identified by the treating oncologist.
References
Publications (1)
- DERIVEDSanft T, Aktas B, Schroeder B, Bossuyt V, DiGiovanna M, Abu-Khalaf M, Chung G, Silber A, Hofstatter E, Mougalian S, Epstein L, Hatzis C, Schnabel C, Pusztai L. Prospective assessment of the decision-making impact of the Breast Cancer Index in recommending extended adjuvant endocrine therapy for patients with early-stage ER-positive breast cancer. Breast Cancer Res Treat. 2015 Dec;154(3):533-41. doi: 10.1007/s10549-015-3631-9. Epub 2015 Nov 14. PMID 26578401