Clinical trial · Observational
NBRST: Prospective Neo-adjuvant REGISTRY Trial
Prospective Neo-adjuvant REGISTRY Trial Linking MammaPrint, Subtyping and Treatment Response: Neoadjuvant Breast Registry - Symphony Trial (NBRST) (Pronounced "in Breast")
- 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 scope of this registry study is to measure chemosensitivity as defined by pCR (primary endpoint), or endocrine sensitivity as defined by partial response (decrease in longest tumor diameter or residual cancer burden category 1 (RCB1), a primary endpoint for neo-adjuvant endocrine therapy and a secondary endpoint for neoadjuvant chemotherapy), metastasis-free survival and relapse-free survival(secondary endpoints) in molecular subgroups, determined by the established MammaPrint, BluePrint, Targetprint and Theraprint profiles in addition to possible novel expression profiles.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BluePrint 80 gene expression profile | Other | — | UNRESOLVED |
| MammaPrint 70-gene expression profile | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- MammaPrint, BluePrint, neo-adj CT or HT
- description
- All patients receive the MammaPrint and BluePrint gene expression profile. Treatment at the discretion of the physician while adhering to NCCN guidelines.
- interventionNames
- Other: MammaPrint 70-gene expression profile
- Other: BluePrint 80 gene expression profile
Primary outcomes (2)
- measure
- Chemosensitivity as defined by pCR
- timeFrame
- Up to 6 months
- description
- For neo-adjuvant chemotherapy patients the primary endpoint is pathological complete response (pCR) which is defined as the absence of invasive carcinoma in both the breast and axilla at microscopic examination of the resection specimen, regardless of the presence of carcinoma in situ. The response rate and corresponding confidence intervals will be presented as a proportion of all patients enrolled. Comparison of response rates between different molecular subgroups will be conducted using Pearson Chi-square test.
- measure
- Endocrine sensitivity as defined by partial response (decrease in longest tumor diameter or residual cancer burden category 1 (RCB1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Women with histologically proven breast cancer, who have started or are scheduled to start neo-adjuvant chemotherapy therapy or neo-adjuvant hormone therapy, after successful MammaPrint assay * Age 18-90 * Written informed consent Exclusion Criteria: * Patients who have had excisional biopsy or axillary dissection Patients with confirmed distant metastatic disease * Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria * Patients who have had any prior chemotherapy, radiotherapy, or endocrine therapy for the treatment of breast cancer * Any serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
References
Publications (2)
- DERIVEDWhitworth PW, Beitsch PD, Murray MK, Richards PD, Mislowsky A, Dul CL, Pellicane JV, Baron PL, Rahman RL, Lee LA, Dupree BB, Kelemen PR, Ashikari AY, Budway RJ, Lopez-Penalver C, Dooley W, Wang S, Dauer P, Menicucci AR, Yoder EB, Finn C, Blumencranz LE, Audeh W. Genomic Classification of HER2-Positive Patients With 80-Gene and 70-Gene Signatures Identifies Diversity in Clinical Outcomes With HER2-Targeted Neoadjuvant Therapy. JCO Precis Oncol. 2022 Sep;6:e2200197. doi: 10.1200/PO.22.00197. PMID 36108259
- DERIVEDWhitworth PW, Beitsch PD, Pellicane JV, Baron PL, Lee LA, Dul CL, Murray MK, Gittleman MA, Budway RJ, Rahman RL, Kelemen PR, Dooley WC, Rock DT, Cowan KH, Lesnikoski BA, Barone JL, Ashikari AY, Dupree BB, Wang S, Menicucci AR, Yoder EB, Finn C, Corcoran K, Blumencranz LE, Audeh W; NBRST Investigators Group. Distinct Neoadjuvant Chemotherapy Response and 5-Year Outcome in Patients With Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Tumors That Reclassify as Basal-Type by the 80-Gene Signature. JCO Precis Oncol. 2022 Apr;6(1):e2100463. doi: 10.1200/PO.21.00463. PMID 35476550