Breast Cancer Clinical Trial
Official title:
Molecular Predictors of Loco-Regional Recurrence in Node Positive Breast Cancer
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may
help doctors identify and learn more about biomarkers related to cancer. It may also help
doctors predict whether cancer will come back after treatment.
PURPOSE: This research trial is studying genes that may predict local recurrence in samples
from patients with breast cancer. treated on NSABP-B-28
OBJECTIVES:
- To evaluate the association between the 21-gene Recurrence Score and risk of
local-regional recurrence (LRR) in node-positive, estrogen receptor- (ER) positive (+)
patients treated with cyclophosphamide and doxorubicin hydrochloride (AC) with or
without paclitaxel in the NSABP-B-28 trial.
- To evaluate the potential for combining the 21-gene Recurrence Score (RS) with
traditional clinico-pathologic factors in order to derive an improved algorithm for
prediction of LRR risk and in order to identify subgroups of ER-positive patients with
1-3 or 4 or more positive nodes who do/do not need post mastectomy chest wall
radiotherapy (XRT) or regional nodal XRT (irrespective of surgical procedure).
- To evaluate whether the 21-gene RS predicts benefit from adding paclitaxel to AC
chemotherapy in reducing risk of LRR, and improving disease-free survival (DFS) and
overall survival (OS) in node-positive, ER-positive patients from NSABP-B-28.
OUTLINE: RNA extracted from paraffin-embedded tissue samples are analyzed for gene
expression profile by Ribogreen assay and RT-PCR. Results are then compared and analyzed
with each patient clinical-pathologic factors, including tumor size, patient age, number of
positive nodes (1-3, 4+), tumor grade, and surgery type (mastectomy or lumpectomy).
;
Observational Model: Case Control, Time Perspective: Retrospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
| Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
| Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
| Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
| Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
| Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
| Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
| Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
| Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
| Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
| Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
| Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
| Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
| Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
| Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
| Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
| Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
| Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A |