Breast Cancer Clinical Trial
Official title:
Genetic Counseling for Newly Diagnosed Breast Cancer Patients
Verified date | January 2013 |
Source | Georgetown University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
RATIONALE: Genetics education and counseling may help patients make treatment decisions. It
is not yet known how genetic counseling or usual care influence patient treatment decisions
for breast cancer.
PURPOSE: This randomized clinical trial is studying how well genetic counseling works
compared to usual care in helping patients with newly diagnosed ductal carcinoma in situ,
stage I, stage II, or stage IIIA breast cancer make treatment decisions.
Status | Completed |
Enrollment | 331 |
Est. completion date | July 2011 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Newly diagnosed breast cancer, meeting 1 of the following criteria: - Stage 0 disease (ductal carcinoma in situ only) - Stage I-IIIA disease - Must meet 1 of the following criteria: - Diagnosis before 50 years of age - Diagnosis after 50 years of age AND has 1 of the following: - First or second degree relative diagnosed with breast cancer before 50 years of age - First or second degree relative diagnosed with ovarian cancer at any age - First or second degree relative diagnosed with male breast cancer at any age - Must not have initiated definitive treatment for breast cancer - No bilateral, metastatic, or inflammatory breast cancer - No prior BRCA1/2 counseling or testing - No prior diagnosis of metastatic cancer of any type - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Sex - Female Menopausal status - Not specified Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified PRIOR CONCURRENT THERAPY: Surgery - No prior bilateral mastectomy for breast cancer Other - No concurrent treatment for cancer |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Hackensack University Medical Center Cancer Center | Hackensack | New Jersey |
United States | Mount Sinai School of Medicine | New York | New York |
United States | Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Georgetown University | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Definitive surgery choice as measured by self-reported and medical record verification at 6 months after randomization | 1, 6, and 12 months | No | |
Primary | Quality of life as measured by functional assessment of cancer therapy for breast cancer (FACT-B) at 1, 6, and 12 months after randomization | 1, 6, and 12 months | No | |
Primary | Distress as measured by Impact of Events Scale Brief Symptom Inventory at 1, 6, and 12 months after randomization | 1, 6, and 12 months | No | |
Primary | Knowledge as assessed by Genetic Testing Knowledge Measure at 1 month after randomization | 1 month | No | |
Primary | Decision outcomes as assessed by Decisional Conflict Scale Satisfaction with Decision Scale at 1 and 6 months after randomization | 1 and 6 months | No | |
Secondary | Cost effectiveness as measured by quality adjusted life years saved at 12 months after randomization | 12 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
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
|
||
Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
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 |
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 | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 |