Breast Cancer Clinical Trial
Official title:
Electronic Xoft Intersociety Brachytherapy Trial
PRINCIPAL INVESTIGATORS
- Rakesh Patel, MD- Radiation Oncologist
- Peter Beitsch, MD- Breast Surgeon
REGISTRY DESIGN
- Multicenter, non-randomized, post market registry of intracavitary accelerated partial
breast irradiation in appropriately selected patients.
SAMPLE SIZE AND SITES:
- Approximately 400 patients may be enrolled.
- Up to 100 qualified U.S. sites may participate in this registry.
ENDPOINTS:
1. PRIMARY ENDPOINTS
- Subcutaneous Toxicities - The incidence of signs and symptoms of subcutaneous
toxicities will be recorded at the following follow-up visits; at six (6) month,
one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year.
- Skin Toxicities - Specific toxicities that can result from radiation therapy will
be recorded at each follow-up visit. The Common Terminology Criteria for Adverse
Events will be used and to be recorded at each follow-up visits; at one (1) month,
six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five
(5) year.
- Cosmetic Outcome - Cosmetic outcome will be recorded at the following follow-up
visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3)
year, four (4) year, and five (5) year. Cosmetic outcome will be assessed and
graded in two ways:
- Patient Quality of Life Questionnaire - A Quality of Life Questionnaire (QOL) will
be completed at the following visits; at one (1) month, six (6) month, one (1)
year, two (2) year, three (3) year, four (4) year, and five (5) year.
2. SECONDARY ENDPOINTS
- Local-regional Breast Failure - The secondary efficacy endpoint is ipsilateral
breast failure at five (5) years.
This includes:
- Ipsilateral recurrence within the initially treated volume. (Within the tumor bed)
- Ipsilateral recurrence of cancer outside of the initially treated volume.
(Elsewhere Failure)
- Axillary nodal recurrence
- Survival - to be recorded at each follow-up visit
- Overall Survival
- Disease Free Survival
- Device Performance - to be recorded during the balloon applicator placement
and during the course of the radiation treatments:
- Ability to deliver treatment
- Axxent System / Balloon Applicator performance
3. TREATMENT DEVICE
The device to be used is the electronic brachytherapy system for the treatment of early
stage breast cancer with intracavitary accelerated partial breast irradiation. The device
manufacturer is Xoft, Incorporated. All Xoft technology cleared by the FDA for the treatment
of early stage breast cancer can be used in this post market data collection registry.
OVERSIGHT COMMITTEE
Representatives from American Brachytherapy Society (ABS), American Society of Breast
Surgeons (ASBS), and American College of Radiation Oncology (ACRO)will oversee study
management.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
|
||
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 |