Breast Cancer Clinical Trial
— CK-SAPBIOfficial title:
A Pilot Study of Stereotactic Accelerated Partial Breast Irradiation (SAPBI) for Post-Menopausal Women (>50 y/o) With Ductal Carcinoma in Situ (DCIS) or Early Stage Breast Cancer
Verified date | June 2016 |
Source | Georgetown University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will prospectively evaluate the technical feasibility, acute toxicity, late effects and oncologic outcomes of CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI) in early stage breast cancer. It will evaluate quality of life (QOL) issues as they relate to treatment-related side effects and cosmetic results.
Status | Terminated |
Enrollment | 2 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 50 Years to 99 Years |
Eligibility |
Inclusion Criteria: - -Newly diagnosed Stage 0 or I breast cancer. - On histological examination, the tumor must be DCIS or invasive non-lobular carcinoma of the breast - Surgical treatment of the breast must have been wide excision, lumpectomy or partial mastectomy - Age 50 years or greater - ER positive: (=1% of breast tumor cells express ER in their nuclei) - PR (progesterone receptor) positive: (= 1% of breast tumor cells express PR in their nuclei) - Her2 negative (IHC 0-1+; for IHC 2+, FISH (fluorescence in situ hybridization) must be non-amplified) - Subjects with invasive tumors should undergo axillary sentinel lymph node evaluation or axillary lymph node dissection. - Negative inked surgical margins of excision or re-excision, clear of invasive tumor (no cells on ink) and DCIS by at least 1 mm - Negative post-excision or post-reexcision mammography if cancer presented with malignancy-associated microcalcifications with no remaining suspicious calcifications in the breast before radiotherapy. Alternatively, a specimen radiograph can be obtained showing all the suspicious calcifications. - No involved axillary lymph nodes, N0(i+) allowed - Enrollment and the plan to initiate of CyberKnife therapy within 12 weeks of the last breast cancer surgery. - Target lumpectomy cavity/whole breast reference volume must be <30% based on treatment planning CT - Signed study-specific informed consent form Exclusion Criteria: - -Patients with invasive lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma. - Patients with tumors greater than 2 cm - Patients with surgical margins which cannot be microscopically assessed or not cleared by at least 2mm at pathological evaluation. - Patients with multicentric carcinoma or with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy. Breast MRI will be recommended to exclude multicentric disease and additional suspicious areas will require biopsy to exclude malignancy. - Patient with lymphovascular space invasion (LVSI). - Patients with involved axillary nodes. - Patients with collagen vascular diseases. - Patient with known deleterious BRCA1/2 mutations or known mutations in other high penetrance genes (TP53, STK11, PTEN-phosphatase and tensin homolog, CDH1) - Patients with prior ipsilateral breast irradiation. - Patients with prior ipsilateral thoracic irradiation. - Patients with Paget's disease of the nipple. - Patients with diffuse suspicious microcalcifications. - Patients with suspicious microcalcifications remaining on the post-excision mammogram. - Patients receiving (neo)adjuvant systemic therapy other than hormonal therapy - Patients with oncoplastic reconstruction and absence of surgical clips |
Country | Name | City | State |
---|---|---|---|
United States | Georgetown University Hospital | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Georgetown University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Primary Endpoint for This Study is the Percentage of Enrolled Subjects in Whom CyberKnife SAPBI PBI is Technically Feasible to Deliver and Complete Treatment | Only one of two patients were able to undergo CyberKnife SAPBI. We are measuring the percentage of enrolled subjects in whom CyberKnife SAPBI PBI is technically feasible to deliver and complete treatment | Enrollment to 24 months | |
Primary | Feasibility | How many patients were able to undergo CK SAPBI | 2 years | |
Secondary | Ipsilateral Breast Recurrence | No patients have recurred to date. | 1 month post radiation treatment through 5 years post 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
|
||
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 |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
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 |