Breast Cancer Clinical Trial
— GCC 0919Official title:
Preoperative Accelerated Partial Breast Irradiation (APBI) for Women With Stage I and Select IIA Breast Cancer
Verified date | September 2019 |
Source | University of Maryland, Baltimore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to examine the feasibility to deliver PBI before the lumpectomy
is performed. By administering the PBI before the lumpectomy, a smaller volume of breast
tissue may be exposed to radiation. The PBI method used in this study is 3D (three
dimensional) conformal external beam irradiation. 3D-conformal external beam irradiation uses
an x-ray beam to deliver the radiation dose. Approximately 3 weeks after completion of the
PBI, the cancer will be surgically removed.
This study will learn about the good and bad effects of 3D-conformal external beam
irradiation PBI when given before the cancer has been removed by lumpectomy. The study will
also learn about the feelings women have about how their breast looks after PBI and surgery.
Status | Completed |
Enrollment | 32 |
Est. completion date | November 12, 2018 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Women who satisfy all of the following conditions are the only patients who will be eligible for this study: 1. Patient must have invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies. 2. AJCC Stage I or IIA (T1N0 or T2N0) histologically confirmed invasive carcinoma of the breast with a primary lesion (less than/equal to 3 cm)by MRI or ultrasound 3. Clinically negative axillary lymph nodes. Standard routine imaging assessment of the axilla is performed by either ultrasound or MRI. If lymph nodes are suspicious, a biopsy is required. An involved axilla is purposely excluded. 4. Unifocal breast cancer (single focus which can be encompassed by one lumpectomy). 5. Patients must have an estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth receptor 2 (H2N) analyses performed on the primary tumor prior to enrollment. 6. Based on pre-treatment planning CT scan, the ratio of the PTV to the reference breast volume should not exceed 25%. 7. Patients must be greater than/equal to 18 years of age. 8. Pretreatment evaluations required for eligibility include: bilateral mammogram, histologic confirmation of malignancy, and physical exam. 9. Signed study-specific informed consent form prior to study entry. 10. Women of childbearing potential must use an effective contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills. Exclusion Criteria: Men are not eligible for this study. Women with one or more of the following conditions also are ineligible for this study: 1. Evidence of suspicious microcalcifications which are separate from the known lesion unless pathologically confirmed to be benign. 2. Patient with distant metastases. 3. Patients with invasive lobular or extensive in-situ lobular carcinoma or pure ductal carcinoma in-situ or non-epithelial breast malignancies such as sarcoma or lymphoma. 4. Patients with proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm) or with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy. 5. Patient whose tumor is not visible on radiation treatment planning CT scan 6. Palpable or radiographically suspicious ipsilateral axillary, supraclavicular, infraclavicular or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor. 7. Prior hormonal or non-hormonal therapy or radiation therapy for the current breast cancer. 8. Patients with Paget's disease of the nipple. 9. Patients with skin involvement, regardless of tumor size. 10. Patients with a breast technically unsatisfactory for radiation therapy. 11. Patients with collagenous diseases, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis. 12. Patients with co-existing medical conditions with life expectancy less than 2 years. 13. Patients with psychiatric or addictive disorders that would preclude obtaining informed consent. 14. Patients who are pregnant or lactating due to potential exposure of the fetus to RT and unknown effects of RT to lactating females. |
Country | Name | City | State |
---|---|---|---|
United States | Ummc Msgcc | Baltimore | Maryland |
United States | Central Maryland Oncology Center | Columbia | Maryland |
United States | Baltimore Washington Medical Center | Glen Burnie | Maryland |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, Baltimore |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary endpoint of this study is determination of the reproducibility of delivering preoperative APBI in Stage I and Stage IIA breast cancers. | This will be done by using 3D-CRT by evaluating the prescription isodose curves, dose inhomogeneity, and coverage of the volume as defined by CT treatment planning to delineate the target volume. | 5 years | |
Secondary | Evaluation of pathologic response, cosmetic results, of lumpectomy wound healing and the overall complication rate, ipsilateral breast recurrence rate | These endpoints will be accomplished by utilizing the pathology report; the cosmesis will be judged by the patient, radiation oncologist and/or surgeon, at stated follow-up intervals; and the breast recurrence rate will be evaluated by disease status at routine patient follow-up appointments, including yearly mammography. | 5 years |
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
|
||
Recruiting |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
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 |
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 |