- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02186470
Intensity Modulated Accelerated Partial Breast Irradiation Before Surgery in Treating Older Patients With Hormone Responsive Stage 0-I Breast Cancer
Feasibility of Assessing Radiation Response With MRI/CT Directed Preoperative Accelerated Partial Breast Irradiation in the Prone Position for Hormone Responsive Early Stage Breast Cancer
Study Overview
Status
Conditions
- Stage IA Breast Cancer
- Stage IB Breast Cancer
- Estrogen Receptor-positive Breast Cancer
- Progesterone Receptor-positive Breast Cancer
- Invasive Ductal Breast Carcinoma
- Medullary Ductal Breast Carcinoma With Lymphocytic Infiltrate
- Mucinous Ductal Breast Carcinoma
- Papillary Ductal Breast Carcinoma
- Tubular Ductal Breast Carcinoma
- Invasive Ductal Breast Carcinoma With Predominant Intraductal Component
Detailed Description
PRIMARY OBJECTIVES:
Establish the feasibility for preoperative APBI delivered with IMRT in the prone position using daily CT guidance for Stage I breast cancer patients who are intended to undergo a lumpectomy for breast conserving therapy.
SECONDARY OBJECTIVES:
- To determine the acute and late surgical and radiation toxicity of preoperative APBI delivered with IMRT in the prone position.
- To document the cosmetic appearance of the breast when treated with preoperative APBI IMRT in the prone position.
- Establish the percentage of patients that can meet dosimetric goals and normal tissue constraints if treated with preoperative APBI IMRT in the prone position.
- Evaluate molecular changes in breast cancer and/or stroma before and after preoperative APBI
OUTLINE:
Patients undergo image-guided intensity-modulated APBI twice daily (BID) in the prone position over a period of 5-10 days for a total of 10 treatment. Within 4-6 weeks post-APBI, patients undergo lumpectomy.
After completion of treatment, patients are followed up at 4 weeks and then every 6 months for 5 years.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sohyun McElroy, Ph.D.
- Phone Number: 614.685.7050
- Email: Sohyun.McElroy@osumc.edu
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Ohio State University Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines.
- Patient must be ≥ 50 years
- Core biopsy demonstrating breast cancer and receptors that are ER or PR positive.
- Core tissue must have HER 2 negative followed by current ASCO/CAP guidelines.
- The patient must have clinical node negative, stage I breast cancer.
- The surgical treatment must be intended to be a lumpectomy
- The biopsy site must have been demarcated by a clip(s)
- Gross disease must be unifocal on Mammo/ MRI imaging
- Patients must have estrogen receptor (ER) and progesterone receptor (PR) analysis performed on core biopsy
- Patient must be able to tolerate lying in the prone position with arms extended forward.
- Must be able to tolerate MRI scan with contrast
- At the time of enrollment, patients must have had bilateral mammograms within 6 months.
- Patients must be willing to undergo breast cancer surgery minimally 4, maximally 6 weeks post APBI.
- Patients with a history of non-breast malignancies are eligible if they have been disease free for 5 or more years prior to enrollment and are deemed by their physicians to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
Exclusion Criteria:
- Age < 50 years
- Hormone unresponsive breast cancer
- T-2 ( > 3.0 cm), T-3, Stage III, or Stage IV breast cancer.
- N-1, N-2, or N-3 clinical axillary nodes
- Mastectomy intended
- Unwilling to undergo anti-endocrine therapy
- Suspicious microcalcification, densities, or palpable abnormalities ( in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
- Non-epithelial breast malignancies such as sarcoma or lymphoma.
- Paget's disease of the nipple
- Proven multicentric carcinoma (invasive or DCIS) in more than one quadrant or separated by > 4 centimeters.
- Any prior treatment with radiation therapy, chemotherapy, biotherapy, or hormone therapy for the currently diagnosed breast cancer prior to study enrollment.
- Prior breast or thoracic RT for any condition.
- Psychiatric of addictive disorders or other condition that in the opinion of the investigator would preclude the patient from meeting the study requirements.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (image-guided intensity-modulated APBI)
Patients undergo image-guided intensity-modulated APBI twice daily (BID) in the prone position over a period of 5-10 days for a total of 10 treatment.
Within 4-6 weeks post-APBI, patients undergo lumpectomy.
|
Undergo image-guided intensity-modulated APBI
Other Names:
Undergo image-guided intensity-modulated APBI
Other Names:
Undergo image-guided intensity-modulated APBI
Lumpectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The primary endpoint will be the reproducibility of the MRI directed preoperative APBI treatment method
Time Frame: 4-6 weeks post-APBI
|
Acceptability of the definition of treatment targets by MRI, radiation virtual IMRT plans and completion of treatment (APBI and surgery).
|
4-6 weeks post-APBI
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Acute surgical and radiotherapy toxicity as scored by the National Cancer Institute Common Toxicity Criteria (NCI CTCAE) version 4.0
Time Frame: Up to 4 weeks post-surgery
|
Up to 4 weeks post-surgery
|
|
Late surgical and radiotherapy toxicity as scored by the NCI CTCAE version 4.0
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Cosmetic outcome by the physician and patient
Time Frame: At year 1
|
At year 1
|
|
Cosmetic outcome by the physician and patient
Time Frame: At year 3
|
At year 3
|
|
In-breast recurrence
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Regional recurrence
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Distant metastases
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Disease free survival
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Exploratory evaluation of patient breast cancer tissue and serum for CSCs, biomarkers and miRNAs
Time Frame: Up to 4 weeks post-surgery
|
Correlative analyses
|
Up to 4 weeks post-surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sasha Beyer, MD, Ohio State University Comprehensive Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSU-13282
- NCI-2014-01248 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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