Intensity Modulated Accelerated Partial Breast Irradiation Before Surgery in Treating Older Patients With Hormone Responsive Stage 0-I Breast Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Ohio State University Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Julia White, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT02186470
First received: July 7, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
  Purpose

This clinical trial studies intensity-modulated accelerated partial breast irradiation (APBI) before surgery in treating older patients with estrogen receptor positive or negative and progesterone receptor positive stage 0-I breast cancer. APBI is a specialized type of radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.


Condition Intervention
Ductal Breast Carcinoma in Situ
Estrogen Receptor-negative Breast Cancer
Estrogen Receptor-positive Breast Cancer
Invasive Ductal Breast Carcinoma
Invasive Ductal Breast Carcinoma With Predominant Intraductal Component
Lobular Breast Carcinoma in Situ
Medullary Ductal Breast Carcinoma With Lymphocytic Infiltrate
Mucinous Ductal Breast Carcinoma
Papillary Ductal Breast Carcinoma
Progesterone Receptor-positive Breast Cancer
Stage IA Breast Cancer
Stage IB Breast Cancer
Tubular Ductal Breast Carcinoma
Radiation: accelerated partial breast irradiation
Radiation: intensity-modulated radiation therapy
Radiation: image-guided radiation therapy
Procedure: therapeutic conventional surgery
Other: questionnaire administration
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Reproducibility of the MRI directed pre-operative APBI treatment method based on meeting 3 criteria: acceptability of the definition of treatment targets by MRI, radiation virtual IMRT plans and completion of treatment (APBI and surgery) [ Time Frame: 4 weeks post-APBI ] [ Designated as safety issue: No ]
    The movement of the center of mass for each organ will be determined. Their means and the standard deviations will be calculated. Histogram will also be generated. The volumetric dosimetric parameters will be compared with historic data and will be used to search any correlation with follow-up outcome data.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Late surgical and radiotherapy toxicity as scored by the NCI CTCAE version 4.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
  • Cosmetic outcome by the physician and patient [ Time Frame: At year 1 ] [ Designated as safety issue: No ]
  • Cosmetic outcome by the physician and patient [ Time Frame: At year 3 ] [ Designated as safety issue: No ]
  • In-breast recurrence [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Regional recurrence [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Distant metastases [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Disease free survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2014
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (image-guided intensity-modulated APBI)
Patients undergo image-guided intensity-modulated APBI BID for 5 days over a period of 5-10 days for a total of 10 fractions. Within 4-6 weeks post-APBI, patients undergo lumpectomy.
Radiation: accelerated partial breast irradiation
Undergo image-guided intensity-modulated APBI
Other Name: APBI
Radiation: intensity-modulated radiation therapy
Undergo image-guided intensity-modulated APBI
Other Name: IMRT
Radiation: image-guided radiation therapy
Undergo image-guided intensity-modulated APBI
Procedure: therapeutic conventional surgery
Undergo lumpectomy
Other: questionnaire administration
Ancillary studies
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. Establish the feasibility for preoperative APBI delivered with intensity-modulated radiation therapy (IMRT) in the prone position using daily computed tomography (CT) guidance for stage 0-I breast cancer patients who are intended to undergo a lumpectomy for breast conserving therapy.

SECONDARY OBJECTIVES:

I. To determine the acute and late surgical and radiation toxicity of preoperative APBI delivered with IMRT in the prone position.

II. To document the cosmetic appearance of the breast when treated with preoperative APBI IMRT in the prone position.

III. Establish the percentage of patients that can meet dosimetric goals and normal tissue constraints if treated with preoperative APBI IMRT in the prone position.

OUTLINE:

Patients undergo image-guided intensity-modulated APBI twice daily (BID) for 5 days over a period of 5-10 days for a total of 10 fractions. Within 4-6 weeks post-APBI, patients undergo lumpectomy.

After completion of treatment, patients are followed up at 4 weeks and then at 1, 2, and 3 years.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  • Core biopsy demonstrating breast cancer and receptors that are estrogen receptor positive or negative (ER +/-) PR positive
  • Core tissue must have human epidermal growth factor receptor 2 (HER 2) testing
  • 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 mammogram/magnetic resonance imaging (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:

  • 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 pathologic 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 ductal carcinoma in situ [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 radiation therapy (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02186470

Contacts
Contact: Ohio State University Comprehensive Cancer Center 1-800-293-5066 Jamesline@osumc.edu
Contact: Julia White, MD 614-688-7367 Julia.White@osumc.edu

Locations
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Not yet recruiting
Columbus, Ohio, United States, 43210
Contact: Julia R. White    614-688-7367    Julia.White@osumc.edu   
Principal Investigator: Julia R. White, MD         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Julia White, MD Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Julia White, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02186470     History of Changes
Other Study ID Numbers: OSU-13282, NCI-2014-01248
Study First Received: July 7, 2014
Last Updated: July 7, 2014
Health Authority: United States: Federal Government

Keywords provided by Ohio State University Comprehensive Cancer Center:
Breast Cancer
Early Stage Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma, Ductal, Breast
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma
Carcinoma, Lobular
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma, Ductal
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on September 16, 2014