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

This study is currently recruiting participants.
Verified September 2017 by Julia White, Ohio State University Comprehensive Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02186470
First Posted: July 10, 2014
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Julia White, Ohio State University Comprehensive Cancer Center
  Purpose
This pilot clinical trial studies intensity-modulated accelerated partial breast irradiation (APBI) before surgery in treating older patients with estrogen receptor positive or progesterone receptor positive stage 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
Estrogen Receptor-positive Breast Cancer Invasive Ductal Breast Carcinoma Invasive Ductal Breast Carcinoma With Predominant Intraductal Component 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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 Julia White, Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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).


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 ]
  • Late surgical and radiotherapy toxicity as scored by the NCI CTCAE version 4.0 [ Time Frame: Up to 5 years ]
  • Cosmetic outcome by the physician and patient [ Time Frame: At year 1 ]
  • Cosmetic outcome by the physician and patient [ Time Frame: At year 3 ]
  • In-breast recurrence [ Time Frame: Up to 5 years ]
  • Regional recurrence [ Time Frame: Up to 5 years ]
  • Distant metastases [ Time Frame: Up to 5 years ]
  • Disease free survival [ Time Frame: Up to 5 years ]
  • Overall survival [ Time Frame: 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


Estimated Enrollment: 30
Actual Study Start Date: June 2015
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (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 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.
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
Lumpectomy

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:

  1. To determine the acute and late surgical and radiation toxicity of preoperative APBI delivered with IMRT in the prone position.
  2. To document the cosmetic appearance of the breast when treated with preoperative APBI IMRT in the prone position.
  3. Establish the percentage of patients that can meet dosimetric goals and normal tissue constraints if treated with preoperative APBI IMRT in the prone position.
  4. 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes 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.
  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186470


Contacts
Contact: Ohio State University Comprehensive Cancer Center 1-800-293-5066 OSUCCCClinicaltrials@osumc.edu
Contact: Sohyun McElroy, Ph.D. 614.685.7050 Sohyun.McElroy@osumc.edu

Locations
United States, Ohio
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Julia R. White, MD    614-688-7367    Julia.White@osumc.edu   
Contact: Sohyun L McElroy, Ph.D.    614.685/7050    Sohyun.McElroy@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:
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 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: July 7, 2014
First Posted: July 10, 2014
Last Update Posted: September 20, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Julia White, Ohio State University Comprehensive Cancer Center:
Breast Cancer
Early Stage Breast Cancer
Hormone responsive breast cancer

Additional relevant MeSH terms:
Carcinoma
Breast Neoplasms
Carcinoma, Ductal, Breast
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Carcinoma, Ductal
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs