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

Primary Purpose

Estrogen Receptor-positive Breast Cancer, Invasive Ductal Breast Carcinoma, Invasive Ductal Breast Carcinoma With Predominant Intraductal Component

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
accelerated partial breast irradiation
intensity-modulated radiation therapy
image-guided radiation therapy
therapeutic conventional surgery
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Estrogen Receptor-positive Breast Cancer focused on measuring Breast Cancer, Early Stage Breast Cancer, Hormone responsive breast cancer

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Ohio State University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (image-guided intensity-modulated APBI)

Arm Description

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.

Outcomes

Primary Outcome Measures

The primary endpoint will be the reproducibility of the MRI directed preoperative APBI treatment method
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
Late surgical and radiotherapy toxicity as scored by the NCI CTCAE version 4.0
Cosmetic outcome by the physician and patient
Cosmetic outcome by the physician and patient
In-breast recurrence
Regional recurrence
Distant metastases
Disease free survival
Overall survival
Exploratory evaluation of patient breast cancer tissue and serum for CSCs, biomarkers and miRNAs
Correlative analyses

Full Information

First Posted
July 7, 2014
Last Updated
April 3, 2023
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02186470
Brief Title
Intensity Modulated Accelerated Partial Breast Irradiation Before Surgery in Treating Older Patients With Hormone Responsive Stage 0-I Breast Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 29, 2016 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Breast Cancer, Early Stage Breast Cancer, Hormone responsive breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (image-guided intensity-modulated APBI)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
accelerated partial breast irradiation
Other Intervention Name(s)
APBI
Intervention Description
Undergo image-guided intensity-modulated APBI
Intervention Type
Radiation
Intervention Name(s)
intensity-modulated radiation therapy
Other Intervention Name(s)
IMRT
Intervention Description
Undergo image-guided intensity-modulated APBI
Intervention Type
Radiation
Intervention Name(s)
image-guided radiation therapy
Intervention Description
Undergo image-guided intensity-modulated APBI
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Intervention Description
Lumpectomy
Primary Outcome Measure Information:
Title
The primary endpoint will be the reproducibility of the MRI directed preoperative APBI treatment method
Description
Acceptability of the definition of treatment targets by MRI, radiation virtual IMRT plans and completion of treatment (APBI and surgery).
Time Frame
4-6 weeks post-APBI
Secondary Outcome Measure Information:
Title
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
Title
Late surgical and radiotherapy toxicity as scored by the NCI CTCAE version 4.0
Time Frame
Up to 5 years
Title
Cosmetic outcome by the physician and patient
Time Frame
At year 1
Title
Cosmetic outcome by the physician and patient
Time Frame
At year 3
Title
In-breast recurrence
Time Frame
Up to 5 years
Title
Regional recurrence
Time Frame
Up to 5 years
Title
Distant metastases
Time Frame
Up to 5 years
Title
Disease free survival
Time Frame
Up to 5 years
Title
Overall survival
Time Frame
Up to 5 years
Title
Exploratory evaluation of patient breast cancer tissue and serum for CSCs, biomarkers and miRNAs
Description
Correlative analyses
Time Frame
Up to 4 weeks post-surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sasha Beyer, MD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline

Learn more about this trial

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

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