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

NCT ID: NCT02186470

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-29
• Study Completion Date: 2025-09-04

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:

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

accelerated partial breast irradiation

Intervention Type: RADIATION

Undergo image-guided intensity-modulated APBI

intensity-modulated radiation therapy

Intervention Type: RADIATION

Undergo image-guided intensity-modulated APBI

image-guided radiation therapy

Intervention Type: RADIATION

Undergo image-guided intensity-modulated APBI

therapeutic conventional surgery

Intervention Type: PROCEDURE

Lumpectomy

Interventions

accelerated partial breast irradiation

Undergo image-guided intensity-modulated APBI

Intervention Type: RADIATION

intensity-modulated radiation therapy

Undergo image-guided intensity-modulated APBI

Intervention Type: RADIATION

image-guided radiation therapy

Undergo image-guided intensity-modulated APBI

Intervention Type: RADIATION

therapeutic conventional surgery

Lumpectomy

Intervention Type: PROCEDURE

Other Intervention Names

APBI; IMRT

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Sasha Beyer

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sasha Beyer, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form: Cohort 1 Informed Consent

View Document

Document Type: Informed Consent Form: Cohort 2 Informed Consent

View Document

Related Links

http://cancer.osu.edu

The Jamesline

Other Identifiers

NCI-2014-01248

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-13282

Identifier Type: -

Identifier Source: org_study_id