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

NCT02186470 | Completed DMC FDA Device

• 2 other identifiers: OSU-13282NCI-2014-01248
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

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

Keywords

Breast Cancer; Early Stage Breast Cancer; Hormone responsive breast cancer

Outcome Measures

Primary Outcomes (1)

• 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).

  4-6 weeks post-APBI

Secondary Outcomes (10)

• Acute surgical and radiotherapy toxicity as scored by the National Cancer Institute Common Toxicity Criteria (NCI CTCAE) version 4.0

  Up to 4 weeks post-surgery

• Late surgical and radiotherapy toxicity as scored by the NCI CTCAE version 4.0

  Up to 5 years

• Cosmetic outcome by the physician and patient

  At year 1

• Cosmetic outcome by the physician and patient

  At year 3

• In-breast recurrence

  Up to 5 years

Study Arms (1)

Treatment (image-guided intensity-modulated APBI)

EXPERIMENTAL

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; Radiation: intensity-modulated radiation therapy; Radiation: image-guided radiation therapy; Procedure: therapeutic conventional surgery

Interventions

accelerated partial breast irradiation RADIATION

Undergo image-guided intensity-modulated APBI

Also known as: APBI

Treatment (image-guided intensity-modulated APBI)

intensity-modulated radiation therapy RADIATION

Undergo image-guided intensity-modulated APBI

Also known as: IMRT

Treatment (image-guided intensity-modulated APBI)

image-guided radiation therapy RADIATION

Undergo image-guided intensity-modulated APBI

Treatment (image-guided intensity-modulated APBI)

therapeutic conventional surgery PROCEDURE

Lumpectomy

Treatment (image-guided intensity-modulated APBI)

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Carcinoma, Ductal, Breast; Breast Neoplasms

Interventions

Radiotherapy, Intensity-Modulated; Radiotherapy, Image-Guided

Condition Hierarchy (Ancestors)

Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Sasha Beyer, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 10, 2014
• Study Start: April 29, 2016
• Primary Completion: September 4, 2025
• Study Completion: September 4, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)