MRI-Based Preoperative Accelerated Partial Breast Irradiation

NCT02728076 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: PRO26847
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the feasibility to deliver accelerated partial breast irradiation (APBI) before a lumpectomy is performed. By administering the APBI before the lumpectomy, a smaller volume of breast tissue may be exposed to radiation. The APBI method used in this study is 3D (three dimensional) conformal external beam irradiation. 3D-conformal external beam irradiation uses an X-ray beam to deliver the radiation dose. Traditionally, CT imaging is used to plan treatment. In this study, an MRI will be used. Approximately five to eight weeks after completion of the APBI, the cancer will be surgically removed.

Conditions

Breast Cancer

Keywords

Breast Cancer; Accelerated Partial Breast Irradiation

Outcome Measures

Primary Outcomes (1)

• Postoperative Complications Following

  The number of subjects with one or more postoperative complications following preoperative accelerated partial breast irradiation within three months of surgery.

  3 Months

Secondary Outcomes (2)

• Re-excision of Tumor.

  5 Years

• Overall Survival

  5 Years

Study Arms (1)

Radiation Therapy followed by Lumpectomy

EXPERIMENTAL

Phase II-Preoperative MRI-BasedRadiation followed by Lumpectomy

Radiation: Phase II - Preoperative Radiation followed by Lumpectomy.

Interventions

Phase II - Preoperative Radiation followed by Lumpectomy. RADIATION

Selected patients will undergo a radiation planning procedure utilizing magnetic resonance imaging (MRI). Once this is completed, patients will receive five radiation treatments given every other day. After 28 days (four weeks), patients will have another MRI scan to compare tumor response to the radiation therapy. Following the MRI scan, roughly five to eight weeks later, patients will have a lumpectomy and possibly a sentinel lymph node biopsy. After surgery, tests will be performed on the tumor tissue to determine if genes expressed in the sample have changed. Following surgery, patients will receive chemotherapy and/or antihormone therapy at the discretion of the patient and physician.

Radiation Therapy followed by Lumpectomy

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically proven diagnosis of invasive breast cancer, clinically stage I-II.
• Female
• Age ≥40 years
• Estrogen receptor positive
• Patients with both her2 positive and her2 negative tumors are eligible
• Unifocal disease
• Invasive ductal carcinoma diagnosed by core needle biopsy
• Clinically node negative both by physical exam and by ultrasound. All enlarged or abnormal appearing lymph nodes must be biopsied.
• Zubrod performance status 0-2
• Study entry must be within 120 days from initial diagnosis of breast cancer.
• Complete blood count (CBC) /differential obtained within 14 days prior to study entry, with adequate bone marrow function defined as follows: Absolute neutrophil count ≥ 1,800 cells/mm\^3; Platelets ≥ 75,000 cells/mm\^3; Hemoglobin ≥8.0g/dl.
• Not pregnant or lactating; willing to use acceptable forms of contraception during radiation therapy.
• Prior breast augmentation, including breast implants, is allowed.
• Patients with a prior history of contralateral breast cancer will be considered eligible if they completed all treatment (including anti-endocrine therapy) more than five years prior to registration.
• Patients must not have a prior treatment of malignancy diagnosed or treated within the past five years, with the exception of non-melanomatous skin cancer, carcinoma in situ of the cervix and contralateral breast cancer.

You may not qualify if:

• American Joint Committee on Cancer (AJCC) clinical T3, N1-3, M1, stage IIB, stage III or stage IV breast cancer
• Prior invasive non-breast malignancy (exceptions include non-melanomatous skin cancer, carcinoma in situ of the cervix, or prior contralateral breast cancer as described in 3.1.11) unless disease free and off treatment for a minimum of five years prior to study entry.
• Multifocal breast cancer
• Modified Bloom-Richardson grade 3 disease
• Estrogen receptor negative disease
• Lymphovascular space invasion noted on biopsy
• Invasive lobular carcinoma
• Purely non-invasive breast cancer (i.e. ductal carcinoma in situ, lobular carcinoma in situ)
• Non-epithelial breast malignancies such as sarcoma or lymphoma
• Paget's disease of the nipple
• Male breast cancer
• Prior history of radiation therapy to the chest in the region of the ipsilateral breast that would result in overlap of radiation fields.
• Patients having received or having planned neoadjuvant chemotherapy or concurrent chemotherapy. A recommendation for adjuvant chemotherapy will not preclude eligibility. However, if a patient has an Oncotype score that would lead to a recommendation for systemic chemotherapy, and chemotherapy is planned to be given in the neoadjuvant setting, the patient would then be ineligible for enrollment.
• Patients who are unable to undergo magnetic resonance imaging (MRI). This could include patients with a severe allergy to gadolinium contrast or patients with renal function insufficient to receive contrast (GFR less than 30). Patients who have a minor allergy (for example, skin rash or hives) to gadolinium contrast may still be considered for enrollment. These patients would have to receive prophylactic prednisone and diphenhydramine per Medical College of Wisconsin Department of Radiology protocol. Such cases should be reviewed with the principal investigator and radiology co-chair prior to enrollment.
• History of connective tissue disorder, including lupus, dermatomyositis and scleroderma.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Adam Currey, MD
• Organization: Froedtert and the Medical college of Wisconsin

acurrey@mcw.edu

414-805-4462

Study Officials

• Adam Currey, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Associate Professor

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 5, 2016
• Study Start: July 29, 2016
• Primary Completion: September 16, 2021
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 19, 2026
• Results First Posted: January 26, 2023

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)