Preoperative Accelerated Partial Breast Irradiation (APBI) for Women With Stage I and Select IIA Breast Cancer

NCT01014715 | Completed DMC

• 2 other identifiers: HP-00042098GCC 0919
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to examine the feasibility to deliver PBI before the lumpectomy is performed. By administering the PBI before the lumpectomy, a smaller volume of breast tissue may be exposed to radiation. The PBI 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. Approximately 3 weeks after completion of the PBI, the cancer will be surgically removed. This study will learn about the good and bad effects of 3D-conformal external beam irradiation PBI when given before the cancer has been removed by lumpectomy. The study will also learn about the feelings women have about how their breast looks after PBI and surgery.

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of this study is determination of the reproducibility of delivering preoperative APBI in Stage I and Stage IIA breast cancers.

  This will be done by using 3D-CRT by evaluating the prescription isodose curves, dose inhomogeneity, and coverage of the volume as defined by CT treatment planning to delineate the target volume.

  5 years

Secondary Outcomes (1)

• Evaluation of pathologic response, cosmetic results, of lumpectomy wound healing and the overall complication rate, ipsilateral breast recurrence rate

  5 years

Study Arms (1)

Single Arm

OTHER

Phase II-Preoperative Radiation followed by Lumpectomy

Other: Phase II - Preoperative Radiation followed by Lumpectomy.

Interventions

Phase II - Preoperative Radiation followed by Lumpectomy. OTHER

Sequential investigative question. All procedures are standard of care

Single Arm

Eligibility Criteria

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

You may qualify if:

• Women who satisfy all of the following conditions are the only patients who will be eligible for this study:
• Patient must have invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies.
• AJCC Stage I or IIA (T1N0 or T2N0) histologically confirmed invasive carcinoma of the breast with a primary lesion (less than/equal to 3 cm)by MRI or ultrasound
• Clinically negative axillary lymph nodes. Standard routine imaging assessment of the axilla is performed by either ultrasound or MRI. If lymph nodes are suspicious, a biopsy is required. An involved axilla is purposely excluded.
• Unifocal breast cancer (single focus which can be encompassed by one lumpectomy).
• Patients must have an estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth receptor 2 (H2N) analyses performed on the primary tumor prior to enrollment.
• Based on pre-treatment planning CT scan, the ratio of the PTV to the reference breast volume should not exceed 25%.
• Patients must be greater than/equal to 18 years of age.
• Pretreatment evaluations required for eligibility include: bilateral mammogram, histologic confirmation of malignancy, and physical exam.
• Signed study-specific informed consent form prior to study entry.
• Women of childbearing potential must use an effective contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills.

You may not qualify if:

• Men are not eligible for this study. Women with one or more of the following conditions also are ineligible for this study:
• Evidence of suspicious microcalcifications which are separate from the known lesion unless pathologically confirmed to be benign.
• Patient with distant metastases.
• Patients with invasive lobular or extensive in-situ lobular carcinoma or pure ductal carcinoma in-situ or non-epithelial breast malignancies such as sarcoma or lymphoma.
• Patients with proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm) or with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy.
• Patient whose tumor is not visible on radiation treatment planning CT scan
• Palpable or radiographically suspicious ipsilateral axillary, supraclavicular, infraclavicular or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
• Prior hormonal or non-hormonal therapy or radiation therapy for the current breast cancer.
• Patients with Paget's disease of the nipple.
• Patients with skin involvement, regardless of tumor size.
• Patients with a breast technically unsatisfactory for radiation therapy.
• Patients with collagenous diseases, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis.
• Patients with co-existing medical conditions with life expectancy less than 2 years.
• Patients with psychiatric or addictive disorders that would preclude obtaining informed consent.
• Patients who are pregnant or lactating due to potential exposure of the fetus to RT and unknown effects of RT to lactating females.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (3)

Ummc Msgcc

Baltimore, Maryland, 21201, United States

Location

Central Maryland Oncology Center

Columbia, Maryland, 21044, United States

Location

Baltimore Washington Medical Center

Glen Burnie, Maryland, 21061, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Wendla Citron, MD

  UMMC MSGCC Department of Radiation Oncology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 16, 2009
• First Posted: November 17, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: November 12, 2018
• Last Updated: September 12, 2019

Record last verified: 2019-09

Locations

US (3)