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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Maryland
Sponsor:
Information provided by (Responsible Party):
Department of Radiation Oncology, University of Maryland
ClinicalTrials.gov Identifier:
NCT01014715
First received: November 16, 2009
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Other: Phase II - Preoperative Radiation followed by Lumpectomy.
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Preoperative Accelerated Partial Breast Irradiation (APBI) for Women With Stage I and Select IIA Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • The primary endpoint of this study is determination of the reproducibility of delivering preoperative APBI in Stage I and Stage IIA breast cancers. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Evaluation of pathologic response, cosmetic results, of lumpectomy wound healing and the overall complication rate, ipsilateral breast recurrence rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    These endpoints will be accomplished by utilizing the pathology report; the cosmesis will be judged by the patient, radiation oncologist and/or surgeon, at stated follow-up intervals; and the breast recurrence rate will be evaluated by disease status at routine patient follow-up appointments, including yearly mammography.


Estimated Enrollment: 40
Study Start Date: September 2009
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Arm
Phase II-Preoperative Radiation followed by Lumpectomy
Other: Phase II - Preoperative Radiation followed by Lumpectomy.
Sequential investigative question. All procedures are standard of care

Detailed Description:

This study will evaluate the feasibility, cosmetic results, complication rates, and local control rate of 3D-CRT confined to the region of the lumpectomy cavity for patients with Stage I and IIa (less than or equal to 3 cm) carcinoma of the breast (non-lobular histology) treated with APBI using 3D-CRT before lumpectomy. For selected patients with Stage I and II breast carcinoma, 3D-CRT delivered to the primary tumor preoperatively is technically reproducible with acceptable complication rates. Cosmetic results after partial breast irradiation before lumpectomy will be comparable to that obtained after whole breast external beam radiation therapy. The local tumor control rate in the breast after partial breast irradiation therapy followed by lumpectomy will be comparable to that of conventional external beam radiation therapy, with less inconvenience and potentially less cost to the patient, given the selection criteria which minimize the risk of clinically significant multicentric or extensive residual carcinoma following lumpectomy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Women who satisfy all of the following conditions are the only patients who will be eligible for this study:

  1. Patient must have invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies.
  2. 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
  3. 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.
  4. Unifocal breast cancer (single focus which can be encompassed by one lumpectomy).
  5. 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.
  6. Based on pre-treatment planning CT scan, the ratio of the PTV to the reference breast volume should not exceed 25%.
  7. Patients must be greater than/equal to 18 years of age.
  8. Pretreatment evaluations required for eligibility include: bilateral mammogram, histologic confirmation of malignancy, and physical exam.
  9. Signed study-specific informed consent form prior to study entry.
  10. 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.

Exclusion Criteria:

Men are not eligible for this study. Women with one or more of the following conditions also are ineligible for this study:

  1. Evidence of suspicious microcalcifications which are separate from the known lesion unless pathologically confirmed to be benign.
  2. Patient with distant metastases.
  3. 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.
  4. 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.
  5. Patient whose tumor is not visible on radiation treatment planning CT scan
  6. Palpable or radiographically suspicious ipsilateral axillary, supraclavicular, infraclavicular or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
  7. Prior hormonal or non-hormonal therapy or radiation therapy for the current breast cancer.
  8. Patients with Paget's disease of the nipple.
  9. Patients with skin involvement, regardless of tumor size.
  10. Patients with a breast technically unsatisfactory for radiation therapy.
  11. Patients with collagenous diseases, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis.
  12. Patients with co-existing medical conditions with life expectancy less than 2 years.
  13. Patients with psychiatric or addictive disorders that would preclude obtaining informed consent.
  14. Patients who are pregnant or lactating due to potential exposure of the fetus to RT and unknown effects of RT to lactating females.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01014715

Contacts
Contact: Bahiyyah Jackson, MS 410-328-7586 bjackson1@umm.edu
Contact: Nancy Kennedy, RN, BSN 410-328-2513 nkennedy@umm.edu

Locations
United States, Maryland
Ummc Msgcc Recruiting
Baltimore, Maryland, United States, 21201
Contact: Bahiyyah Jackson, MS    410-328-7586    bjackson1@umm.edu   
Contact: Nancy Kennedy, RN, BSN    410-328-2513    nkennedy@umm.edu   
Principal Investigator: Steven Feigenberg, MD         
Central Maryland Oncology Center Recruiting
Columbia, Maryland, United States, 21044
Contact: Michelle Morgan    443-546-1300    mmorgan@umm.edu   
Contact: Nancy Kennedy, RN,BSN    410-328-2513    nkennedy@umm.edu   
Sub-Investigator: Sally Cheston, MD         
Baltimore Washington Medical Center Recruiting
Glen Burnie, Maryland, United States, 21061
Contact: Pilar Strycula, RN, BSN    410-553-8110    Pstrycula@bwmc.umms.org   
Sub-Investigator: Wendla Citron, MD         
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Steven Feigenberg, MD UMMC MSGCC Department of Radiation Oncology
  More Information

No publications provided

Responsible Party: Department of Radiation Oncology, Prinicipal Investigator, University of Maryland
ClinicalTrials.gov Identifier: NCT01014715     History of Changes
Other Study ID Numbers: HP-00042098, GCC 0919
Study First Received: November 16, 2009
Last Updated: April 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 28, 2014