CClinicalTrials.gg
CompletedNCT01014715GCC 0919Updated Sep 12, 2019

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

An interventional study of Phase II - Preoperative Radiation followed by Lumpectomy. in Breast Cancer, sponsored by University of Maryland, Baltimore. Completed at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-12.

Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breast Cancer

Browse trials for

Keywords

  • Breast Cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 32 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Other
    Single Arm

    Phase II-Preoperative Radiation followed by Lumpectomy

    Other: Phase II - Preoperative Radiation followed by Lumpectomy.

Interventions

  • OtherPhase II - Preoperative Radiation followed by Lumpectomy.

    Sequential investigative question. All procedures are standard of care

06

What researchers measure

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.

    Time frame: 5 years

Secondary outcomes

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

    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.

    Time frame: 5 years

07

Study locations

3 sites
  • Ummc Msgcc
    Baltimore, Maryland 21201, United States
  • Central Maryland Oncology Center
    Columbia, Maryland 21044, United States
  • Baltimore Washington Medical Center
    Glen Burnie, Maryland 21061, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01014715
Lead sponsor
University of Maryland, Baltimore
Responsible party
Department of Radiation Oncology (Prinicipal Investigator, University of Maryland, Baltimore) — Principal investigator
First posted
Nov 17, 2009
Start date
Sep 2009
Primary completion
Dec 2014
Completion
Nov 12, 2018
Last update
Sep 12, 2019

Study contacts

Wendla Citron, MD
principal investigator · UMMC MSGCC Department of Radiation Oncology

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion