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Partial Breast Treatment Using Single Dose Intraoperative Radiotherapy for Patients With Early Stage Breast Cancer - A Feasibility Study With Molecular Analysis of Tumors and Normal Breast Epithelial Tissue


Phase 2
48 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Partial Breast Treatment Using Single Dose Intraoperative Radiotherapy for Patients With Early Stage Breast Cancer - A Feasibility Study With Molecular Analysis of Tumors and Normal Breast Epithelial Tissue


OBJECTIVES:

Primary

- Determine the feasibility of intraoperative partial breast radiotherapy prior to
surgical resection in older women with low-risk early stage primary invasive ductal
carcinoma of the breast.

- Determine the rate of good/excellent cosmesis, as measured by the RTOG cosmetic rating
scale, in patients treated with this regimen.

- Compare the cosmetic outcome in patients treated with this regimen with that of
patients treated with partial breast brachytherapy in clinical trial RTOG-9517.

- Determine the incidence of grade 3-4 toxicity of this regimen in these patients.

- Determine the rate of ipsilateral breast recurrence, including recurrence within the
tumor bed as compared to elsewhere in the breast, in patients treated with this
regimen.

Secondary

- Determine the radiation-induced activation of receptors and signal transduction
pathways involved in radiation response in patients treated with this regimen.

OUTLINE: This is a non-randomized study.

Patients undergo intraoperative lymphatic mapping and sentinel lymphadenectomy OR standard
level I, II axillary dissection to evaluate the lymph nodes followed by intraoperative
breast ultrasonography to define the tumor target volume. Patients then undergo
intraoperative single-dose partial breast radiotherapy followed by segmental mastectomy
(i.e., lumpectomy) of the tumor. Patients with 1 or 2 tumor-involved surgical margins may
undergo repeat segmental mastectomy. Patients with > 2 tumor-involved surgical margins
undergo mastectomy. Patients determined to have a tumor size > 3 cm or an extensive
intraductal component on final pathology evaluation undergo standard external beam
radiotherapy after surgery.

After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study within 2 to 3
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed primary invasive ductal carcinoma of the breast

- Tumor size ≤ 3 cm

- No extensive intraductal component

- Tumor must not be attached to the skin, underlying muscle, or chest wall

- Candidate for breast-conserving therapy, as determined by the surgical and radiation
oncologist

- Tumor amenable to segmental mastectomy (i.e., lumpectomy)

- No bilateral breast cancer

- No clinical or radiographic multifocal disease not amenable to single segmental
mastectomy

- Patients with > 1 tumor mass in the same breast must have only 1 mass that is
histologically malignant AND all other masses must be proven histologically
benign

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age

- 48 and over

Sex

- Female

Menopausal status

- Not specified

Performance status

- 0-2

Life expectancy

- At least 5 years

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Other

- Not pregnant

- Fertile patients must use effective contraception

- No collagen vascular disease

- No medical condition that would preclude surgery

- Other prior malignancy allowed provided the following criteria are met:

- Patient has undergone potential curative therapy for all prior malignancies

- There is no evidence of any prior malignancy within the past 5 years

- Patient is deemed to be at low risk for recurrence of prior malignancy, as
determined by the treating physician

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy for this malignancy

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy to the breast

Surgery

- No breast implants

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rates of good/excellent cosmesis as measured by the RTOG cosmetic rating scale

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

David Olilla, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

LCCC 0218

NCT ID:

NCT00182728

Start Date:

February 2003

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • invasive ductal breast carcinoma
  • stage I breast cancer
  • stage II breast cancer
  • Breast Neoplasms

Name

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570