Partial Breast Radiation Therapy in Treating Women Undergoing Breast Conservation Therapy for Early-Stage Breast Cancer

Breast Cancer Clinical Trial

Official title:

Accelerated Partial Breast Irradiation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00599989
• Other study ID #: CDR0000581427
• Secondary ID: UPCC-08104UPCC-I
• Status: Completed
• Phase: N/A
• Start date: January 2005
• Est. completion date: May 11, 2009

Study information

• Verified date: April 2019
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells.

PURPOSE: This clinical trial is studying the side effects of partial breast radiation therapy and how well it works in treating women undergoing breast conservation therapy for early-stage breast cancer.

Description:

OBJECTIVES:

• To allow women undergoing breast conservation therapy for early-stage breast cancer to have access to accelerated partial breast irradiation therapy on a controlled trial.

• To capture prospective data on acute and late toxicity and disease recurrence in patients treated with this therapy.

• To summarize the institutional experience of these patients treated with this experimental therapy.

OUTLINE: Within 9 weeks after surgery, patients undergo accelerated partial breast irradiation (including conformal external-beam irradiation, interstitial brachytherapy, intracavitary brachytherapy, or proton beam irradiation) twice daily for 5 days (10 fractions).

After completion of study therapy, patients are followed every 3 to 6 months for at least 5 years and then annually thereafter.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 11, 2009
• Est. primary completion date: May 11, 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Women who have chosen to undergo breast conservation therapy, including lumpectomy and breast irradiation, at the University of Pennsylvania for any invasive mammary carcinoma or intraductal breast cancer

• Stage I-II invasive or intraductal breast cancer

• Unifocal tumor = 3.0 cm in size

• Patients with microscopic multifocality are eligible provided total pathologic tumor size is = 3 cm

• No proven multicentric carcinoma in more than 1 quadrant or separated by 4 or more centimeters

• Pre- or post-biopsy ipsilateral* breast MRI negative for multicentric disease (i.e., areas of cancer that cannot be removed in a single excision specimen) or other suspicious findings NOTE: *Patients with synchronous bilateral breast cancers who will be treated with radiotherapy to each breast are eligible, provided such treatment can be performed in a manner that avoids overlap between treatment fields. Both sides may be treated with partial breast irradiation (PBI) if the pathologic eligibility criteria are met for both tumors, or only one side may be treated with PBI if the criteria are met for only one tumor.

• Negative margins of excision (= 2 mm) OR no tumor seen in a re-excision specimen

• No extensive intraductal component present

• Negative sentinel lymph node (SLN) or axillary lymph node dissection OR fewer than 4 positive nodes on adequate axillary lymph node dissection (i.e., 10 or more lymph nodes removed)

• If a SLN is positive on hematoxylin and eosin (but not by immunohistochemistry alone), complete axillary lymph node dissection is required

• Axillary lymph node staging is not required for patients with ductal carcinoma in situ

• No SLN identified in the internal mammary nodes

• No node > 2 cm

• No node with extracapsular extension

• Surgical clips placed in the operative bed OR ability to visualize operative bed on CT scan of the breast

• Target lumpectomy cavity/whole breast reference volume must be = 30% based on the treatment planning CT scan

• No diffuse calcifications on diagnostic mammogram

• Negative post-biopsy mammogram required if presented with mammographically detected microcalcifications

• Hormone receptor status unspecified

PATIENT CHARACTERISTICS:

• Female

• Menopausal status not specified

• History of non-breast malignancies allowed provided patients have been disease free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence

• Treated carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, or basal cell and squamous cell skin cancer within the past 5 years allowed

• Patients must agree to undergo breast MRI

• No contraindication to MRI, including a pacemaker or other foreign body

• Not pregnant or nursing

• No technical impediment to appropriate dosimetry

• No personal history of collagen vascular disease

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior in-field irradiation

• No presence of breast implant

• No breast reconstructive surgery prior to study entry

• No prior neoadjuvant chemotherapy or hormonal therapy

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Long-term Effects Secondary to Cancer Therapy in Adults
• Neoplasm Metastasis
• Skin Reactions Secondary to Radiation Therapy

Intervention

Procedure:
• adjuvant therapy

• conventional surgery

Radiation:
• 3-dimensional conformal radiation therapy

• brachytherapy

• intracavitary balloon brachytherapy

• proton beam radiation therapy

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute toxicity as assessed by NCI CTC at 1 week, 4 weeks, and 3 months after completion of study therapy		11 months
Secondary	Late toxicity and cosmesis as assessed at or before 3 years from the start of radiotherapy and every 3 months during follow-up		11 months
Secondary	Site of disease recurrence (i.e., local, regional, or distant)		11 months
Secondary	Time to recurrence		11 months
Secondary	Time to locoregional recurrence		11 months