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

Accelerated Partial Breast Irradiation

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Long-term Effects Secondary to Cancer Therapy in Adults; Skin Reactions Secondary to Radiation Therapy
• Intervention / Treatment: Procedure: adjuvant therapy; Procedure: conventional surgery; Radiation: brachytherapy; Radiation: 3-dimensional conformal radiation therapy; Radiation: intracavitary balloon brachytherapy; Radiation: proton beam radiation therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-4283
      • Abramson Cancer Center of The University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: APBI	Procedure: adjuvant therapy; Procedure: conventional surgery; Radiation: brachytherapy; Radiation: 3-dimensional conformal radiation therapy; Radiation: intracavitary balloon brachytherapy; Radiation: proton beam radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Acute toxicity as assessed by NCI CTC at 1 week, 4 weeks, and 3 months after completion of study therapy	11 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Site of disease recurrence (i.e., local, regional, or distant)	11 months
Time to recurrence	11 months
Time to locoregional recurrence	11 months

Collaborators and Investigators

• Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Lilie Lin, MD, Abramson Cancer Center of The University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): May 11, 2009
• Study Completion (Actual): May 11, 2009

Study Registration Dates

• First Submitted: January 11, 2008
• First Submitted That Met QC Criteria: January 11, 2008
• First Posted (Estimate): January 24, 2008

Study Record Updates

• Last Update Posted (Actual): April 9, 2020
• Last Update Submitted That Met QC Criteria: April 6, 2020
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: stage II breast cancer; stage I breast cancer; breast cancer in situ; long-term effects secondary to cancer therapy in adults; ductal breast carcinoma in situ; invasive ductal breast carcinoma; invasive lobular breast carcinoma; invasive lobular breast carcinoma with predominant in situ component; medullary ductal breast carcinoma with lymphocytic infiltrate; mucinous ductal breast carcinoma; papillary ductal breast carcinoma; tubular ductal breast carcinoma; Paget disease of the breast with invasive ductal carcinoma; comedo ductal breast carcinoma; skin reactions secondary to radiation therapy; Paget disease of the breast with intraductal carcinoma
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Neoplastic Processes; Breast Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: CDR0000581427; UPCC-08104; UPCC-IRB-801897

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes