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Accelerated Partial Breast Irradiation

18 Years
Open (Enrolling)
Breast Cancer, Long-Term Effects Secondary to Cancer Therapy in Adults, Skin Reactions Secondary to Radiation Therapy

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Trial Information

Accelerated Partial Breast Irradiation


- 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

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

Inclusion Criteria


- 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

- 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


- 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


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:


Principal Investigator

Lilie Lin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania


United States: Federal Government

Study ID:




Start Date:

January 2005

Completion Date:

Related Keywords:

  • Breast Cancer
  • Long-term Effects Secondary to Cancer Therapy in Adults
  • Skin Reactions Secondary to Radiation Therapy
  • long-term effects secondary to cancer therapy in adults
  • skin reactions secondary to radiation therapy
  • stage I breast cancer
  • stage II breast cancer
  • invasive lobular breast carcinoma with predominant in situ component
  • invasive lobular breast carcinoma
  • comedo ductal breast carcinoma
  • ductal breast carcinoma in situ
  • invasive ductal breast carcinoma
  • 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 intraductal carcinoma
  • Paget disease of the breast with invasive ductal carcinoma
  • breast cancer in situ
  • Breast Neoplasms



Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283