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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00599989
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 24, 2008
Last Update Posted : July 9, 2009
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Long-Term Effects Secondary to Cancer Therapy in Adults Skin Reactions Secondary to Radiation Therapy Procedure: adjuvant therapy Procedure: conventional surgery Radiation: 3-dimensional conformal radiation therapy Radiation: brachytherapy Radiation: intracavitary balloon brachytherapy Radiation: proton beam radiation therapy Not Applicable

Detailed Description:


  • 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  (Clinical Trial)
Estimated Enrollment : 100 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Accelerated Partial Breast Irradiation
Study Start Date : January 2005
Estimated Primary Completion Date : January 2010

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. Late toxicity and cosmesis as assessed at or before 3 years from the start of radiotherapy and every 3 months during follow-up
  2. Site of disease recurrence (i.e., local, regional, or distant)
  3. Time to recurrence
  4. Time to locoregional recurrence

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00599989

United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Sponsors and Collaborators
University of Pennsylvania
National Cancer Institute (NCI)
Principal Investigator: Lilie Lin, MD Abramson Cancer Center of the University of Pennsylvania Identifier: NCT00599989     History of Changes
Other Study ID Numbers: CDR0000581427
First Posted: January 24, 2008    Key Record Dates
Last Update Posted: July 9, 2009
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes