Clinical trial NCT00599989: Partial Breast Radiation Therapy in Treating Women Undergoing Breast Conservation Therapy for Early-Stage Breast Cancer
Official title: Accelerated Partial Breast Irradiation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Long-term Effects Secondary to Cancer Therapy in Adults
Skin Reactions Secondary to Radiation Therapy
Keywords: 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
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-01-24
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute toxicity as assessed by NCI CTC at 1 week, 4 weeks, and 3 months after completion of study therapy
timeFrame: 11 months
Secondary outcomes:
measure: Late toxicity and cosmesis as assessed at or before 3 years from the start of radiotherapy and every 3 months during follow-up
timeFrame: 11 months
measure: Site of disease recurrence (i.e., local, regional, or distant)
timeFrame: 11 months
measure: Time to recurrence
timeFrame: 11 months
measure: Time to locoregional recurrence
timeFrame: 11 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Lilie Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: