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Breast CancerNCT00599989

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

A study testing adjuvant therapy, conventional surgery and 3-dimensional conformal radiation therapy in people with Breast Cancer and Long-term Effects Secondary to Cancer Therapy in Adults, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 120 years, women only
What is being tested?
adjuvant therapy, conventional surgery and 3-dimensional conformal radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited States
Study dates
Jan 2005to 11 May 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-4283

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
adjuvant therapy, conventional surgery, 3-dimensional conformal radiation therapy, brachytherapy, intracavitary balloon brachytherapy
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
Medical subject headings
Breast Neoplasms, Carcinoma, Lobular, Carcinoma, Intraductal, Noninfiltrating, Carcinoma, Ductal, Breast, Breast Carcinoma In Situ

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • adjuvant therapyProcedure or surgery

  • conventional surgeryProcedure or surgery

  • 3-dimensional conformal radiation therapyRadiation

  • brachytherapyRadiation

  • intracavitary balloon brachytherapyRadiation

  • proton beam radiation therapyRadiation

Study groups in NCT00599989
Study groupRoleWhat they receive
APBIExperimentalNot described
Receives: Procedure: adjuvant therapy; Procedure: conventional surgery; Radiation: 3-dimensional conformal radiation therapy; Radiation: brachytherapy; Radiation: intracavitary balloon brachytherapy; Radiation: proton beam radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 11 months

Secondary outcomes (4)
  1. Late toxicity and cosmesis as assessed at or before 3 years from the start of radiotherapy and every 3 months during follow-up

    Measured: 11 months

  2. Site of disease recurrence (i.e., local, regional, or distant)

    Measured: 11 months

  3. Time to recurrence

    Measured: 11 months

  4. Time to locoregional recurrence

    Measured: 11 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2008 (estimated)
  2. Study startJan 2005
  3. Primary completion11 May 2009
  4. Study completion11 May 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00599989
Sponsor's protocol ID
CDR0000581427
Other IDs
UPCC-08104, UPCC-IRB-801897
Status last verified
Apr 2019
First submitted
11 Jan 2008
Last updated
9 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing adjuvant therapy, conventional surgery and 3-dimensional conformal radiation therapy in people with Breast Cancer and Long-term Effects Secondary to Cancer Therapy in Adults, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute toxicity as assessed by NCI CTC at 1 week, 4 weeks, and 3 months after completion of study therapy (time frame: 11 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.

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