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Breast NeoplasmsPhase 1/2NCT00325598

Partial Breast Irradiation (PBI) for Selected Patients With Early Breast Cancer

A Phase 1/2 study testing Partial Breast Irradiation (PBI) in people with Breast Neoplasms, run by Washington University School of 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

This study investigates the feasibility and safety of delivering radiation therapy only to part of the breast, (the tumor bed and selected areas) rather than the whole breast, for patients with early stage breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
Partial Breast Irradiation (PBI)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
14 Feb 2006to 16 Apr 2017
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologic Documentation:
  • Patients will have histologically confirmed Unicentric Stage I (T1 N0 M0) invasive ductal breast cancer.
  • Histologically negative tumor margin 2 mm or more from any inked edges, or no tumor in a re-excision specimen or final shaved specimen.
  • Tubular, mucinous and medullary variant histologies of infiltrating ductal carcinoma are permitted.
  • Low-grade DCIS (I and II) of 2 cm or less with histologically negative margins of at least 2 mm margins (or a negative re-excision) are permitted.
  • Women age 70 years or older with T1 invasive ductal carcinoma which are estrogen-receptor positive (ER+) with clinically negative axillary nodes who do not undergo surgical lymph node evaluation are also eligible if patient will take hormonal therapy.
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  • Patients with T1N0 (i+) tumors on sentinel lymph node mapping or dissection (i.e. is tumor deposit is 0.2mm or less, regardless of whether the deposit is detected by IHC or H\&E staining) will also be eligible, provided that completion axillary dissection has been performed to confirm N0 status.
  • In the case where invasive cancer is present, the invasive cancer's pathology will be used regardless if DCIS is also present.
  • Prior Treatment: Patient may have been treated with adjuvant chemotherapy. Patients may be on adjuvant hormonal therapy or begin hormonal therapy following XRT at the discretion of the medical oncologist.
  • Radiation therapy should begin within:
  • 4-12 weeks from definitive surgical procedure
  • 2-6 weeks after chemotherapy, if chemotherapy given first
  • Radiation cannot be delivered concurrently with chemotherapy.
  • Age >= 18 years of age
  • ECOG Performance Status 0-2.
  • Signed Informed Consent

Who cannot join

  • The following guidelines are to assist physicians in selecting patients for whom protocol therapy is safe and appropriate. Physicians should recognize that the following may seriously increase the risk to the patient entering this protocol. Patients who meet the following criteria should not be entered in this study:
  • 1a Multicentric IDC of the breast defined as discontiguous tumors separated by at least 5 cm of uninvolved tissue; alternatively, discontiguous tumors that are clinically or mammographically within separate breast quadrants or subareolar central region.
  • b Multifocal IDC of the breast, defined as discontiguous discrete foci of invasive carcinoma, separated by uninvolved intervening tissue, but within an overall span of 5cm, or within the same breast quadrant or subareolar central region.
  • Tumor > 2.0 cm, nodal involvement on H\&E staining, or metastatic involvement
  • Histological evidence of:
  • Lymphovascular invasion: as defined by a tumor embolus present in an endothelial-lined space; cases with tumor emboli present in a space not lined by endothelial cells but otherwise very suspicious for an angiolymphatic space were also considered ineligible.
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  • EIC (Extensive Intraductal Component): defined as the presence of intraductal carcinoma both within the primary infiltrating ductal tumor (comprising at least 25% of the tumor area) and intraductal carcinoma present clearly beyond the edges of the invasive tumor, or as a predominantly intraductal tumor with one or more areas of focal invasion 7, 55.
  • Invasive Lobular Carcinoma
  • Infiltrating carcinoma with mixed ductal and lobular features: cases with ambiguous or mixed histologic features that showed positive E-cadherin staining throughout the tumor by immunohistochemistry were classified as ductal type and considered eligible 56, 57.
  • Infiltrating papillary carcinoma
  • Margins: In-situ or invasive carcinoma present less than 2 mm from the inked resection margin.
  • History of cosmetic or reconstructive breast surgery
  • Psychiatric illness which would prevent the patient from giving informed consent. Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or connective tissue diseases (lupus, systemic sclerosis or other collagen vascular diseases) which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
  • Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and considered by their physician to be at less than 5% risk of relapse within three years.
  • Patients with diffuse (> 1 quadrant or > 5cm) suspicious microcalcifications
  • Women who are pregnant.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Partial Breast Irradiation (PBI) for Selected Patients With Early Breast Cancer: A Phase I/II Feasibility Study

This study investigates the feasibility and safety of delivering radiation therapy only to part of the breast, (the tumor bed and selected areas) rather than the whole breast, for patients with early stage breast cancer.

Being tested
Partial Breast Irradiation (PBI)
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Partial Breast Irradiation (PBI)Radiation

Study groups in NCT00325598
Study groupRoleWhat they receive
Cohort 1 (36 Gy)Experimental36 Gy in 9 fractions BID x 4 1/2 treatment days
Receives: Radiation: Partial Breast Irradiation (PBI)
Cohort 2 (40 Gy)Experimental40 Gy in 10 fractions BID over 5 treatment days
Receives: Radiation: Partial Breast Irradiation (PBI)

What is being measured

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

  1. Feasibility of PBI Directed External Radiotherapy as Measured by Percentage of Participants Achieving a Dosimetrically Satisfactory Treatment Plan

    -The study will be deemed infeasible if more than 4 patients cannot be given treatment because her tumor is such that a dosimetrically satisfactory treatment plan cannot be devised for her.

    Measured: Within 1 year of protocol registration

  2. Feasibility of PBI Directed External Radiotherapy as Measured by Development of Histological Fat Necrosis or Other Grade 4 Skin or Grade 4 Subcutaneous Toxicity, or Requires Surgery for the Skin/Subcutaneous Toxicity

    -The study will be deemed infeasible if more than 4 patients develop histological fat necrosis or other grade 4 skin or grade 4 subcutaneous toxicity, or requires surgery for her skin or subcutaneous toxicity

    Measured: Within 1 year of protocol registration

Secondary outcomes (7)

  1. Incidence and Severity of Cutaneous Toxicity

    • Uses RTOG/EORTC Late Radiation Morbidity Scoring Scheme
    • Grade 0 = none
    • Grade 1 = slight atrophy; pigmentation change; some hair loss
    • Grade 2 = patch atrophy; moderate telangiectasia; total hair loss
    • Grade 3 = marked atrophy; gross telangiectasia
    • Grade 4 = ulceration
    • Worst cutaneous toxicity grade is noted

    Measured: Up to 5 years

  2. Incidence of Breast Fibrosis

    Measured: Up to 5 years

  3. Incidence of Fat Necrosis

    -Fat necrosis typically causes a painless mass located superficially in the breast, accompanied by retraction or dimpling of the overlying skin. The skin may be thickened clinically and radiologically. Fat necrosis is firm and relatively circumscribed on palpation. Mammography usually reveals a spiculated, often poorly defined mass that may contain punctate or large, irregular calcifications. Attachment to the skin, dimpling, and thickening of the skin are often evident. Less frequently, the lesion consists of a circumscribed, oil-filled, partly calcified cyst. Early in its development, fat necrosis has the appearance of hemorrhage in indurated fat. After several weeks, the affected area becomes demarcated, forming a distinct yellow-gray and focally reddish tumor. Cystic degeneration may develop in the center of such a lesion, resulting in a cavity that contains oily fluid or necrotic fat.

    Measured: Up to 5 years

  4. Cosmetic Outcome

    • Excellent: little or no observable change
    • Good: minimal but identifiable changes
    • Fair: significant results of radiotherapy noted
    • Poor: severe normal tissue sequelae

    Measured: Up to 5 years

  5. Local Control Rate

    -Local control rate for this study is the number of participants who remained free of disease in their breast.

    Measured: Up to 5 years

  6. Regional Control Rate

    -Regional control rate for this study is the number of participants who remained free from disease in the regional lymph nodes. The regional lymph nodes are the axilla, infraclavicular, supraclavicular, and internal mammary lymph node beds

    Measured: Up to 5 years

  7. Distant Control Rate

    -Distant control rate for this study is the number of participants who remained free of cancer at distant sites which is defined as all parts of the body that are not the ipsilateral breast or ipsilateral regional lymph nodes.

    Measured: Up to 5 years

Timeline

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

  1. First posted15 May 2006 (estimated)
  2. Study start14 Feb 2006
  3. Primary completion16 Apr 2013
  4. Study completion16 Apr 2017

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00325598
Sponsor's protocol ID
05-1053 / 201103235
Status last verified
May 2018
First submitted
12 May 2006
Last updated
6 Jun 2018
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Partial Breast Irradiation (PBI) in people with Breast Neoplasms, run by Washington University School of 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?

The sponsor lists 16 inclusion and 16 exclusion criteria. 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 6 Jun 2018. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Feasibility of PBI Directed External Radiotherapy as Measured by Percentage of Participants Achieving a Dosimetrically Satisfactory Treatment Plan (time frame: Within 1 year of protocol registration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00325598.

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 6 Jun 2018; AzTrials last refreshed its copy on 7 Nov 2026.

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