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Breast CancerPhase 4NCT00882089

Use of the Contura™ Catheter in Intermediate-Risk, Pathological Stage 0, I, or II (Up to 3.0 cm) Breast Cancer Patients

A Phase 4 study testing Contura catheter in people with Breast Cancer, run by Cancer Center of Irvine 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

The purpose of this study is to determine if a Contura catheter can avoid a radiation "hot spot" in the skin and improve tissue-balloon conformance in early-stage breast cancer patients undergoing accelerated partial breast irradiation. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Contura catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
Oct 2007to Dec 2009
Phase
Phase 4
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone if sentinel node is negative or axillary dissection or sampling with a minimum total of 6 axillary nodes if sentinel node is positive. Axillary staging is not required for patients with DCIS.
  • Estrogen receptor (ER) and progesterone receptor (PR) analysis must be negative.
  • The patient must be ≥ 18 years old.
  • If the patient is older than 49 years, she must meet at least one of the following 2 conditions:
  • 1-3 histologically positive axillary nodes ii. negative ER and PR analysis
  • The patient should have a life expectancy of at least 10 years, excluding her diagnosis of breast cancer.
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  • The tumor must be DCIS or invasive adenocarcinoma of the breast.
  • Gross disease must be unifocal with pathologic tumor size 3.0 cm or less. Patients with microscopic multifocality are eligible as long as total pathologic tumor size is 3.0 cm or less.
  • The patient must have pathological stage 0, I, or II breast cancer.
  • Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (DCIS and invasive). Re-excision of surgical margins is permitted.
  • The patient must be registered within 42 days following the last surgery for breast cancer.
  • The target lumpectomy cavity/whole breast reference volume must be ≤ 30% based on the postoperative CT scan.

Who cannot join

  • The patient is < 18 years old.
  • If the patient is older than 49 years, she has both an ER and PR positive tumor and histologically negative axillary nodes.
  • T2 (> 3.0 cm), T3, stage III, or stage IV breast cancer.
  • "Marginal" or "borderline" ER or PR analysis results.
  • More than 3 histologically positive axillary nodes.
  • Axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension.
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  • One or more positive non-axillary sentinel node(s). Intramammary nodes are staged as axillary nodes.
  • Non-epithelial breast malignancies such as sarcoma or lymphoma.
  • Proven multicentric carcinoma in more than one quadrant or separated by 4 or more centimeters.
  • Paget's disease of the nipple.
  • Synchronous bilateral invasive or non-invasive breast cancer.
  • History of DCIS or invasive breast cancer.
  • Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation.
  • Clear delineation of the target lumpectomy cavity not possible.
  • Any treatment with radiation therapy, chemotherapy, and/or biotherapy administered for the currently diagnosed breast cancer prior to registration. The only exception is hormonal therapy, which may have been given for no more than a total of 28 days anytime after diagnosis and before registration.
  • Prior breast or thoracic radiotherapy for any condition.
  • Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
  • Pregnancy or lactation at the time of proposed registration. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.
  • Psychiatric or addictive disorders.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cancer Center of Irvine

    Irvine, California, 92618

Other trials in United States

About this study

Official title: Registry Study of the Contura™ Multi-Lumen Balloon (MLB) Applicator for Accelerated Partial Breast Irradiation in Intermediate-Risk, Pathological Stage 0, I, or II (Up to 3.0 cm) Breast Cancer Patients

The purpose of this study is to determine if a Contura catheter can avoid a radiation "hot spot" in the skin and improve tissue-balloon conformance in early-stage breast cancer patients undergoing accelerated partial breast irradiation.

Read the detailed description

In approximately 20% of patients who are considered for accelerated partial breast irradiation (APBI), the balloon-to-skin distance ranges from 3-6 mm. The Contura applicator has 5 source lumens. In contrast, the MammoSite catheter has a single source lumen. The ability to choose from multiple source lumens with the Contura catheter allows one to avoid a radiation "hot spot" in the skin in cases where the balloon-to-skin spacing is only 3-6 mm.

Another limitation of the MammoSite catheter is that one cannot improve on the suboptimal conformance of the balloon with the surrounding breast tissue. An air/fluid pocket next to the balloon can push breast tissue at greatest risk of harboring residual disease away from the radioactive source. With APBI, the planning target volume for plan evaluation (PTV_EVAL) is defined as the breast tissue volume bounded by uniform expansion of the balloon radius in all dimensions by 10 mm less the balloon volume. PTV_EVAL is limited to 5 mm from the skin surface and by the posterior breast tissue extent (chest wall and pectoralis muscles are excluded). The volume of an air/fluid pocket is usually 4.8% ± 1.1% (mean ± standard error) of PTV_EVAL. The Contura applicator has a vacuum lumen with 2 openings adjacent to the balloon that allow for air/fluid removal. By using the vacuum lumen on a Contura applicator, one can typically decrease the size of an air/fluid pocket by about one third. In approximately 90% of Contura patients, the volume of an air/fluid pocket around the balloon can be reduced to less than or equal to 3.0% of PTV_EVAL. In contrast, the volume of an air/fluid pocket around the balloon is less than or equal to 3.0% of PTV_EVAL in only about half of MammoSite patients. Since this study addresses intermediate-risk patients, it is particularly important that the size of an air/fluid pocket be minimized with a Contura applicator.

SenoRx, Inc. (Aliso Viejo, CA) is currently conducting a registry study of the Contura MLB applicator in the "low-risk" patient population. This "intermediate-risk" study is complimentary to the low-risk registry study. There is no overlap in patient eligibility. Intermediate-risk patients meet any of the following criteria:

  1. Age 18-49 years, or
  2. Estrogen receptor-negative and progesterone receptor-negative breast cancer, or
  3. 1-3 involved axillary lymph nodes
Conditions
Breast Cancer
Being tested
Contura catheter
Keywords
Contura, Cancer, Accelerated, Partial, Breast, Irradiation
Medical subject headings
Breast Neoplasms, Neoplasms

What participants receive

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

  • Contura catheterDevice

    Also called Contura Multi-Lumen Balloon Applicator

    Radiation therapy is delivered to a total dose of 34 Gy in 10 fractions bid over 5-7 days. Each day, the high dose rate iridium-192 brachytherapy treatments are separated by 6 hours. Each radiation treatment takes 15-30 minutes.

Study groups in NCT00882089
Study groupRoleWhat they receive
1ExperimentalA Contura balloon catheter is placed in the lumpectomy cavity. Later that morning, accelerated partial irradiation begins.
Receives: Device: Contura catheter

What is being measured

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

  1. Maximum skin dose is less than or equal to 100% of the prescribed radiation dose and air/fluid pocket next to the balloon is less than or equal to 3.0% of the planning target volume for plan evaluation

    Measured: 19 months

Secondary outcomes (1)

  1. Number of cases where the balloon catheter has to be explanted when the balloon-to-skin spacing is only 3-6 mm.

    Measured: 19 months

Timeline

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

  1. First posted16 Apr 2009 (estimated)
  2. Study startOct 2007
  3. Primary completionDec 2009
  4. Study completionDec 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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00882089
Sponsor's protocol ID
1098987
Status last verified
Jul 2013
First submitted
15 Apr 2009
Last updated
25 Jan 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Contura catheter in people with Breast Cancer, run by Cancer Center of Irvine 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 12 inclusion and 19 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 25 Jan 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

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?

Maximum skin dose is less than or equal to 100% of the prescribed radiation dose and air/fluid pocket next to the balloon is less than or equal to 3.0% of the planning target volume for plan evaluation (time frame: 19 months). 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 NCT00882089.

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 25 Jan 2018.

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