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Breast Cancer FemaleAPBINCT03437395

Accelerated Partial Breast Irradiation Study

A study testing Balloon Brachytherapy and 3D Conformal External Beam Irradiation in people with Breast Cancer Female, run by Sentara Norfolk General Hospital at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Breast cancer patients at Sentara RMH Hahn Cancer Center who are treated with accelerated partial breast irradiation will be monitored over a period of 10 years. From this group of patients, local and regional recurrence rates will be determined. Read more about this study

Who is it for?
Ages 50 years and older, women only
Conditions the study is for
Breast Cancer Female
What is being tested?
Balloon Brachytherapy and 3D Conformal External Beam Irradiation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
139 participants
Where
1 siteUnited States
Study dates
11 Mar 2009to Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • The patient must consent to be in the study and must have signed an approved consent form approved by Sentara RMH Medical Center's IRB.
  • Patients must be >/= 50 years or postmenopausal.
  • The patient must have stage 0 or 1 breast cancer.
  • On histological examination, the tumor must be DCIS or invasive non- lobular carcinoma of the breast.
  • Surgical treatment of the breast must have lumpectomy. The margins of the resected specimen must be histologically free of tumor (DCIS and in- vasive) by 2 mm or more. Reexcision of surgical margins is permitted.
  • Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 2 cm or less. Mucinous or tubular histologies maximum size may be up to 3 cm.
Show all 33Show fewer
  • Patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone (if sentinel node is negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes including the sentinel nodes (if sentinel node is positive), or axillary dissection alone (with a minimum of 6 axillary nodes.) (Axillary staging is not required for patients with DCIS).
  • The patient must begin treatment within 9 weeks following the last surgery for breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure).
  • Patients must have an estrogen receptor (ER) and progesterone receptor (PR) analysis performed on the primary tumor prior to enrollment.
  • The target lumpectomy cavity must be clearly delineated and the ratio of target lumpectomy cavity/whole breast reference volume must be </= 25% based on the postoperative CT scan.
  • Patients are eligible if, based on the postoperative CT scan, PBI is judged to be technically deliverable by either 3D conformal radiation therapy or balloon brachytherapy.
  • At the time of study entry, patients must have had an H\&P within 4 months and a bilateral mammogram within 6 months.
  • Patients with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior to study entry and are deemed by their physician to be low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
  • Exclusion Criteria: Men are not eligible for this study. Women with one or more of the following conditions are ineligible for this study.
  • Stage II, Stage III, or Stage IV Breast Cancer
  • Histologically positive axillary on non-axillary nodes.
  • Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
  • Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
  • Non-epithelial breast malignancies such as sarcoma or lymphoma.
  • Proven multicentric carcinoma (invasive or DCIS) in more than one quadrant or separated by 4 or more cm.
  • Paget's disease of the nipple.
  • Synchronous bilateral invasive or non-invasive breast cancer.
  • History of invasive breast cancer or DCIS in the ipsilateral breast (Patients with a history of LCIS treated by surgery alone are eligible).
  • Surgical margins that cannot be microscopically assessed or are less than 2 mm at pathologic evaluation. (if surgical margins are rendered free of disease by re-excision, the patient is eligible).
  • Clear delineation of the extent of the target lumpectomy cavity not possible.
  • Treatment plan that includes regional nodal irradiation.
  • Any treatment with radiation therapy to the ipsilateral breast, chemo- therapy biotherapy, and/or hormonal therapy administered for the currently diagnosed breast cancer prior to study. 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 study entry. For patients receiving chemotherapy, hormonal therapy must stop at or before study entry and resume following completion of chemotherapy. For patients not receiving chemotherapy, hormonal therapy may continue.
  • Current therapy with any hormonal agents such as raloxifere (Evista), tamoxifen, or other selective receptor modulators (SERMs), either for osteoporosis or breast cancer prevention (patients are eligible only if these medications are discontinued prior to study entry).
  • Breast implants. (Patients who have implants removed are eligible)
  • Prior ipsilateral breast or thoracic RT for any condition.
  • Collagen vascular disease, specifically dermatomyositis with CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
  • Pregnancy or lactation at the time of proposed study entry. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sentara RMH Hahn Cancer Center

    Harrisonburg, Virginia, 22801

Other trials in United States

About this study

Official title: Accelerated Partial Breast Irradiation Study for Women With Stage 0 or 1 Breast Cancer

Breast cancer patients at Sentara RMH Hahn Cancer Center who are treated with accelerated partial breast irradiation will be monitored over a period of 10 years. From this group of patients, local and regional recurrence rates will be determined. Patients in the registry will also take part in assessments of cosmesis and quality of life.

Read the detailed description

Studies have shown that giving radiation therapy to the breast after lumpectomy helps keep cancer from coming back in the breast. The purpose of this study is to see if partial breast irradiation (PBI) at SRMH Hahn Cancer Center is as good as partial breast irradiation performed in other centers in the United States in keeping cancer from coming back in the breast. Whole breast irradiation (WBI) is a standard treatment after a lumpectomy. WBI is radiation therapy given 5 days a week for 5 to 7 weeks to the whole breast. PBI is a new method of delivering radiation only to the area of the breast where the cancer was removed. PBI is given 2 times a day for 5 days. PBI may be given over a period of 5 to 10 days. This newer treatment is currently being compared with WBI in a randomized trial. Thus far, patients at low risk for cancer recurrence who have been treated with PBI have had excellent outcomes at 5 years post-treatment, but we will not know for sure if PBI is as good as WBI until the results of the randomized trial are available. However, PBI is commonly being offered outside of clinical trials in many community hospitals throughout the country. As radiation oncologists at Sentara RMH Hahn Cancer Center, we wanted to offer patients in our community the same opportunity to have this treatment, but also wanted to ensure close follow-up of all patients treated with this method, to be sure our results are similar to those of patients reported in our professional literature. There are two different methods of PBI that are being used at SRMH Hahn Cancer Center: Balloon brachytherapy and 3-D conformal external beam irradiation. This study will learn about the good and bad effects of radiation therapy. The study also will learn about the feelings women have about how their breast looks after surgery and radiation therapy.

Being tested
Balloon Brachytherapy, 3D Conformal External Beam Irradiation
Keywords
Lumpectomy, Unifocal Disease, Stage 0 or 1 Disease

What participants receive

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

  • Balloon BrachytherapyDevice

    The balloon brachytherapy catheter method uses one tube with a small balloon on the end placed where the tumor had been. The balloon is filled with salt water so it fits this space. The end of the tube will extend from the side of the breast and will be connected to a special machine for treatments. The RT dose is delivered by a radioactive seed that travels through the tube into the center of the balloon. The seed will be removed at the end of each treatment. The tube and the balloon filled with salt water will stay in the breast until the 10 RT treatments are done. The radiation oncologist will decide if this type of treatment is most appropriate for the patient. The treatment will be given 2 times a day, about 6 hours apart, on 5 days. Each treatment lasts for 10-15 minutes.

  • 3D Conformal External Beam IrradiationRadiation

    3D conformal external beam irradiation uses a beam of radiation to deliver the radiation therapy dose to the place in the breast where the cancer was removed. The Radiation Oncologist will decide which type of treatment is most appropriate for the patient. The treatment will be given 2 times a day, about 6 hours apart, on 5 days. Each treatment lasts for 10 to 15 minutes.

Study groups in NCT03437395
Study groupRoleWhat they receive
Partial Breast IrradiationOtherAll participants will be treated with partial breast irradiation by utilizing 3D conformal external beam irradiation or balloon brachytherapy. This is not a randomized study.
Receives: Device: Balloon Brachytherapy; Radiation: 3D Conformal External Beam Irradiation

What is being measured

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

  1. Number of Participants with Local and Regional Recurrence after Partial Breast Irradiation as assessed by change in Physical Exam, Mammography, MRI, Scintimammography, Biopsy, and/or Surgical Pathology.

    At the time of analysis, recurrence rates in the study group will be compared to recurrence rates in stage 1 breast cancer patients with similar risk factors from the national studies of APBI and whole breast radiation therapy, to determine if SRMH recurrence rates are significantly different.

    Measured: Prior to radiation, 4 weeks post RT, 6 months post RT, then yearly up to 10 1/2 years Post RT

Secondary outcomes (1)

  1. Number of Participants with Certain Characteristics or Risk Factors in SRMH Population that are Associated with a Higher Risk for Recurrence when Using Partial Breast Irradiation as Assessed by History and Physical, Mammography, Pathology.

    At the time of analysis, it will also be determined whether these characteristics or risk factors in SRMH population are associated with a higher risk for recurrence when using this technique.

    Measured: prior to radiation, 4 weeks post RT, 6 months post RT, then yearly up to 10 1/0 years post RT

Timeline

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

  1. First posted19 Feb 2018
  2. Study start11 Mar 2009
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

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
Model description
Patients will be offered either balloon brachytherapy or 3D conformal radiation therapy to treat the tumor bed alone. Data will be collected so that our results can be compared to the results of the randomized trial. Specifically, we will be comparing our local control rates and cosmetic results to those of favorable risk patients from the NSABP B-39 trial.
Masking
None (open label)
Enrolment
139 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03437395
Sponsor's protocol ID
09.01
Acronym
APBI
Status last verified
Mar 2025
First submitted
3 Jan 2018
Last updated
2 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152.

    PubMed 12393820

  • Fisher ER, Dignam J, Tan-Chiu E, Costantino J, Fisher B, Paik S, Wolmark N. Pathologic findings from the National Surgical Adjuvant Breast Project (NSABP) eight-year update of Protocol B-17: intraductal carcinoma. Cancer. 1999 Aug 1;86(3):429-38. doi: 10.1002/(sici)1097-0142(19990801)86:33.0.co;2-y.

    PubMed 10430251

  • EORTC Breast Cancer Cooperative Group; EORTC Radiotherapy Group; Bijker N, Meijnen P, Peterse JL, Bogaerts J, Van Hoorebeeck I, Julien JP, Gennaro M, Rouanet P, Avril A, Fentiman IS, Bartelink H, Rutgers EJ. Breast-conserving treatment with or without radiotherapy in ductal carcinoma-in-situ: ten-year results of European Organisation for Research and Treatment of Cancer randomized phase III trial 10853--a study by the EORTC Breast Cancer Cooperative Group and EORTC Radiotherapy Group. J Clin Oncol. 2006 Jul 20;24(21):3381-7. doi: 10.1200/JCO.2006.06.1366. Epub 2006 Jun 26.

    PubMed 16801628

  • Polgar C, Fodor J, Major T, Nemeth G, Lovey K, Orosz Z, Sulyok Z, Takacsi-Nagy Z, Kasler M. Breast-conserving treatment with partial or whole breast irradiation for low-risk invasive breast carcinoma--5-year results of a randomized trial. Int J Radiat Oncol Biol Phys. 2007 Nov 1;69(3):694-702. doi: 10.1016/j.ijrobp.2007.04.022. Epub 2007 May 25.

    PubMed 17531400

  • Chao KK, Vicini FA, Wallace M, Mitchell C, Chen P, Ghilezan M, Gilbert S, Kunzman J, Benitez P, Martinez A. Analysis of treatment efficacy, cosmesis, and toxicity using the MammoSite breast brachytherapy catheter to deliver accelerated partial-breast irradiation: the william beaumont hospital experience. Int J Radiat Oncol Biol Phys. 2007 Sep 1;69(1):32-40. doi: 10.1016/j.ijrobp.2007.02.026. Epub 2007 Apr 30.

    PubMed 17467920

  • Vicini FA, Remouchamps V, Wallace M, Sharpe M, Fayad J, Tyburski L, Letts N, Kestin L, Edmundson G, Pettinga J, Goldstein NS, Wong J. Ongoing clinical experience utilizing 3D conformal external beam radiotherapy to deliver partial-breast irradiation in patients with early-stage breast cancer treated with breast-conserving therapy. Int J Radiat Oncol Biol Phys. 2003 Dec 1;57(5):1247-53. doi: 10.1016/s0360-3016(03)01573-6.

    PubMed 14630258

  • Haffty BG, Vicini FA, Beitsch P, Quiet C, Keleher A, Garcia D, Snider H, Gittleman M, Zannis V, Kuerer H, Whitacre E, Whitworth P, Fine R, Keisch M. Timing of Chemotherapy after MammoSite radiation therapy system breast brachytherapy: analysis of the American Society of Breast Surgeons MammoSite breast brachytherapy registry trial. Int J Radiat Oncol Biol Phys. 2008 Dec 1;72(5):1441-8. doi: 10.1016/j.ijrobp.2008.02.070. Epub 2008 Aug 7.

    PubMed 18692330

  • Martin Keish, M.D., Douglas Arthur, M.D., Rakesh Patel, M.D., Mark Rivard, PhD., Frank Vicini, M.D. February, 2007, American Brachytherapy Society Breast Brachytherapy Task Group. www.americanbrachytherapy.org/resources/abs_breast_brachytherapy_taskgroup.pdf

  • NSABP B-39, RTOG 0413: A Randomized Phase III Study of conventional whole breast irradiation versus partial breast irradiation for women with stage 0, I, or II breast cancer. Clin Adv Hematol Oncol. 2006 Oct;4(10):719-21. No abstract available.

    PubMed 17111558

Questions about this trial

What is this clinical trial studying?

A study testing Balloon Brachytherapy and 3D Conformal External Beam Irradiation in people with Breast Cancer Female, run by Sentara Norfolk General Hospital 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 33 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2025. 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?

This study is still under way. Results are not available in the source record yet.

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?

Number of Participants with Local and Regional Recurrence after Partial Breast Irradiation as assessed by change in Physical Exam, Mammography, MRI, Scintimammography, Biopsy, and/or Surgical Pathology. (time frame: Prior to radiation, 4 weeks post RT, 6 months post RT, then yearly up to 10 1/2 years Post RT). 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 NCT03437395, which also lists 9 linked publications.

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 2 Apr 2025.

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