Accelerated Partial Breast Irradiation Study

NCT ID: NCT03437395

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-11
• Study Completion Date: 2025-12-31

Brief 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. Patients in the registry will also take part in assessments of cosmesis and quality of life.

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.

Conditions

Breast Cancer Female

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Partial Breast Irradiation

All participants will be treated with partial breast irradiation by utilizing 3D conformal external beam irradiation or balloon brachytherapy. This is not a randomized study.

Group Type: OTHER

Balloon Brachytherapy

Intervention Type: DEVICE

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 Irradiation

Intervention Type: RADIATION

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.

Interventions

Balloon Brachytherapy

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.

Intervention Type: DEVICE

3D Conformal External Beam Irradiation

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.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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.
• 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

• 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sentara Norfolk General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heather A. Morgan, MD

Role: PRINCIPAL_INVESTIGATOR

Sentara RMH Medical Center

Locations

Sentara RMH Hahn Cancer Center

Harrisonburg, Virginia, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 12393820 (View on PubMed)

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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 17531400 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17467920 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14630258 (View on PubMed)

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.

Reference Type: BACKGROUND

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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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 17111558 (View on PubMed)

Other Identifiers

09.01

Identifier Type: -

Identifier Source: org_study_id