Clinical trial NCT03437395: Accelerated Partial Breast Irradiation Study
Official title: Accelerated Partial Breast Irradiation Study for Women With Stage 0 or 1 Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer Female
Keywords: Lumpectomy
Unifocal Disease
Stage 0 or 1 Disease
Lead sponsor: Sentara Norfolk General Hospital
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 139
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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: 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.

Primary outcomes:
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.
timeFrame: Prior to radiation, 4 weeks post RT, 6 months post RT, then yearly up to 10 1/2 years Post RT
Secondary outcomes:
measure: 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.
timeFrame: prior to radiation, 4 weeks post RT, 6 months post RT, then yearly up to 10 1/0 years post RT
Other outcomes:
measure: Number of Participants will have Cosmetic Results Assessed by Utilizing the Breast Cancer Treatment Outcome Scale (BCTOS) using Patient Self Reports and a Cosmetic Evaluation Will Be Made by the Radiation Oncologist (or Surgeon).
timeFrame: Prior to radiation, 4 weeks post RT, 6 months post RT, then yearly up to 10 1/2 years post RT
measure: Number of Participants will have Quality of Life Results Assessed by Utilizing the Breast Cancer Treatment Outcome Scale (BCTOS) using Patient Self Reports for Global Quality of Life.
timeFrame: Prior to radiation, 4 weeks post RT, 6 months post RT, then yearly up to 10 1/2 years
measure: Number of Participants will have Fatigue Results Assessed by Utilizing the Breast Cancer Treatment Outcome Score (BCTOS) using Patient Self Reports.
timeFrame: Prior to radiation, 4 weeks post RT, 6 months post RT, then yearly up to 10 1/2 years.
measure: Number of Participants will have Treatment Related Symptoms Assessed by Utilizing the Breast Cancer Treatment Outcome Scale (BCTOS) using Patient Self Reports.
timeFrame: Prior to radiation, 4 weeks post RT, 6 months post RT, then yearly up to 10 1/2 years
measure: Number of Participants will have Convenience of Care Assessed by Utilizing the Breast Cancer Treatment Outcome Scale (BCTOS) using Patient Self Reports
timeFrame: Prior to radiation, 4 weeks post RT, 6 months post RT, then yearly up to 10 1/2 years
Locations:
city: Harrisonburg
country: United States
facility: Sentara RMH Hahn Cancer Center
state: Virginia
Study officials:
affiliation: Sentara RMH Medical Center
name: Heather A. Morgan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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.