Evaluation of Accelerated Partial Breast Brachytherapy

Breast Cancer Clinical Trial

Official title:

Evaluation of Accelerated Partial Breast Brachytherapy as the Sole Method of Radiation Therapy for Stage 0, 1 and II Lymph Node Negative Breast Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00593346
• Other study ID #: 03-1205 / 201011816
• Status: Completed
• Phase: N/A
• First received: January 2, 2008
• Last updated: June 1, 2015
• Start date: March 2004
• Est. completion date: November 2013

Study information

• Verified date: June 2015
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Over the past two decades, breast conserving therapy (BCT) has become a major treatment modality for Stage I and II breast carcinoma. The major advantages of breast conserving therapy are superior cosmetic outcome and the reduced emotional and psychological trauma afforded by this procedure compared with conventional mastectomy. The principal disadvantage of BCT is its more complex and prolonged treatment regimen requiring approximately 6 weeks of external beam radiation therapy that poses problems for some patients such as the working woman, elderly patients, and those who live at a significant distance from a treatment center. These factors, along with the patient's geographic location, result in a smaller fraction of the patients who currently meet eligibility criteria for BCT actually receiving it, despite its cosmetic and probable psychological advantages. The logistical problems of BCT are primarily related to the protracted course of external beam radiation therapy to the whole breast. While some investigators reported what they believe to be acceptable local control rates in carefully selected patients treated by wide local excision without radiation therapy, the criteria for patient selection are controversial and poorly defined and probably restrict the access of many patients to breast conserving therapy.

If previous observations are valid and breast irradiation following tylectomy exerts its maximal effect in eradicating occult disease remaining in the immediate vicinity of the tylectomy site, can radiation therapy be directed only to the tissue surrounding the excision cavity of the breast, using brachytherapy alone? If so, the entire course of radiation therapy could be delivered over a 4 to 7 day period immediately following tylectomy and/or axillary dissection, thus markedly reducing treatment time. Brachytherapy also inherently provides a higher central dose to the volume most at risk for recurrence. Cosmetic outcome after the use of a brachytherapy boost after external whole breast radiotherapy is comparable or slightly inferior to electron beam boost radiation therapy

Description:

This study will evaluate the local control, cosmetic results, quality of life, and complication rates of brachytherapy when used as the sole method of radiation therapy for patients with stage 0,I, and II carcinoma of the breast treated with tylectomy, with histologically assessed negative surgical margins, N0 axillary nodes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• AJCC stage 0, I, or II (TisN0, T1N0, T2N0 = 3 cm) histologically confirmed carcinoma of the breast, treated with tylectomy. Axillary sampling is required only for cases of invasive cancers. Tumor size is determined by the pathologist. Clinical size may be used if the pathologic size is indeterminate.

• Signed study-specific informed consent for participation in the study.

• Negative, or close but negative, inked histologic margins of tylectomy or reexcision specimen to be confirmed prior to placing the brachytherapy catheters. Margins generally are positive if there is invasive or noninvasive tumor at the inked resection margin, close but negative if the tumor is within 2 mm of the inked margin and negative if the tumor is at least 2 mm away from the inked edge.

• Negative post-tylectomy or post-reexcision mammography if cancer presented with malignancy-associated microcalcifications; no remaining suspicious microcalcifications in the breast before brachytherapy.

• For patients with invasive cancer, no positive axillary lymph nodes with at least 6 axillary lymph nodes sampled or a negative sentinel node.

• Invasive ductal, lobular, medullary, papillary, colloid (mucinous),or tubular histologies. Noninvasive ductal carcinoma in situ.

• Chemotherapy or hormonal therapy planned for = 2 weeks after removal of brachytherapy catheters is permitted. Hormonal therapy is allowed during brachytherapy at treating radiation oncologist's decision.

• Negative pregnancy test for premenopausal patients with an intact uterus

Exclusion Criteria:

• Patients with distant metastases.

• Patients with in-situ lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma.

• Patients with proven multicentric carcinoma (tumors in different quadrants of the breast, or tumors separated by at least 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy.

• Patients who are pregnant or lactating.

• Patients with histologically confirmed positive axillary nodes in the ipsilateral axilla. Palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.

• Prior non-hormonal therapy for the present breast cancer, including radiation therapy or chemotherapy.

• Patients with systemic lupus erythematosis, scleroderma, or dermatomyositis with a CPK level above normal or with an active skin rash.

• Patients with coexisting medical conditions in whom life expectancy is < 2 years.

• Patients with psychiatric or addictive disorders that would preclude obtaining informed consent or completing the full series of high dose rate brachytherapy treatments on an outpatient basis.

• Patients with Paget's disease of the nipple.

• Patients with skin involvement, regardless of tumor size.

• Patients with a breast unsatisfactory for brachytherapy. For example, if there is little breast tissue remaining between the skin and pectoralis muscle after surgery, placement of catheters is technically problematic.

• Patients with tylectomies so extensive that the cosmetic result is fair or poor prior to brachytherapy.

• Surgical margins which cannot be microscopically assessed or are positive at pathological evaluation.

• Any previously treated contralateral breast carcinoma or synchronous bilateral breast carcinoma.

• Other malignancy, except non-melanoma skin cancer, = 5 years prior to participation in this study; the disease free interval from any prior carcinoma must be continuous.

• Time between final definitive breast procedure to radioactive source loading of the brachytherapy catheters is greater than 8 weeks.

• Patients with diffuse (> 1 quadrant or >5 cm in diameter) suspicious microcalcifications.

• Patients with suspicious microcalcifications remaining on the post-tylectomy mammogram

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Radiation:
• brachytherapy
brachytherapy (radioactive implants)

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Control Using Ipsilateral Breast Tumor Recurrence Rates		2 years after treatment completion	No
Primary	Local Control as Measured by Ipsilateral Breast Tumor Recurrence Rates		5 years after treatment completion	No
Primary	Local Control Using Disease-free Survival Rates		2 years after treatment completion	No
Primary	Local Control Using Disease-free Survival Rates		5 years after treatment completion	No
Secondary	Quality of Life Completion	-QOL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and EORTC breast cancer module QLQ-BR23 questionnaires. QLQ-C30 is composed of 30 questions. QLQ-BR23 consists of 23 questions.	2 years	No
Secondary	Excellent-good Cosmetic Outcomes - Patient Reported	Both the participants and the treating radiation oncologist qualitatively rated cosmesis as excellent, good, fair, or poor over time and ascribed a cause for changes in cosmesis.; The global cosmetic result were scored on a 4-point scare where 0=excellent result (no difference), 1=good (small difference), 2=fair result (moderate difference) and 3=poor result (large difference).	3 years after completion of therapy	No
Secondary	Excellent-good Cosmetic Outcomes - Physician Reported	Both the participants and the treating radiation oncologist qualitatively rated cosmesis as excellent, good, fair, or poor over time and ascribed a cause for changes in cosmesis. Cosmetic outcome was evaluated quantitatively by percentage of breast retraction assessment (pBRA).; The global cosmetic result were scored on a 4-point scale where 0=excellent result (no difference), 1=good (small difference), 2=fair result (moderate difference) and 3=poor result (large difference).	3 years after completion of therapy	No
Secondary	Impressions of the Cause of Cosmesis Changes Over Time - Patient Reported	-Patients filled out a form "Patient Evaluation of the Treated Breast". On this form the patients were asked to compare the memory of what their breast looked like after surgery but before radiation and to compare that memory to the appearance of the breast after radiation. The patients were then asked if their breast changes were due to: caused mostly by radiation; caused by both the radiation and surgery, but mostly by the radiation; caused by both the radiation and surgery, but mostly by the surgery; caused mostly by the surgery; can't judge which treatment caused the change; there are no changes	3 years	No
Secondary	Cosmesis Outcome as Measured by Percentage of Breast Retraction Assessment (pBRA)	-Cosmetic outcome was evaluated quantitatively by percentage of breast retraction assessment (pBRA)	Pre-treatment and 3 years	No
Secondary	Presence or Absence of Complications	As defined by number of participants who experienced breast infection and symptomatic fat necrosis.	5 years after treatment completion	Yes
Secondary	Occurrence of Mastectomy After Completion of Initial Breast-conserving Treatment		5 years after treatment completion	No
Secondary	Frequency of Grade 3-4 Toxicities	RTOG acute and late toxicity grading system and via a visual analog scale for pain assessment.	Up to 1 year from completion of therapy	Yes

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine