Partial Breast Radiation Therapy in Treating Women Undergoing Breast-Conserving Therapy for Early Stage Breast Cancer

NCT00527293 | Completed Early Phase 1 DMC

• 2 other identifiers: CASE2104P30CA043703
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 4

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. PURPOSE: This clinical trial is studying how well partial breast radiation therapy works in treating women undergoing breast-conserving therapy for early stage breast cancer.

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer; invasive ductal breast carcinoma; medullary ductal breast carcinoma with lymphocytic infiltrate; mucinous ductal breast carcinoma; tubular ductal breast carcinoma; papillary ductal breast carcinoma

Outcome Measures

Primary Outcomes (5)

• Cosmetic outcome as determined by an established scale employed by the radiation oncologist and the surgeon

  1 month after RT & Q3mos for one year

• Patient satisfaction with partial breast irradiation as measured by a questionnaire

  Pre-treatment 1 mo 3 mo 6 mo 9 mo 1yr 5 yr

• Wound healing and overall complication rate after partial breast irradiation

  1 month after RT & Q3mos for one year

• Determination of which patients are best suited for each individual technique of partial breast irradiation

  Patients will be followed for a period of five years following completion of radiation.

• Ipsilateral breast tumor recurrence rates and tumor bed recurrence rates

  Ipsilateral breast 6 mos after dx, bilateral annually x 5 years

Study Arms (2)

MammoSite Brachytherapy

EXPERIMENTAL

Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days

Procedure: adjuvant therapy; Radiation: brachytherapy

3-dimensional conformal radiotherapy

EXPERIMENTAL

3-dimensional conformal radiotherapy twice daily for 5-10 days.

Procedure: adjuvant therapy; Radiation: 3-dimensional conformal radiation therapy

Interventions

adjuvant therapy PROCEDURE

If chemotherapy is planned, it must begin no earlier than two weeks following completion of radiation. If chemotherapy is given first, a minimum of 2 weeks from the last cycle must elapse prior to the start of radiation.

3-dimensional conformal radiotherapy; MammoSite Brachytherapy

3-dimensional conformal radiation therapy RADIATION

3-dimensional conformal radiotherapy twice daily for 5-10 days.

3-dimensional conformal radiotherapy

brachytherapy RADIATION

Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days

MammoSite Brachytherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer, including the following histologic subtypes: * Invasive ductal carcinoma * Medullary ductal carcinoma * Papillary ductal carcinoma * Colloid (mucinous) ductal carcinoma * Tubular ductal carcinoma * The following histologic subtypes are not allowed: * Invasive lobular carcinoma * Extensive lobular carcinoma in situ * Ductal carcinoma in situ (DCIS) * Nonepithelial breast malignancies, such as lymphoma or sarcoma * No extensive intraductal component by Harvard definition (i.e., more than 25% of the invasive tumor is DCIS or DCIS present in adjacent tissue) * Stage I or II disease (T1, N0; T1, N1a; T2, N0; or T2, N1a) * Lesion ≤ 3 cm * No more than 3 positive lymph nodes * Patients with 4 or more positive axillary lymph nodes found at the time of axillary lymph node dissection/sentinel lymph node biopsy are not eligible * Has undergone tylectomy (lumpectomy) and axillary lymph node sampling (axillary node dissection or sentinel node biopsy) * Negative resection margins with ≥ 2 mm margin from invasive or in situ cancer OR a negative re-excision margin * Unifocal breast cancer * No multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by ≥ 4 cm) * No palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically confirmed negative * No skin involvement of disease * No Paget's disease of the nipple * No distant metastatic disease * Hormone-receptor status not specified PATIENT CHARACTERISTICS: * Female * Menopausal status not specified * Not pregnant or lactating * Negative pregnancy test * Fertile patients must use effective contraception for ≥ 1 week prior to, during, and for ≥ 2 weeks after completion of study treatment * No collagen vascular disorders, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis * No psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent * No other malignancy within the past 5 years, except non-melanomatous skin cancer PRIOR CONCURRENT THERAPY: * No prior radiotherapy to the breast * No chemotherapy for at least 2 weeks before and 2 weeks after completion of study radiotherapy * Concurrent hormonal therapy allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Lake/University Ireland Cancer Center

Cleveland, Ohio, 44060, United States

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

UHHS Chagrin Highlands Medical Center

Cleveland, Ohio, 44122, United States

Location

UHHS Westlake Medical Center

Cleveland, Ohio, 44145, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Ductal, Breast

Interventions

Chemotherapy, Adjuvant; Radiotherapy, Conformal; Brachytherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy, Computer-Assisted; Radiotherapy

Study Officials

• Janice Lyons, MD

  Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2007
• First Posted: September 10, 2007
• Study Start: June 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: February 1, 2015
• Last Updated: August 25, 2015

Record last verified: 2015-08

Locations

US (4)