Breast-Conserving Surgery Followed by Radiation Therapy With MRI-Detected Stage I or Stage II Breast Cancer - Full Text View

Sponsor:	Case Comprehensive Cancer Center
Information provided by (Responsible Party):	Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT01100489

Purpose

RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II clinical trial is studying how well breast-conserving surgery followed by radiation therapy works in treating patients with stage I or stage II breast cancer.

Condition	Intervention	Phase
Ductal Breast Carcinoma in Situ Estrogen Receptor-negative Breast Cancer Estrogen Receptor-positive Breast Cancer HER2-negative Breast Cancer HER2-positive Breast Cancer Invasive Ductal Breast Carcinoma Invasive Lobular Breast Carcinoma Male Breast Cancer Medullary Ductal Breast Carcinoma With Lymphocytic Infiltrate Mucinous Ductal Breast Carcinoma Papillary Ductal Breast Carcinoma Progesterone Receptor-negative Breast Cancer Progesterone Receptor-positive Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Tubular Ductal Breast Carcinoma	Radiation: external beam radiation therapy Other: questionnaire administration Procedure: therapeutic conventional surgery	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of the Feasibility and Efficacy of Breast Conserving Surgery in Patients With MRI Detected Multi-Centric Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Male Breast Cancer

U.S. FDA Resources

Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:

Ipsilateral breast tumor recurrence rates [ Time Frame: 5 years after completion of radiation ] [ Designated as safety issue: No ]
Ipsilateral breast 6 months after diagnosis, bilateral annually for 5 years
To determine the cosmetic outcome resulting from breast conserving surgery and breast radiation [ Time Frame: at 1 year after radiation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine if there are patient factors which limit a patient's suitability to receive breast conserving therapy [ Time Frame: 5 years after completion of radiation treatment ] [ Designated as safety issue: No ]
Patient satisfaction with the procedure as determined by a questionnaire [ Time Frame: at 1 year after radiation ] [ Designated as safety issue: No ]
To evaluate wound healing and overall complication rate after radiation [ Time Frame: at one year after radiation ] [ Designated as safety issue: Yes ]

Enrollment:	0
Study Start Date:	February 2010
Study Completion Date:	October 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I Patients undergo breast-conserving surgery consisting of partial mastectomies followed by external beam breast radiation therapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.	Radiation: external beam radiation therapy External beam breast radiation therapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity. Other Name: EBRT Other: questionnaire administration Ancillary studies: The patient will complete the Cosmesis /QOL form (Appendix II) and the treating physician will complete the Cosmetic Guidelines (skin assessment) form for baseline data (Appendix I). Procedure: therapeutic conventional surgery Patients will undergo excisional biopsy or needle localization removal of the tumor. Patients with margins < 2 mm undergo re-excision of the biopsy cavity. Surgical clips should be placed at the time of tylectomy to define the excision cavities. Ideally, clips are to be placed marking the superficial, deep, right, left, inferior, and superior dimensions of the tylectomy or re-excision cavities.

Arms

Assigned Interventions

Experimental: Arm I

Patients undergo breast-conserving surgery consisting of partial mastectomies followed by external beam breast radiation therapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.

Radiation: external beam radiation therapy

External beam breast radiation therapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.

Other Name: EBRT

Other: questionnaire administration

Ancillary studies: The patient will complete the Cosmesis /QOL form (Appendix II) and the treating physician will complete the Cosmetic Guidelines (skin assessment) form for baseline data (Appendix I).

Procedure: therapeutic conventional surgery

Patients will undergo excisional biopsy or needle localization removal of the tumor. Patients with margins < 2 mm undergo re-excision of the biopsy cavity. Surgical clips should be placed at the time of tylectomy to define the excision cavities. Ideally, clips are to be placed marking the superficial, deep, right, left, inferior, and superior dimensions of the tylectomy or re-excision cavities.

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine ipsilateral breast tumor recurrence rates as well as tumor bed recurrence rates. Patients will be followed for a period of five years following completion of radiation to determine these rates.

II. To determine the cosmetic outcome resulting from breast conserving surgery and breast radiation.

SECONDARY OBJECTIVES:

I. To determine if there are patient factors which limit a patient's suitability to receive breast conserving therapy in the setting of multi-centric disease.

II. To determine patient satisfaction of breast conserving therapy as it pertains to their overall treatment experience as measured by a questionnaire.

III. To evaluate wound healing and overall complication rate after radiation as a component of breast conserving therapy.

OUTLINE:

Patients undergo breast-conserving surgery consisting of partial mastectomies followed by external beam breast radiation therapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 1 month, then every 3 months for 1 year, every 6 months for 1 year, and then annually for 5 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion

Patients with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm)
All radiographically suspicious lesions must be biopsied and have histologically confirmed ductal carcinoma in-situ, invasive ductal, invasive lobular, medullary, papillary, colloid (mucinous), or tubular histologies
A maximum of two radiographically detected malignant lesions
Clinical Stage I-II breast carcinoma, with lesion size =< 5 cm for the dominant mass and the second lesion detected only on MRI, treated with lumpectomies; the MRI detected lesion must be pathologically =< 1 cm
Axillary lymph node evaluation, either sentinel lymph node biopsy or axillary dissection as deemed appropriate by the treating surgeon for all patients with invasive cancer; no axillary lymph node sampling is needed for patients with DCIS
Negative resection margins with at least a 2 mm margin from invasive and in-situ cancer or a negative re-excision
A posterior margin =< 2 mm from DCIS is permissible provided fascia was taken
Patients are eligible regardless of estrogen receptor, progesterone receptor, or Her-2/neu amplification
Hormonal therapy is allowed; if adjuvant chemotherapy is planned, the chemotherapy should be delivered first and radiation must begin no earlier than three weeks and no later than eight weeks following completion of chemotherapy
Signed study-specific informed consent prior to study entry

Exclusion

Extensive intraductal component by the Harvard definition (i.e., more than 25% of the invasive tumor is DCIS and DCIS present in adjacent breast tissue)
Palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically confirmed negative
Patients receiving neoadjuvant chemotherapy
Patients with distant metastatic disease detected by radiographic imaging; specific studies for systemic imaging should be obtained as directed by localized symptoms or per available NCCN guidelines
Patients with known BRCA 1/BRCA 2 mutations or those with predicted risk of carrying the mutation by BRCAPRO (44) risk assessment >= 50%
Diffuse calcifications throughout the breast
Patients with skin involvement or inflammatory breast cancer
Patients with Paget's disease of the nipple
Patients nonepithelial breast malignancies such as lymphoma or sarcoma
Patients with collagen vascular disorders, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis
Patients with psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent
Other malignancy, except non-melanomatous skin cancer, < 5 years prior to participation in this study
Patients who are pregnant or lactating, due to potential fetal exposure to radiation and unknown effects of radiation on lactating females

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100489

Locations

United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
UH-Chagrin Highlands
Orange Village, Ohio, United States, 44122
UH-Westlake
Westlake, Ohio, United States, 44145

Sponsors and Collaborators

Case Comprehensive Cancer Center

Investigators

Principal Investigator:

William Chen, MD

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

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT01100489 History of Changes
Other Study ID Numbers:	CASE1109, NCI-2010-00644
Study First Received:	April 7, 2010
Last Updated:	December 7, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Breast Neoplasms
Carcinoma
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Carcinoma, Lobular
Breast Neoplasms, Male
Neoplasms by Site

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

ClinicalTrials.gov processed this record on May 23, 2012