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

A Phase II Study of the Feasibility and Efficacy of Breast Conserving Surgery in Patients With MRI Detected Multi-Centric Breast Cancer

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.

Study Overview

• Status: Withdrawn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

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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ipsilateral breast tumor recurrence rates	Ipsilateral breast 6 months after diagnosis, bilateral annually for 5 years	5 years after completion of radiation
To determine the cosmetic outcome resulting from breast conserving surgery and breast radiation		at 1 year after radiation

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine if there are patient factors which limit a patient's suitability to receive breast conserving therapy	5 years after completion of radiation treatment
Patient satisfaction with the procedure as determined by a questionnaire	at 1 year after radiation
To evaluate wound healing and overall complication rate after radiation	at one year after radiation

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: William Chen, MD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: April 7, 2010
• First Submitted That Met QC Criteria: April 7, 2010
• First Posted (Estimate): April 9, 2010

Study Record Updates

• Last Update Posted (Estimate): December 8, 2011
• Last Update Submitted That Met QC Criteria: December 7, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Breast Diseases; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma, Ductal; Carcinoma in Situ; Breast Neoplasms; Carcinoma; Breast Carcinoma In Situ; Breast Neoplasms, Male; Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Lobular; Carcinoma, Ductal, Breast
• Other Study ID Numbers: CASE1109; NCI-2010-00644 (Other Identifier: NCI/CTRP)