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

NCT01100489 | Withdrawn Phase 2 DMC

• 2 other identifiers: CASE1109NCI-2010-00644
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (1)

Arm I

EXPERIMENTAL

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; Other: questionnaire administration; Procedure: therapeutic conventional surgery

Interventions

external beam radiation therapy RADIATION

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

Also known as: EBRT

Arm I

questionnaire administration OTHER

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).

Arm I

therapeutic conventional surgery PROCEDURE

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.

Arm I

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (3)

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

Cleveland, Ohio, 44106, United States

Location

UH-Chagrin Highlands

Orange, Ohio, 44122, United States

Location

UH-Westlake

Westlake, Ohio, 44145, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Ductal, Breast; Carcinoma, Lobular; Breast Neoplasms, Male; Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• William Chen, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2010
• First Posted: April 9, 2010
• Study Start: February 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 8, 2011

Record last verified: 2011-12

Locations

US (3)