search
Back to results

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

Primary Purpose

Ductal Breast Carcinoma in Situ, Estrogen Receptor-negative Breast Cancer, Estrogen Receptor-positive Breast Cancer

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
external beam radiation therapy
questionnaire administration
therapeutic conventional surgery
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ductal Breast Carcinoma in Situ

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  • UH-Chagrin Highlands
  • UH-Westlake

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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.

Outcomes

Primary Outcome Measures

Ipsilateral breast tumor recurrence rates
Ipsilateral breast 6 months after diagnosis, bilateral annually for 5 years
To determine the cosmetic outcome resulting from breast conserving surgery and breast radiation

Secondary Outcome Measures

To determine if there are patient factors which limit a patient's suitability to receive breast conserving therapy
Patient satisfaction with the procedure as determined by a questionnaire
To evaluate wound healing and overall complication rate after radiation

Full Information

First Posted
April 7, 2010
Last Updated
December 7, 2011
Sponsor
Case Comprehensive Cancer Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01100489
Brief Title
Breast-Conserving Surgery Followed by Radiation Therapy With MRI-Detected Stage I or Stage II Breast Cancer
Official Title
A Phase II Study of the Feasibility and Efficacy of Breast Conserving Surgery in Patients With MRI Detected Multi-Centric Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Withdrawn
Why Stopped
No accrual
Study Start Date
February 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
external beam radiation therapy
Other Intervention Name(s)
EBRT
Intervention Description
External beam breast radiation therapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ipsilateral breast tumor recurrence rates
Description
Ipsilateral breast 6 months after diagnosis, bilateral annually for 5 years
Time Frame
5 years after completion of radiation
Title
To determine the cosmetic outcome resulting from breast conserving surgery and breast radiation
Time Frame
at 1 year after radiation
Secondary Outcome Measure Information:
Title
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
Title
Patient satisfaction with the procedure as determined by a questionnaire
Time Frame
at 1 year after radiation
Title
To evaluate wound healing and overall complication rate after radiation
Time Frame
at one year after radiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Chen, MD
Organizational Affiliation
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
UH-Chagrin Highlands
City
Orange Village
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
UH-Westlake
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States

12. IPD Sharing Statement

Links:
URL
http://clinicaltrials.gov/ct2/show/NCT01100489?term=NCT01100489&rank=1
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs