Tumor: Breast Ratio Study

Study Overview
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Brief Summary
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This is an observational study of 3 arms: breast conservation therapy, mastectomy and reconstruction, and mastectomy only.

Official Title
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A Prospective Trial to Assess Tumor :Breast Ratio and Patient Satisfaction in Following Lumpectomy Versus Mastectomy With Reconstruction

Conditions
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LCIS, Breast Cancer, DCIS

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must be scheduled to undergo breast conservation therapy (BCT), mastectomy or mastectomy with immediate reconstruction (defined as initiating the reconstructive process at time of mastectomy) for ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), and early stage breast cancer (Clinical Stages IA-IIB). Stage IIB tumors are 2-5 cm with micrometastases 0.2 to 2.0 cm in lymph nodes; or 2-5 cm tumor with 1-3 positive axillary or internal mammary lymph nodes, or >5 cm with no lymph node involvement. Clinical staging, based on imaging and physical exam will be used for enrollment. Patients that are upstaged due to unexpected findings at the time of surgery/assessment of surgical pathology will be excluded at that time. For staging reference please see http://www.cancer.gov/cancertopics/pdq/treatment/breast/patient/page2#keypoint13 If multifocal/multicentric disease of the ipsilateral breast is encountered and patients are still deemed eligible for BCT or mastectomy per standard of care, then the tumor area will be calculated as the total volumes of the identified foci. Patient must be between 18-72 years old Patient must be able to understand and willing to sign a written informed consent document Exclusion Criteria: Cognitive impairment History of radiation to the chest wall or breasts Patients unable to undergo MRI due to metallic implant or claustrophobia Patients that are pregnant since breast MRI is contraindicated History of previous breast surgery other than primary cosmetic augmentation or breast reduction Identification of a concurrent or synchronous contralateral cancer during the enrollment period Any patient that would not have been considered for BCT or reconstruction BCT patients planning to proceed with reconstruction during their study participation timeline

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast Conservation Cohort<br>Breast Conservation group (Group A) with newly diagnosed breast cancer who decide to proceed with lumpectomy and radiation treatment. | |
| Mastectomy and Reconstruction Cohort<br>Mastectomy and Reconstruction group (Group B): This group will have mastectomy with immediate reconstruction (defined as reconstruction process starting at time of initial mastectomy surgery). They may or may not require chemotherapy and radiation depending on their cancer staging as well as multiple steps of their breast reconstruction. | |
| Mastectomy Only Cohort<br>Mastectomy Only Cohort: This group will have mastectomy without reconstruction. They may or may not require chemotherapy and radiation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life as Measured by the Breast Q | The Breast Q is a comprehensive and specific quality of life instrument that allows for patient self-assessment prior to and following breast surgery. Comprised of quality of life and satisfaction domains, and generates domain-specific Q-scores (0-100) constructed using Rasch analysis. The higher the score, the more satisfied the participant was. -Collected preoperatively (no more than 3 months prior to surgery) and postoperatively (approximately 6 months after conclusion of radiotherapy in the Breast Conservation Cohort and >=3 months after the final balancing reconstructive intervention in the Mastectomy and Reconstruction Cohort. | Compare preoperative values with postoperative values (up to 4 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mastectomy, Breast Cancer, Reconstruction, Lumpectomy, Breast Conservation Therapy