Tumor: Breast Ratio Study (T:B)

The Washington University

Status: Completed

Conditions: Breast Cancer; LCIS; DCIS

Study type: Observational

Funder types: Other

Identifiers

NCT02216136

201404004

Details and patient eligibility

About

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

Enrollment: 162 patients

Sex: Female

Ages: 18 to 72 years old

Volunteers: No Healthy Volunteers

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

Trial design

162 participants in 3 patient groups

Breast Conservation Cohort

Description:

Breast Conservation group (Group A) with newly diagnosed breast cancer who decide to proceed with lumpectomy and radiation treatment.

Mastectomy and Reconstruction Cohort

Description:

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

Description:

Mastectomy Only Cohort: This group will have mastectomy without reconstruction. They may or may not require chemotherapy and radiation.