Tumor: Breast Ratio Study

Breast Cancer Clinical Trial

— T:B  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02216136
• Other study ID #: 201404004
• Status: Completed
• Start date: April 14, 2014
• Est. completion date: October 31, 2018

Study information

• Verified date: June 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 72 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• DCIS
• LCIS

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
•   This website allows for direct access to the West County Plastic Surgeons' web site.