Tumor: Breast Ratio Study (T:B)

June 13, 2019 updated by: Washington University School of Medicine

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

162

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 72 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Females ages 18 - 72 years of age scheduled to undergo breast conservation therapy (BCT), mastectomy or mastectomy with immediate reconstruction for ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), and early stage breast cancer (Clinical Stages IA-IIB).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Breast Conservation Cohort
Breast Conservation group (Group A) with newly diagnosed breast cancer who decide to proceed with lumpectomy and radiation treatment.
Mastectomy and Reconstruction Cohort
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
Mastectomy Only Cohort: This group will have mastectomy without reconstruction. They may or may not require chemotherapy and radiation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life as Measured by the Breast Q
Time Frame: Compare preoperative values with postoperative values (up to 4 years)

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Terence M. Myckatyn, M.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2014

Primary Completion (Actual)

October 31, 2018

Study Completion (Actual)

October 31, 2018

Study Registration Dates

First Submitted

August 4, 2014

First Submitted That Met QC Criteria

August 11, 2014

First Posted (Estimate)

August 13, 2014

Study Record Updates

Last Update Posted (Actual)

August 2, 2019

Last Update Submitted That Met QC Criteria

June 13, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201404004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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