Multi-scale Modeling of Breast Conserving Therapy

NCT02310711 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2018-10-10

No results posted yet for this study

Summary

The proposed study is a single-center, prospective, pilot, observation study to tabulate and measure the changes that occur during treatment and healing for breast conserving therapy (BCT) in women with non-metastatic breast cancer for comparison to the multiscale model of breast lumpectomy and healing in order to identify targets for improving BCT. The study will be comprised of 12 de novo breast cancer patients with non-metastatic breast cancer undergoing BCT. Subjects will be enrolled in the study during the 3 weeks prior to receiving their BCT surgery and will be followed for six months after the BCT surgery. A total of 6 visits (not including the surgery) are planned.

Conditions

Interventions

OTHER

Standard of Care

Standard of care for early stage breast cancer is breast conserving therapy at this center. Other concomitant standard of care treatment • Radiation therapy to the whole breast o 45-50 Gy delivered over 25-28 fractions with a boost to the tumor bed of 10-16 Gy delivered over 5-8 fractions

Sponsors & Collaborators

  • The Methodist Hospital Research Institute

    lead OTHER

Principal Investigators

  • Barbara Bass, MD · Chair, Department of Sugery

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02310711 on ClinicalTrials.gov