Multi-scale Modeling of Breast Conserving Therapy

NCT02310711 | Unknown

• 3 other identifiers: Pro00006887IRB0112-0007BCTMM01
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

Breast; Mastectomy; Lumpectomy; Breast Therapy

Outcome Measures

Primary Outcomes (1)

• Study Endpoint

  The proportion of subjects with ≥60% agreement between the surgical/healing outcome of the lumpectomy and breast surface contour and the predicted changes from the multi-scale model.

  Six-month Post-Surgery

Interventions

Standard of Care OTHER

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

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with breast cancer who are having BCT and who satisfy the following criteria will be considered for participation in this study.

You may qualify if:

• Adult females ≥ age 30 years
• Have early stage (Stage I, II), non-metastatic breast cancer
• Planned to receive BCT
• Have received a pre-operative mammogram within 30 days of surgery
• Have received pre-operative magnetic resonance imaging (MRI) within 30 days of surgery
• Planned to receive post-surgery radiotherapy by whole breast radiotherapy
• Signed informed consent form prior to any research assessment

You may not qualify if:

• Adult females younger than 30 years of age
• Previous breast cancer
• Neo-adjuvant therapy for breast cancer
• Pregnant or nursing females
• Participation in a study of investigational drug in the previous 30 days or 5 half-lives of the investigational drug

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hopsital

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

• Salmon R, Garbey M, Moore LW, Bass BL. Interrogating a multifactorial model of breast conserving therapy with clinical data. PLoS One. 2015 Apr 23;10(4):e0125006. doi: 10.1371/journal.pone.0125006. eCollection 2015.

  PMID: 25906048 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Barbara Bass, MD

  Chair, Department of Sugery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda W. Moore

CONTACT

713-441-6144; lwmoore@houstonmethodist.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Surgery

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: December 8, 2014
• Study Start: May 1, 2012
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: October 10, 2018

Record last verified: 2018-10

Locations

US (1)