Tumor: Breast Ratio Study

NCT02216136 | Completed Results DMC

• 1 other identifier: 201404004
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer; LCIS; DCIS

Keywords

Mastectomy; Breast Cancer; Reconstruction; Lumpectomy; Breast Conservation Therapy

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Dolen U, Thornton M, Tenenbaum MM, Aripoli A, Patel A, Cyr AE, Yan Y, Appleton CM, Margenthaler JA, Myckatyn TM. A prospective cohort study to analyze the interaction of tumor-to-breast volume in breast conservation therapy versus mastectomy with reconstruction. Breast Cancer Res Treat. 2020 Jun;181(3):611-621. doi: 10.1007/s10549-020-05639-w. Epub 2020 Apr 30.

  PMID: 32350679 DERIVED

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Results Point of Contact

• Title: Terence M. Myckatyn, M.D.
• Organization: Washington University School of Medicine

myckatyn@wustl.edu

314-996-3873

Study Officials

• Terence M. Myckatyn, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: August 13, 2014
• Study Start: April 14, 2014
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: August 2, 2019
• Results First Posted: August 2, 2019

Record last verified: 2019-06

Locations

US (1)