Clinical trial NCT02216136: Tumor: Breast Ratio Study
Official title: A Prospective Trial to Assess Tumor :Breast Ratio and Patient Satisfaction in Following Lumpectomy Versus Mastectomy With Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
LCIS
DCIS
Keywords: Mastectomy
Breast Cancer
Reconstruction
Lumpectomy
Breast Conservation Therapy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2014-08-13
Enrollment: 162
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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


Eligibility criteria: 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

Primary outcomes:
measure: Quality of Life as Measured by the Breast Q
timeFrame: Compare preoperative values with postoperative values (up to 4 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Terence M. Myckatyn, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.