Clinical trial · Observational
Tumor: Breast Ratio Study
A Prospective Trial to Assess Tumor :Breast Ratio and Patient Satisfaction in Following Lumpectomy Versus Mastectomy With Reconstruction
NCT02216136CI-TRIAL-00039863T:BcompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an observational study of 3 arms: breast conservation therapy, mastectomy and reconstruction, and mastectomy only.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| DCIS | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
| LCIS | Breast Lobular Carcinoma In Situ | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Breast Conservation Cohort
- description
- Breast Conservation group (Group A) with newly diagnosed breast cancer who decide to proceed with lumpectomy and radiation treatment.
- label
- Mastectomy and Reconstruction Cohort
- description
- 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.
- label
- Mastectomy Only Cohort
- description
- Mastectomy Only Cohort: This group will have mastectomy without reconstruction. They may or may not require chemotherapy and radiation.
Primary outcomes (1)
- measure
- Quality of Life as Measured by the Breast Q
- timeFrame
- Compare preoperative values with postoperative values (up to 4 years)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 72 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDolen 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