Breast Cancer Genome Guided Therapy Study (BEAUTY) (BEAUTY)

Tracking Information
First Submitted Date	December 20, 2013
First Posted Date	December 27, 2013
Last Update Posted Date	February 6, 2018
Actual Study Start Date	February 2013
Estimated Primary Completion Date	December 2018 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: December 20, 2013)	DNA from the germline and breast tumor for the identification of novel somatic changes within gene and gene pathways. [ Time Frame: 5 years ]To obtain DNA from the germline and breast tumor for the identification of novel somatic changes within gene and gene pathways that are potentially "druggable" in men or women with breast cancer undergoing a standard neoadjuvant paclitaxel (with or without trastuzumab), followed by a standard anthracycline containing regimen (e.g. doxorubicin and cyclophosphamide) for breast cancer.; Frequency of known tumor mutations for which current drug therapies already exist. [ Time Frame: 5 years ]To determine the frequency of known tumor mutations for which current drug therapies already exist (e.g. BRAF, C-KIT, EGFR mutation, KRAS, PTEN, PI3K).; Breast cancer tissue to develop tumor xenograft cell lines for mechanistic and functional studies. [ Time Frame: 5 years ]Using breast cancer tissue obtained prior to chemotherapy in all patients and following the completion of chemotherapy (in patients with residual tumors > 2 cm or residual nodal disease), to develop tumor xenograft cell lines for mechanistic and functional studies to determine whether mutations identified are associated with the malignant phenotype and response to associated drugs which target the gene and/or pathways.; Somatic alterations identified are associated with pathologic complete response to therapy. [ Time Frame: 5 years ]To determine whether somatic alterations identified above are associated with pathologic complete response to therapy.
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT02022202 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: December 20, 2013)	99mTc-sestamibi uptake and pathologic response following neoadjuvant chemotherapy. [ Time Frame: 5 years ]; Assess the association between changes in 99mTc-sestamibi uptake and pathologic response following neoadjuvant chemotherapy (MCR participants only).
Original Secondary Outcome Measures	Same as current
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Breast Cancer Genome Guided Therapy Study (BEAUTY)
Official Title	Breast Cancer Genome Guided Therapy Study (BEAUTY)
Brief Summary	The purpose of this research study is to better understand the reasons why or why not breast cancers are destroyed by standard chemotherapy. This information will be used to develop new and better cancer therapies.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Case-Only; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA; Description: Breast cancer tissue and blood specimens
Sampling Method	Probability Sample
Study Population	Primary Care Clinic
Condition	Invasive Breast Cancer
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Active, not recruiting
Estimated Enrollment; (submitted: December 20, 2013)	200
Original Estimated Enrollment	Same as current
Estimated Study Completion Date	December 2018
Estimated Primary Completion Date	December 2018 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion Criteria: Age ≥18 years.; Histological confirmation of invasive breast cancer.; Confirmation of breast cancer lesion ≥ 1.5 cm in size by any clinical (physical examination measurement) or radiographic criteria (mammogram, ultrasound or MRI) in the ipsilateral breast. Note: Benign breast disease, LCIS or DCIS in the contralateral breast is allowed. Contralateral invasive breast cancer is allowed if disease is of clinically lower stage and the higher stage lesion will be the study lesion for all biopsies and tissue samples. Note: Disease in axilla only is not eligible. Note: Patients that have a contraindication or inability to have an MRI may still be enrolled on study and not participate in the MRI at any of the study specific time points. Note: For patients with bilateral disease the higher clinical stage disease will be the study lesion that will undergo study biopsies and tissue samples from surgery and the contralateral lesion will NOT undergo research biopsies and tissue samples.; Men or women who are to begin neoadjuvant chemotherapy for treatment of Stage I-III Her 2 negative breast cancer with paclitaxel followed by either the combination of 5-fluorouracil, epirubicin and cyclophosphamide (FEC) or the combination of doxorubicin and cyclophosphamide (AC). OR Men or women who are to begin neoadjuvant chemotherapy for treatment of Stage I-III Her 2 positive breast cancer with paclitaxel followed by either the combination of 5-fluorouracil, epirubicin and cyclophosphamide (FEC) or the combination of doxorubicin and cyclophosphamide (AC). MC1137 Trastuzumab will be given concurrently with the taxane portion and can be given concurrently with FEC (but not AC) at the discretion of the medical oncologist. Note: Her2 positive disease is defined to be: HER2 score of 3+ by IHC or HER2 gene amplification by FISH.; Provide informed written consent.; Willing to return to Mayo Clinic in Rochester, MN, Mayo Clinic in Arizona, or Mayo Clinic in Florida for imaging correlative, surgery, and follow-up.; Willing to provide blood samples for correlative research purposes.; Willing to provide tissue samples for correlative research purposes.; ECOG Performance Status ≤ 2. Exclusion Criteria: Receiving any investigational agent which would be considered as a treatment for the primary neoplasm.; Other active malignancy ≤ 5 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. Note: If there is a history or prior malignancy, they must not be receiving any other treatment for their cancer.; Patients who are not planning to receive neoadjuvant chemotherapy.; Biopsy proven Stage IV disease.; Patients who are pregnant or nursing.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 99 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT02022202
Other Study ID Numbers	MC1137
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Mayo Clinic
Study Sponsor	Mayo Clinic
Collaborators	Not Provided
Investigators	Study Chair: Matthew P. Goetz, M.D. Mayo Clinic Principal Investigator: Donald W. Northfelt, M.D. Mayo Clinic campus in Arizona Principal Investigator: Judy C. Boughey, M.D. Mayo Clinic
PRS Account	Mayo Clinic
Verification Date	February 2018