Clinical trial NCT02022202: Breast Cancer Genome Guided Therapy Study (BEAUTY)
Official title: Breast Cancer Genome Guided Therapy Study (BEAUTY)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Invasive Breast Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-12-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary Care Clinic

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.


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.

Primary outcomes:
measure: DNA From the Germline and Breast Tumor for the Identification of Novel Somatic Changes Within Gene and Gene Pathways.
timeFrame: 1 year 3 months
measure: Frequency of Known Tumor Mutations for Which Current Drug Therapies Already Exist.
timeFrame: 1 year 3 months
measure: Association Between Breast Cancer Events and Patient-derived Xenografts (PDX) Engraftment
timeFrame: 1 year 3 months
measure: Somatic Alterations Identified Are Associated With Pathologic Complete Response to Therapy.
timeFrame: 1 year 3 months
Secondary outcomes:
measure: 99mTc-sestamibi Uptake and Pathologic Response Following Neoadjuvant Chemotherapy.
timeFrame: 1 year 3 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic campus in Arizona
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Matthew P. Goetz, M.D.
role: STUDY_CHAIR
affiliation: Mayo Clinic campus in Arizona
name: Donald W. Northfelt, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Judy C. Boughey, M.D.
role: PRINCIPAL_INVESTIGATOR
References: