Breast Cancer Genome Guided Therapy Study (BEAUTY)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02022202
First received: December 20, 2013
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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.


Condition
Invasive Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Breast Cancer Genome Guided Therapy Study (BEAUTY)

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • DNA from the germline and breast tumor for the identification of novel somatic changes within gene and gene pathways. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To determine whether somatic alterations identified above are associated with pathologic complete response to therapy.


Secondary Outcome Measures:
  • 99mTc-sestamibi uptake and pathologic response following neoadjuvant chemotherapy. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Assess the association between changes in 99mTc-sestamibi uptake and pathologic response following neoadjuvant chemotherapy (MCR participants only).


Biospecimen Retention:   Samples With DNA

Breast cancer tissue and blood specimens


Estimated Enrollment: 200
Study Start Date: February 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary Care Clinic

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02022202

Locations
United States, Arizona
Mayo Clinic campus in Arizona
Scottsdale, Arizona, United States, 85259
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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
  More Information

No publications provided

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT02022202     History of Changes
Other Study ID Numbers: MC1137
Study First Received: December 20, 2013
Last Updated: April 28, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 15, 2014