Metadata record for the article: Circulating tumor cell number and endocrine therapy index in ER positive metastatic breast cancer patients
Creators: name: Paoletti, Costanza
name: Regan, Meredith M.
name: Niman, Samuel M.
name: Dolce, Emily M.
name: Darga, Elizabeth P.
name: Minetta C. Liu
name: P. Kelly Marcom
name: Hart, Lowell L.
name: Smith, John W.
name: Tedesco, Karen L.
name: Amir, Eitan
name: Krop, Ian E.
name: DeMichele, Angela M.
name: Goodwin, Pamela J.
name: Block, Margaret
name: Aung, Kimberly
name: Brown, Martha E.
name: McCormack, Robert T.
name: Hayes, Daniel F.
Publisher: name: figshare
Year: 2021
Subjects: subject: 69999 Biological Sciences not elsewhere classified
subject: FOS: Biological sciences
subject: FOS: Biological sciences
subject: 119999 Medical and Health Sciences not elsewhere classified
subject: FOS: Other medical sciences
subject: FOS: Other medical sciences
subject: Cancer
subject: 111299 Oncology and Carcinogenesis not elsewhere classified
subject: FOS: Clinical medicine
subject: FOS: Clinical medicine
subject: Biomarkers
subject: Diseases

description: <b>Summary</b><br> This metadata record provides details of the data supporting the claims of the related article: “Circulating tumor cell number and endocrine therapy index in ER positive metastatic breast cancer patients”. The related study reports the results of the prospective, multi-institutional COMETI trial (P2-2012.0; NCT01701050), which was designed to test the hypothesis that circulating tumour-cell endocrine therapy index (CTC-ETI) could identify a subset of patients with estrogen receptor (ER) positive, HER2 negative metastatic breast cancer (MBC) who might have endocrine therapy (ET)-refractory disease and would be better treated with chemotherapy. Type of data: clinical data; CTC enumeration data/time point; phenotyping of the CTC (ER, BCL2, HER2, and Ki67), which were combined with the CTC enumeration to generate a “CTC-endocine therapy index” for each time point Subject of data: <i>Homo sapiens; </i>antibodies Population characteristics: patients had ER positive breast cancer, either in their primary or metastatic tumours Recruitment: Female subjects 18 years or older with ER positive, HER2 negative, progressive MBC after one or more lines of ET who are initiating a new ET were enrolled into the study. Subjects must have immunohistochemistry (IHC) proven ER positive disease, IHC and/or fluorescence in-situ hybridization (FISH) proven HER2 negative disease, and an ECOG performance status of 0-2. Subjects with brain metastases only or those who are progressing on fulvestrant were not eligible for the study. Trial registration number: NCT01701050 <b>Data access</b> The clinical outcomes data are not publicly available for the following reason: data contain information that could compromise research participant privacy. The CTC enumeration data/time point data and the CTC-endocine therapy index data have not been made openly available, but they are available upon request to the corresponding author. <b>Corresponding author(s) for this study</b> Dr. Daniel F. Hayes, Department of Internal Medicine, Division of Hematology/Oncology, University of Michigan Rogel Cancer Center, 6312 Rogel Cancer Center, 1500 E. Medical Center Drive Ann Arbor, MI 48109 USA. Telephone: +1 734-615-6725. Fax: +1 734-232-5913. hayesdf@umich.edu. <br> <b>Study approval </b> The study was approved by the Institutional Review Board of each participating center, and all the enrolled patients provided written informed consent in accordance with the Declaration of Helsinki.