Metadata record for the article: NRG Oncology/NSABP B-47 Menstrual History Study: Impact of Adjuvant Chemotherapy with and without Trastuzumab

This metadata record provides details of the data supporting the claims of the related article: “NRG Oncology/NSABP B-47 Menstrual History Study: Impact of Adjuvant Chemotherapy with and without Trastuzumab.”

The aims of the related study were to assemble an observational cohort of pre/perimenopausal women to evaluate the effect of trastuzumab on treatment-related amenorrhea (TRA) and the associations between TRA and circulating reproductive hormone levels. This data record is associated with an article, which is a secondary publication from the main trial. The primary publication of the main trial is https://doi.org/10.1200/JCO.19.01455.

Type of data: clinical data; multi-center randomized trial of chemotherapy with and without trastuzumab.

Subject of data: Women with an intact uterus; at least one ovary; at least one menstrual period in the past 12 months; no use of current oral contraceptive hormones or other hormone replacement therapy.

Sample size: 1,458 women enrolled in this study of whom 1,231 consented to baseline blood samples.

Population characteristics: Mean age of participants was 44.1 years. 81.5% were White, 90.5% were Non-hispanic, and 86.1% were estrogen-receptor and/or progesterone-receptor positive.

Recruitment: Eligible women were enrolled in the B-47 MH substudy upon random assignment to the parent trial.

Date of data collection: Participants enrolled from February 8, 2011 to February 10, 2015; Menstrual history assessed through 36 months of follow-up.

Geographic location: Multi-center trial in USA, Canada, and Ireland.

Trial registration number: https://clinicaltrials.gov/ct2/show/NCT01275677

The data generated in this study are gathered in csv format with file name B47MHSubstudy.csv.

This data file will be available from the NCTN/NCORP Data Archive repository one year after publication of the related article. This in accordance with the policy of the National Cancer Institute (https://nctn-data-archive.nci.nih.gov/).

After the embargo period the data file will be made available to researchers who wish to analyze the data in secondary studies to enhance the public health benefit of the original work. Data access requirements may include (but not be limited to): a research plan and a Data Use Agreement (DUA), with legally binding signatures.

Reena Cecchini (CecchiniR@nrgoncology.org)

Patricia Ganz (PGanz@mednet.ucla.edu)

Study approval

This multi-center trial was approved by the National Cancer Institute's Central Institutional Review Board (CIRB) and/or local human investigations committees or institutional review boards at institutions participating in this multi-center trial in accordance with National Cancer Institute policies and procedures, with assurances filed with and approved by the Department of Health and Human Services. Written informed consent was required for participation.