Metadata record for the manuscript: Abemaciclib as initial therapy for advanced breast cancer: MONARCH 3 updated results in prognostic subgroups

Summary

This metadata record provides details of the data supporting the claims of the related manuscript: “Abemaciclib as initial therapy for advanced breast cancer: MONARCH 3 updated results in prognostic subgroups Ye”.

The related Brief Communication reports data for clinically prognostic subgroups from MONARCH 3: liver metastases, progesterone receptor status, tumor grade, bone-only disease, ECOG performance status, and treatment-free interval (TFI) from an additional 12-month follow-up (after final progression-free survival [PFS] readout).

Subject of data: Homo sapiens

Sample size: 493 patients were randomised in MONARCH3. Power calculations and methods for analysing the primary and secondary endpoints were previously reported (https://doi.org/10.1038/s41523-018-0097-z). The study was powered to 80% at one-sided a = 0.025 assuming a hazard ratio of 0.67 in favour of the abemaciclib arm, with a final analysis at 240 progression-free survival events.

Population characteristics: Detailed study design and population were previously described. Eligible postmenopausal women were 18 years or older with locally tested HR-positive, HER2-negative locoregionally recurrent breast cancer not amenable to surgical resection or radiotherapy with curative intent or metastatic disease. Patients must have had measurable disease or nonmeasurable bone-only disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 and must not have received systemic therapy for advanced disease. Endocrine therapy in the neoadjuvant or adjuvant setting was permitted if the patient had a disease-free interval greater than 12 months from the completion of endocrine therapy.

Trial registration number: https://clinicaltrials.gov/ct2/show/NCT02246621

Data access

All data are contained in SAS files with the following names: adsl, adtte, adtte2, adtr, adrs. These files are housed on institutional storage and are not openly available in order to protect patient privacy. However, Eli Lilly and Company provides access to all individual participant data collected during the trial, after anonymisation, with the exception of pharmacokinetic or genetic data. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. For details on submitting a request, see the instructions provided at www.vivli.org: https://vivli.org/about/data-request-review-process/.

Corresponding author(s) for this study

Stephen Johnston, MA, FRCP, PhD, The Royal Marsden NHS Foundation Trust & The Institute of Cancer Research, Fulham Road, Chelsea, London, SW3 6JJ, UK. Tel +44 (0) 207-808-2748 (Chelsea) or +44 (0) 208-661-3861 (Sutton). Fax +44 (0) 207-808-2563; E-mail: stephen.johnston@rmh.nhs.uk

Study approval

The study was approved by the ethical and local institutional review boards for the sites participating in the clinical trial.