Metadata record for the article: Phase 1b clinical trial of ado-trastuzumab emtansine and ribociclib for HER2-positive metastatic breast cancer

<b>Summary</b><br>

This
metadata record provides details of the data supporting the claims of the
related article: “Phase 1b clinical trial of
ado-trastuzumab emtansine and ribociclib for HER2-positive metastatic breast
cancer”.

The
related study reports the results of an open-label, phase Ib clinical trial
designed to assess the safety, tolerability, and activity of ribociclib in
combination with T-DM1 among women with metastatic or locally advanced HER2+
breast cancer.

Type of data:
clinical data; pharmacokinetic (PK) data

Subject of
data: <i>Homo sapiens</i>

Sample size:
12

Population
characteristics: one cohort of ribociclib in combination with T-DM1 (cohort A—2
other cohorts from the same trial are reported elsewhere); Pre- and
post-menopausal women aged 18 years or older with histologically confirmed
unresectable, locally advanced, or metastatic HER2+ breast cancer and measurable
or non-measurable disease according to Response Evaluation Criteria in Solid
Tumor (RECIST) 1.1

Trial
registration number: NCT02657343

<b>Data
access</b>

All data are
stored in the following files: Excel files ‘Figure 1’, ‘Figure 2’, ‘Figure 3’,
‘Table 1’, ‘Table 2’; Word file: ‘Supplement TDM1 Ribo Manuscript_revision.docx’.
The Excel files are housed on institutional file storage and are not publicly
available in order to protect patient privacy as informed consent to share
participant-level data was not obtained prior to or during data collection.
However, the data can be made available upon request to the corresponding
author. The Word file is shared publicly via this data record, and is also
available in PDF format as part of the supplementary materials of the related
article.

<b>Corresponding author(s) for this study</b>

Aditya
Bardia MD, MPH, Attending Physician, Massachusetts General Hospital Cancer
Center, Harvard Medical School, Bartlett Hall, 15 Parkman St., Boston, MA 02114.
Office: [phone]; Fax: [phone]. Email:
[e-mail]<br>
<br>
<b></b>

<b>Study
approval </b>

The
study received institutional review board (IRB) approval from the
Dana-Farber/Harvard Cancer Center Human Research Committee.