NCT03674112 · OUTCOME

Number of Participants With Chemistry and Hematology Laboratory Test Result Shifts From NCI-CTCAE Grade 0-2 at Baseline to Grade 3-4 Post-Baseline During the Treatment Cross-Over and Treatment Continuation Periods

A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer · Source last updated 2024-01-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Pre-dose at Day 1 of Cycles 1 (baseline), 4, 7, 11, 15, and end of treatment (up to 18 cycles; 1 cycle is 21 days)

What was measured

Laboratory data for targeted chemistry and hematology parameters were classified according to the NCI CTCAE v4.0; Grade 0 is normal and Grades 1 to 4 represent worsening levels of the parameter outside of the normal range in the specified direction of the abnormality (high and low are above and below the range, respectively). The results show the shifts in the number of participants with Grade 0-2 at baseline to Grade 3-4 post-baseline; those with missing baseline values were counted as Grade 0-2 at baseline. Not every laboratory abnormality qualified as an adverse event, only if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment (e.g., dosage modification, treatment interruption, or treatment discontinuation); resulted in a medical intervention or a change in concomitant therapy; or, was clinically significant in the investigator's judgment. SGOT/AST = aspartate aminotransferase; SGPT/ALT = alanine aminotransferase

Analysis population: Safety Population: All participants who received at least one dose of any study treatment categorized according to the study treatment administered. In this analysis, participants are grouped by study arm and treatment received during the Cross-Over Period. The number analyzed (denominator) represents those with NCI-CTCAE Grade 0-2 at baseline and at least one post-baseline assessment.

Groups in this outcome

Arm A: Treatment With P+H IV (Cycles 1 to 3)

This safety analysis population only includes the safety data that was collected from Arm A participants during treatment Cycles 1 to 3 when all Arm A participants were treated with P+H IV. In the Treatment Cross-Over Period of the study, participants randomized to Arm A first received treatment with pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles and that was followed by treatment with pertuzumab and trastuzumab FDC SC (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days).

Arm A: Treatment With PH FDC SC (Cycles 4 to 6)

This safety analysis population only includes the safety data that was collected from Arm A participants during treatment Cycles 4 to 6 when all Arm A participants were treated with PH FDC SC. In the Treatment Cross-Over Period of the study, participants randomized to Arm A first received treatment with pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles and that was followed by treatment with pertuzumab and trastuzumab FDC SC (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days).

Arm B: Treatment With PH FDC SC (Cycles 1 to 3)

This safety analysis population only includes the safety data that was collected from Arm B participants during treatment Cycles 1 to 3 when all Arm B participants were treated with PH FDC SC. In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received treatment with pertuzumab and trastuzumab FDC SC (PH FDC SC) for 3 treatment cycles and that was followed by treatment with pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles (1 cycle = 21 days).

Arm B: Treatment With P+H IV (Cycles 4 to 6)

This safety analysis population only includes the safety data that was collected from Arm B participants during treatment Cycles 4 to 6 when all Arm B participants were treated with P+H IV. In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received treatment with pertuzumab and trastuzumab FDC SC (PH FDC SC) for 3 treatment cycles and that was followed by treatment with pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles (1 cycle = 21 days).

P+H IV: Treatment Continuation Period

This safety analysis population includes all participants from Arms A and B who, following completion of the Treatment Cross-Over Period, chose to receive pertuzumab IV and trastuzumab IV (P+H IV) during the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment).

PH FDC SC: Treatment Continuation Period

This safety analysis population includes all participants from Arms A and B who, following completion of the Treatment Cross-Over Period, chose to receive the pertuzumab and trastuzumab fixed-dose combination administered subcutaneously (PH FDC SC) during the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.