A Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer

Up to approximately 28 months

Up to approximately 7.8 months

EORTC QLQ-C30 is a cancer-specific instrument consisting of 30 questions used to assess the HRQoL in cancer participants.
First 28 questions evaluated 5 aspects of participant functioning (physical, emotional, role, cognitive, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).
These questions used a 4-point scale, with scores ranging from 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much).
The last 2 questions represented the participant's assessment of global health status (GHS) and quality of life (QoL), using a 7-point scale with scores ranging from 0-7 (1=very poor to 7=excellent).
EORTC QLQ-C30 scores were linearly transformed on a scale of 0 - 100, with a high score indicating better GHS/QOL.
Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement.

EORTC QLQ-C30=cancer-specific instrument consisting of 30 questions that evaluated 5 aspects of participant functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting & pain), global health status/quality of life (GHS/QoL) & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties).
Functioning & symptom items used a 4-point scale, scores ranging from 1=Not at all to 4=Very much.
GHS/QoL questions used a 7-point scale, scores ranging from 1=Very poor to 7=Excellent.
All EORTC scales & single-item measures were linearly transformed to a score range of 0-100.
High score for functional/GHS scale=high/healthy level of functioning/better HRQoL & high score for symptom scale=high level of symptom severity.
A positive change from baseline=improvement & negative change=worsening in QoL & functioning scales.
A positive change from baseline=deterioration & negative change=improvement in symptom scales.

EORTC QLQ-C30 is a cancer-specific instrument consisting of 30 questions used to assess the HRQoL in cancer participants.
First 28 questions evaluated 5 aspects of participant functioning (physical, emotional, role, cognitive, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).
These questions used a 4-point scale, with scores ranging from 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much).
The last 2 questions represented the participant's assessment of GHS/QoL, using a 7-point scale with scores ranging from 0-7 (1=very poor to 7=excellent).
EORTC QLQ-C30 scores were linearly transformed on a scale of 0 - 100, with a high score indicating better GHS/QOL.
Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement.

EORTC QLQ-C30=cancer-specific instrument consisting of 30 questions that evaluated 5 aspects of participant functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting & pain), GHS/QoL & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties).
Functioning & symptom items used a 4-point scale, scores ranging from 1=Not at all to 4=Very much.
GHS/QoL questions used a 7-point scale, scores ranging from 1=Very poor to 7=Excellent.
All EORTC scales & single-item measures were linearly transformed to a score range of 0-100.
High score for functional/GHS scale=high/healthy level of functioning/better HRQoL & high score for symptom scale=high level of symptom severity.
A positive change from baseline=improvement & negative change=worsening in QoL & functioning scales.
A positive change from baseline=deterioration & negative change=improvement in symptom scales.

HCPs who have had experience with the preparation and/or administration of PH FDC SC completed the following questions of the HCPQ: Q1j: How long do you keep implanted IV access in early human epidermal growth factor receptor 2 (HER2)-positive breast cancer participants with pCR following surgery in your institution?
The 5 available responses were: <12 months, ≥12 months, 18 months, <24 months, ≥24 months.
Q1k: When is the decision point for you to decide to remove IV access for early HER2+ breast cancer participants?
The 6 available responses were: Before surgery, After surgery, After PCR results, After completion of full adjuvant therapy, After completion of IV antineoplastic within adjuvant therapy, and Other.
Q1l: Do you consider it necessary to keep implanted IV access knowing that the participant's treatment will be SC until the full 18 cycles?
The 3 available responses were: Yes, No, and Other.
Percentages were rounded off.

HCPs who have had experience with the preparation and/or administration of PH FDC SC completed the following questions of the HCPQ: Q1j: How long do you keep implanted IV access in early human epidermal growth factor receptor 2 (HER2)-positive breast cancer participants with pCR following surgery in your institution?
The 5 available responses were: <12 months, ≥12 months, 18 months, <24 months, ≥24 months.
Q1k: When is the decision point for you to decide to remove IV access for early HER2+ breast cancer participants?
The 6 available responses were: Before surgery, After surgery, After PCR results, After completion of full adjuvant therapy, After completion of IV antineoplastic within adjuvant therapy, and Other.
Q1l: Do you consider it necessary to keep implanted IV access knowing that the participant's treatment will be SC until the full 18 cycles?
The 3 available responses were: Yes, No, and Unsure.
Percentages were rounded off.

EORTC QLQ-C30 is a cancer-specific instrument consisting of 30 questions used to assess the HRQoL in cancer participants.
First 28 questions evaluates 5 aspects of participant functioning (physical, emotional, role, cognitive, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).
These questions used a 4-point scale, with scores ranging from 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much).
The last 2 questions represents the participant's assessment of GHS/QoL, using a 7-point scale with scores ranging from 0-7 (1=very poor to 7=excellent).
EORTC QLQ-C30 scores will be linearly transformed on a scale of 0 - 100, with a high score indicating better GHS/QOL.
Negative change from Baseline values indicates deterioration in QOL or functioning and positive values indicates improvement.

EORTC QLQ-C30=cancer-specific instrument consisting of 30 questions that evaluated 5 aspects of participant functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting & pain), GHS/QoL & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties).
Functioning & symptom items used a 4-point scale, scores ranging from 1=Not at all to 4=Very much.
GHS/QoL questions used a 7-point scale, scores ranging from 1=Very poor to 7=Excellent.
All EORTC scales & single-item measures were linearly transformed to a score range of 0-100.
High score for functional/GHS scale=high/healthy level of functioning/better HRQoL & high score for symptom scale=high level of symptom severity.
A positive change from baseline=improvement & negative change=worsening in QoL & functioning scales.
A positive change from baseline=deterioration & negative change=improvement in symptom scales.

Fundación CENIT para la Investigación en Neurociencias

Centro de Investigaciones Médicas y Desarrollo LC S.R.L

C1125ABD

C1113AAE

2025-11

2025-12

2025-11-19

2025-12-18

2025-12-04

2026-01-12

Overall number analyzed is the number of HCPs who answered Q1a of the HCPQ.
Number analyzed is the number of HCPs who answered Q1a of the HCPQ at the specified time point.

Participants could have changed from P+H IV treatment to PH FDC SC treatment, in exceptional circumstances and at the investigator discretion.
Overall number analyzed is the number of HCPs who answered Q1a of the HCPQ.
Number analyzed is the number of HCPs who answered Q1a of the HCPQ at the specified time point.

Overall number analyzed is the number of HCPs who answered Q1a to Q1e of the HCPQ.
Number analyzed is the number of HCPs who answered Q1a to Q1e of the HCPQ at the specified time point.

Participants could have changed from P+H IV treatment to PH FDC SC treatment, in exceptional circumstances and at the investigator discretion.
Overall number analyzed is the number of HCPs who answered Q1a to Q1e of the HCPQ.
Number analyzed is the number of HCPs who answered Q1a to Q1e of the HCPQ at the specified time point.

Up to approximately 28 months

Up to approximately 7.8 months

EORTC QLQ-C30 is a cancer-specific instrument consisting of 30 questions used to assess the HRQoL in cancer participants.
First 28 questions evaluated 5 aspects of participant functioning (physical, emotional, role, cognitive, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).
These questions used a 4-point scale, with scores ranging from 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much).
The last 2 questions represented the participant's assessment of global health status (GHS) and quality of life (QoL), using a 7-point scale with scores ranging from 0-7 (1=very poor to 7=excellent).
EORTC QLQ-C30 scores were linearly transformed on a scale of 0 - 100, with a high score indicating better GHS/QOL.
Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement.

EORTC QLQ-C30=cancer-specific instrument consisting of 30 questions that evaluated 5 aspects of participant functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting & pain), global health status/quality of life (GHS/QoL) & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties).
Functioning & symptom items used a 4-point scale, scores ranging from 1=Not at all to 4=Very much.
GHS/QoL questions used a 7-point scale, scores ranging from 1=Very poor to 7=Excellent.
All EORTC scales & single-item measures were linearly transformed to a score range of 0-100.
High score for functional/GHS scale=high/healthy level of functioning/better HRQoL & high score for symptom scale=high level of symptom severity.
A positive change from baseline=improvement & negative change=worsening in QoL & functioning scales.
A positive change from baseline=deterioration & negative change=improvement in symptom scales.

EORTC QLQ-C30 is a cancer-specific instrument consisting of 30 questions used to assess the HRQoL in cancer participants.
First 28 questions evaluated 5 aspects of participant functioning (physical, emotional, role, cognitive, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).
These questions used a 4-point scale, with scores ranging from 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much).
The last 2 questions represented the participant's assessment of GHS/QoL, using a 7-point scale with scores ranging from 0-7 (1=very poor to 7=excellent).
EORTC QLQ-C30 scores were linearly transformed on a scale of 0 - 100, with a high score indicating better GHS/QOL.
Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement.

EORTC QLQ-C30=cancer-specific instrument consisting of 30 questions that evaluated 5 aspects of participant functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting & pain), GHS/QoL & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties).
Functioning & symptom items used a 4-point scale, scores ranging from 1=Not at all to 4=Very much.
GHS/QoL questions used a 7-point scale, scores ranging from 1=Very poor to 7=Excellent.
All EORTC scales & single-item measures were linearly transformed to a score range of 0-100.
High score for functional/GHS scale=high/healthy level of functioning/better HRQoL & high score for symptom scale=high level of symptom severity.
A positive change from baseline=improvement & negative change=worsening in QoL & functioning scales.
A positive change from baseline=deterioration & negative change=improvement in symptom scales.

HCPs who have had experience with the preparation and/or administration of PH FDC SC completed the following questions of the HCPQ: Q1j: How long do you keep implanted IV access in early human epidermal growth factor receptor 2 (HER2)-positive breast cancer participants with pCR following surgery in your institution?
The 5 available responses were: <12 months, ≥12 months, 18 months, <24 months, ≥24 months.
Q1k: When is the decision point for you to decide to remove IV access for early HER2+ breast cancer participants?
The 6 available responses were: Before surgery, After surgery, After PCR results, After completion of full adjuvant therapy, After completion of IV antineoplastic within adjuvant therapy, and Other.
Q1l: Do you consider it necessary to keep implanted IV access knowing that the participant's treatment will be SC until the full 18 cycles?
The 3 available responses were: Yes, No, and Other.
Percentages were rounded off.

HCPs who have had experience with the preparation and/or administration of PH FDC SC completed the following questions of the HCPQ: Q1j: How long do you keep implanted IV access in early human epidermal growth factor receptor 2 (HER2)-positive breast cancer participants with pCR following surgery in your institution?
The 5 available responses were: <12 months, ≥12 months, 18 months, <24 months, ≥24 months.
Q1k: When is the decision point for you to decide to remove IV access for early HER2+ breast cancer participants?
The 6 available responses were: Before surgery, After surgery, After PCR results, After completion of full adjuvant therapy, After completion of IV antineoplastic within adjuvant therapy, and Other.
Q1l: Do you consider it necessary to keep implanted IV access knowing that the participant's treatment will be SC until the full 18 cycles?
The 3 available responses were: Yes, No, and Unsure.
Percentages were rounded off.

EORTC QLQ-C30 is a cancer-specific instrument consisting of 30 questions used to assess the HRQoL in cancer participants.
First 28 questions evaluates 5 aspects of participant functioning (physical, emotional, role, cognitive, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).
These questions used a 4-point scale, with scores ranging from 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much).
The last 2 questions represents the participant's assessment of GHS/QoL, using a 7-point scale with scores ranging from 0-7 (1=very poor to 7=excellent).
EORTC QLQ-C30 scores will be linearly transformed on a scale of 0 - 100, with a high score indicating better GHS/QOL.
Negative change from Baseline values indicates deterioration in QOL or functioning and positive values indicates improvement.

EORTC QLQ-C30=cancer-specific instrument consisting of 30 questions that evaluated 5 aspects of participant functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting & pain), GHS/QoL & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties).
Functioning & symptom items used a 4-point scale, scores ranging from 1=Not at all to 4=Very much.
GHS/QoL questions used a 7-point scale, scores ranging from 1=Very poor to 7=Excellent.
All EORTC scales & single-item measures were linearly transformed to a score range of 0-100.
High score for functional/GHS scale=high/healthy level of functioning/better HRQoL & high score for symptom scale=high level of symptom severity.
A positive change from baseline=improvement & negative change=worsening in QoL & functioning scales.
A positive change from baseline=deterioration & negative change=improvement in symptom scales.

Adjuvant safety analysis set (SAScd+) included all participants with pCR who received at least one dose of PH FDC SC during the adjuvant phase.

Adjuvant safety analysis set (SAScd+) included all participants with pCR who received at least one dose of PH FDC SC during the adjuvant phase.
AEs for the cross-over period are pooled per treatment administration setting.

Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home

Adjuvant Cross-Over Period: PH FDC SC in Hospital

Participants who completed the run-in period and were randomized to Arm C received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the hospital setting, followed by 3 cycles in the home setting (Cycle length = 21 days).

Participants who completed the run-in period received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for 3 cycles in the hospital setting during the cross-over period (Cycle length = 21 days).

Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital

Adjuvant Cross-Over Period: PH FDC SC at Home

Participants who completed the run-in period and were randomized to Arm D received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the home setting, followed by 3 cycles in the hospital setting (Cycle length = 21 days).

Participants who completed the run-in period received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for 3 cycles in the home setting during the cross-over period (Cycle length = 21 days).

SAScd+ included all participants with pCR who received at least one dose of PH FDC SC during the adjuvant phase.

SAScd+ included all participants with pCR who received at least one dose of PH FDC SC during the adjuvant phase.
AEs for the cross-over period are pooled per treatment administration setting.

Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home

Adjuvant Cross-Over Period: PH FDC SC in Hospital

Participants who completed the run-in period and were randomized to Arm C received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the hospital setting, followed by 3 cycles in the home setting (Cycle length = 21 days).

Participants who completed the run-in period received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for 3 cycles in the hospital setting during the cross-over period (Cycle length = 21 days).

Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital

Adjuvant Cross-Over Period: PH FDC SC at Home

Participants who completed the run-in period and were randomized to Arm D received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the home setting, followed by 3 cycles in the hospital setting (Cycle length = 21 days).

Participants who completed the run-in period received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for 3 cycles in the home setting during the cross-over period (Cycle length = 21 days).