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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

F. Hoffmann-La Roche AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

28 Jun 2022 → 7 Nov 2025

Decision date (initial)

2024-06-13

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

F. Hoffmann-La Roche AG

External identifiers

EU CT number

2023-506380-33-00

EudraCT number

2021-002346-33

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others, Efficacy

To evaluate patient preference of pertuzumab and trastuzumab (PH) fixed-dose combination (FDC) for subcutaneous (SC) administration in the home setting during the cross-over period of the adjuvant phase of the study

Secondary objectives 9

1. To evaluate the perception of healthcare professionals (HCPs) of time/resource use and convenience of PH FDC SC compared to P+H IV duringthe neoadjuvant phase of the study
2. Collect pathologic complete response (pCR) data post-surgery
3. To evaluate Health-related Quality of Life (HRQoL) during the neoadjuvant phase of the study and with PH FDC SC administered during the adjuvant phase of the study
4. To evaluate the perception of HCPs of time/resource use of PH FDC SC during adjuvant cross-over period
5. To evaluate HRQoL for participants treated with trastuzumab emtansine IV during the adjuvant phase
6. To evaluate the safety and tolerability of PH FDC SC and P+H IV during neoadjuvant phase of the study
7. To evaluate the safety and tolerability of PH FDC SC administered in the home setting and hospital setting during the cross-over period and the entire adjuvant treatment period
8. To evaluate the safety and tolerability of trastuzumab emtansine IV during the adjuvant phase of the study
9. To evaluate patient’s choice of setting for the treatment continuation period

Conditions and MedDRA coding

Early or Locally Advanced/ Inflammatory HER2-Positive Breast Cancer

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
2. Female and male participants with stage II-IIIC early or locally advanced/inflammatory HER2+ breast cancer
3. Primary tumor > 2 cm in diameter, or node-positive disease
4. HER2+ breast cancer confirmed by a local laboratory prior to study enrollment
5. Hormone receptor status of the primary tumor determined by local assessment following American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines and updates
6. Adequate wound healing after breast cancer surgery per investigator’s assessment to allow initiation of study treatment within ≤ 9 weeks of last systemic neoadjuvant therapy

Exclusion criteria 6

1. Stage IV breast cancer
2. History of concurrent or previously treated non-breast malignancies except for appropriately treated 1) non-melanoma skin cancer and/or 2) in situ carcinomas, including cervix, colon, and skin. A participant with previous invasive non-breast cancer is eligible provided he/she has been disease free for more than 5 years
3. Participants who may have had a recent episode of thromboembolism and are still trying to optimize the anticoagulation dose and/or have not normalized their International Normalized Ratio (INR)
4. Inadequate bone marrow function defined by any of: - Participants who have an absolute neutrophil count (ANC) < 1.5 x 109/L - Platelet count < 100 x 109/L - Hemoglobin < 9 g/dL
5. Participants who have received any previous systemic therapy (including chemotherapy, immunotherapy, HER2-targeted agents, endocrine therapy [selective estrogen receptor modulators, aromatase inhibitors], and antitumor vaccines for treatment or prevention of breast cancer, or previous chest irradiation radiation therapy for the treatment of cancer
6. Participants who have a past history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) if they have received any systemic therapy for its treatment or radiation therapy to the ipsi- or contralateral breast cancer. Participants are allowed to enter the studyif treated with surgery alone

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1. Proportion of participants who preferred the administration of PH FDC SC in the home setting compared with the hospital setting in Question 1 of Patient Preference Questionnaire (PPQ)

Secondary endpoints 13

1. 1. Responses of HCPs to the Healthcare Professional Questionnaire (HCPQ) by individual questions in the neoadjuvant phase
2. 2. Proportion of participants achieving pCR, defined as eradication of invasive disease in the breast and axilla (i.e., ypT0/Tis ypN0), according to local pathologist assessment following the AJCC criteria
3. 3. HRQoL assessed by European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ)-C30 scores in the neoadjuvant phase
4. 4. HRQoL assessed by EORTC QLQ-C30 scores in the participants treated with PH FDC SC during the adjuvant phase
5. 5. Responses of HCPs to the HCPQ by individual questions in the adjuvant cross-over period
6. 6. HRQoL assessed by EORTC QLQ-C30 scores in the participants treated with trastuzumab emtansine IV during the adjuvant phase
7. 7. Proportion of participants who selected the administration of PH FDC SC in the home setting compared with the hospital setting in the treatment continuation period
8. 8. Incidence, nature and severity of all Adverse events (AEs), Grade ≥ 3 AEs, Serious adverse event (SAEs), and cardiac AEs (including LVEF events) with severity determined according to National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) v5.0
9. 9. Incidence of premature withdrawal from the neoadjuvant treatment with PH FDC SC and P+H IV
10. 10. Incidence of premature withdrawal from the adjuvant treatment with PH FDC SC
11. 11. Incidence of premature withdrawal from the treatment with trastuzumab emtansine IV
12. 12. Targeted vital signs and Physical findings
13. 13. Targeted clinical laboratory test results

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

Sponsor organisation

F. Hoffmann-La Roche AG

Address

Grenzacherstrasse 124

City

Basel

Postcode

4058

Country

Switzerland

Scientific contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Public contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Third parties 6

Locations

3 EU/EEA countries · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 26 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications