Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202211579014330 Date of Registration: 08/11/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title 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 (ProHer)
Official scientific title A PHASE IIIB, MULTINATIONAL, MULTICENTER, RANDOMIZED, OPEN-LABEL 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
Brief summary describing the background and objectives of the trial This is a Phase IIIb, multinational, multicenter, randomized, open-label study to evaluate patient preference of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous use (PH FDC SC) administration in the home setting compared with the hospital setting during the cross-over period of adjuvant treatment in participants with early or locally advanced/inflammatory human epidermal growth factor receptor 2-positive (HER2+) breast cancer.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ProHer
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 05/07/2022
Actual trial start date 09/02/2023
Anticipated date of last follow up 25/09/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 330
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Arm A Drug: Pertuzumab IV Pertuzumab is given as a fixed dose of 840 mg intravenous (IV) loading dose and then 420 mg IV for subsequent maintenance doses once every 3 weeks. Drug: Trastuzumab IV Trastuzumab is given as an 8 milligram per kilogram (mg/kg) intravenous (IV) loading dose and then 6 mg/kg IV for subsequent maintenance doses once every 3 weeks. Drug: Investigator's Choice of Chemotherapy Option 1: Docetaxel and carboplatin once every 3 weeks for 6 cycles; Option 2: Doxorubicin plus cyclophosphamide once every 3 weeks for 4 cycles, followed by a taxane (docetaxel once every 3 weeks for 4 cycles or paclitaxel once every week for 12 cycles); Option 3: Dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks for 4 cycles, followed by a taxane (docetaxel once every 3 weeks for 4 cycles or paclitaxel once every week for 12 cycles). Procedure: Surgery After completing their neoadjuvant therapy, participants will undergo surgical resection for early or locally advanced HER2+ breast cancer (if eligible for surgery). Participants may undergo breast-conserving surgery or mastectomy according to routine clinical practice. The surgery cannot be performed ≤2 weeks from the last systemic neoadjuvant therapy and must be performed ≤6 weeks after the last systemic neoadjuvant therapy. Radiation: Radiotherapy After surgery, radiotherapy is to be given as clinically indicated and as per local practice or institutional standards. The selected radiotherapy regimen should be initiated within 4 weeks after surgery. Drug: Pertuzumab IV Pertuzumab is given as a fixed dose of 840 mg intravenous (IV) loading dose and then 420 mg IV for subsequent maintenance doses once every 3 weeks. Other Names: Perjeta RO4368451 Drug: Trastuzumab IV Trastuzumab is given as an 8 milligram per kilogram (mg/kg) intravenous (IV) loading dose and then 6 mg/kg IV for subsequent maintenance doses once every 3 weeks. Other Names: Herceptin RO0452317 Drug: Investigator's Choice of Chemotherapy Option 1: Docetaxel and carboplatin once every 3 weeks for 6 cycles; Option 2: Doxorubicin plus cyclophosphamide once every 3 weeks for 4 cycles, followed by a taxane (docetaxel once every 3 weeks for 4 cycles or paclitaxel once every week for 12 cycles); Option 3: Dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks for 4 cycles, followed by a taxane (docetaxel once every 3 weeks for 4 cycles or paclitaxel once every week for 12 cycles). Procedure: Surgery After completing their neoadjuvant therapy, participants will undergo surgical resection for early or locally advanced HER2+ breast cancer (if eligible for surgery). Participants may undergo breast-conserving surgery or mastectomy according to routine clinical practice. The surgery cannot be performed ≤2 weeks from the last systemic neoadjuvant therapy and must be performed ≤6 weeks after the last systemic neoadjuvant therapy. Radiation: Radiotherapy After surgery, radiotherapy is to be given as clinically indicated and as per local practice or institutional standards. The selected radiotherapy regimen should be initiated within 4 weeks after surgery. During the neoadjuvant phase, the enrolled participants randomized to this arm will receive treatment with pertuzumab and trastuzumab intravenously (IV) plus investigator's choice of chemotherapy. During the neoadjuvant phase, participants will be randomized in a 1:2 ratio to receive treatment in the hospital with either P+H IV plus chemotherapy (Arm A) or PH FDC SC plus chemotherapy (Arm B). Participants in both cohorts are scheduled to undergo surgery after the completion of neoadjuvant therapy. This could be after 6 or 8 cycles depending on the chosen neoadjuvant scheme. Approximately 330 participants will be enrolled for the neoadjuvant phase of study treatment such that approximately 150 evaluable participants enter Arm C and D and complete the crossover period 330 Active-Treatment of Control Group
Control Group Arm B Drug: Fixed Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC) PH FDC SC is administered subcutaneously (SC) as a fixed non-weight-based dose. A loading dose of 1200 milligram (mg) pertuzumab, 600 mg trastuzumab, and 30,000 units of recombinant human PH20 hyaluronidase (rHuPH20) is given in the first cycle (1 cycle is 21 days). In subsequent cycles, maintenance doses of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units rHuPH20 are administered once every 3 weeks (Q3W). Other Names: PHESGO Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Pertuzumab, Trastuzumab, and rHuPH20 RO7198574 RG6264 Drug: Investigator's Choice of Chemotherapy Option 1: Docetaxel and carboplatin once every 3 weeks for 6 cycles; Option 2: Doxorubicin plus cyclophosphamide once every 3 weeks for 4 cycles, followed by a taxane (docetaxel once every 3 weeks for 4 cycles or paclitaxel once every week for 12 cycles); Option 3: Dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks for 4 cycles, followed by a taxane (docetaxel once every 3 weeks for 4 cycles or paclitaxel once every week for 12 cycles). Procedure: Surgery After completing their neoadjuvant therapy, participants will undergo surgical resection for early or locally advanced HER2+ breast cancer (if eligible for surgery). Participants may undergo breast-conserving surgery or mastectomy according to routine clinical practice. The surgery cannot be performed ≤2 weeks from the last systemic neoadjuvant therapy and must be performed ≤6 weeks after the last systemic neoadjuvant therapy. Radiation: Radiotherapy After surgery, radiotherapy is to be given as clinically indicated and as per local practice or institutional standards. The selected radiotherapy regimen should be initiated within 4 weeks after surgery. Drug: Fixed Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC) PH FDC SC is administered subcutaneously (SC) as a fixed non-weight-based dose. A loading dose of 1200 milligram (mg) pertuzumab, 600 mg trastuzumab, and 30,000 units of recombinant human PH20 hyaluronidase (rHuPH20) is given in the first cycle (1 cycle is 21 days). In subsequent cycles, maintenance doses of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units rHuPH20 are administered once every 3 weeks (Q3W). Other Names: PHESGO Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Pertuzumab, Trastuzumab, and rHuPH20 RO7198574 RG6264 Drug: Investigator's Choice of Chemotherapy Option 1: Docetaxel and carboplatin once every 3 weeks for 6 cycles; Option 2: Doxorubicin plus cyclophosphamide once every 3 weeks for 4 cycles, followed by a taxane (docetaxel once every 3 weeks for 4 cycles or paclitaxel once every week for 12 cycles); Option 3: Dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks for 4 cycles, followed by a taxane (docetaxel once every 3 weeks for 4 cycles or paclitaxel once every week for 12 cycles). Procedure: Surgery After completing their neoadjuvant therapy, participants will undergo surgical resection for early or locally advanced HER2+ breast cancer (if eligible for surgery). Participants may undergo breast-conserving surgery or mastectomy according to routine clinical practice. The surgery cannot be performed ≤2 weeks from the last systemic neoadjuvant therapy and must be performed ≤6 weeks after the last systemic neoadjuvant therapy. Radiation: Radiotherapy After surgery, radiotherapy is to be given as clinically indicated and as per local practice or institutional standards. The selected radiotherapy regimen should be initiated within 4 weeks after surgery. During the neoadjuvant phase, the enrolled participants randomized to this arm will receive treatment with the fixed dose combination of pertuzumab and trastuzumab for subcutaneous use (PH FDC SC) plus investigator's choice of chemotherapy. During the neoadjuvant phase, participants will be randomized in a 1:2 ratio to receive treatment in the hospital with either P+H IV plus chemotherapy (Arm A) or PH FDC SC plus chemotherapy (Arm B). Participants in both cohorts are scheduled to undergo surgery after the completion of neoadjuvant therapy. This could be after 6 or 8 cycles depending on the chosen neoadjuvant scheme. Approximately 330 participants will be enrolled for the neoadjuvant phase of study treatment such that approximately 150 evaluable participants enter Arm C and D and complete the crossover period 330 Active-Treatment of Control Group
Experimental Group Arm C Drug: Fixed Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC) PH FDC SC is administered subcutaneously (SC) as a fixed non-weight-based dose. A loading dose of 1200 milligram (mg) pertuzumab, 600 mg trastuzumab, and 30,000 units of recombinant human PH20 hyaluronidase (rHuPH20) is given in the first cycle (1 cycle is 21 days). In subsequent cycles, maintenance doses of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units rHuPH20 are administered once every 3 weeks (Q3W). Other Names: PHESGO Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Pertuzumab, Trastuzumab, and rHuPH20 RO7198574 RG6264 Drug: Fixed Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC) PH FDC SC is administered subcutaneously (SC) as a fixed non-weight-based dose. A loading dose of 1200 milligram (mg) pertuzumab, 600 mg trastuzumab, and 30,000 units of recombinant human PH20 hyaluronidase (rHuPH20) is given in the first cycle (1 cycle is 21 days). In subsequent cycles, maintenance doses of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units rHuPH20 are administered once every 3 weeks (Q3W). Other Names: PHESGO Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Pertuzumab, Trastuzumab, and rHuPH20 RO7198574 RG6264 Adjuvant PH FDC SC in Hospital, Then at Home During the adjuvant phase, participants who have achieved pCR after surgery will be treated with 2 cycles of PH FDC SC in the hospital (run-in period). After completion of the last cycle of radiotherapy and the last cycle of PH FDC SC (run-in period), participants will then be randomized with a ratio of 1:1 into one of two treatment arms (Arm C or D) in a cross-over treatment period to receive the next 6 cycles of PH FDC SC treatment. Participants in Arm C will receive 3 cycles of PH FDC SC in the hospital and then 3 cycles of PH FDC SC in the home setting. After the cross-over treatment period, participants will receive the remaining PH FDC SC treatment cycles required to complete the planned 18 cycles of HER2-directed therapy, unless of disease recurrence, unacceptable toxicity, or withdrawal. Study treatment during this treatment continuation period will be administered either in the hospital or in the home setting as selected by the participant at the end of the crossover period. Approximately 330 participants will be enrolled for the neoadjuvant phase of study treatment such that approximately 150 evaluable participants enter Arm C and D and complete the crossover period 150
Experimental Group Arm D Drug: Fixed Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC) PH FDC SC is administered subcutaneously (SC) as a fixed non-weight-based dose. A loading dose of 1200 milligram (mg) pertuzumab, 600 mg trastuzumab, and 30,000 units of recombinant human PH20 hyaluronidase (rHuPH20) is given in the first cycle (1 cycle is 21 days). In subsequent cycles, maintenance doses of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units rHuPH20 are administered once every 3 weeks (Q3W). Other Names: PHESGO Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Pertuzumab, Trastuzumab, and rHuPH20 RO7198574 RG6264 Drug: Fixed Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC) PH FDC SC is administered subcutaneously (SC) as a fixed non-weight-based dose. A loading dose of 1200 milligram (mg) pertuzumab, 600 mg trastuzumab, and 30,000 units of recombinant human PH20 hyaluronidase (rHuPH20) is given in the first cycle (1 cycle is 21 days). In subsequent cycles, maintenance doses of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units rHuPH20 are administered once every 3 weeks (Q3W). Other Names: PHESGO Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Pertuzumab, Trastuzumab, and rHuPH20 RO7198574 RG6264 Adjuvant PH FDC SC at Home, Then in Hospital During the adjuvant phase, participants who have achieved pCR after surgery will be treated with 2 cycles of PH FDC SC in the hospital (run-in period). After completion of the last cycle of radiotherapy and the last cycle of PH FDC SC (run-in period), participants will then be randomized with a ratio of 1:1 into one of two treatment arms (Arm C or D) in a cross-over treatment period to receive the next 6 cycles of PH FDC SC treatment. Participants in Arm D will receive 3 cycles of PH FDC SC in the home setting and then 3 cycles of PH FDC SC in the hospital. After the cross-over treatment period, participants will receive the remaining PH FDC SC treatment cycles required to complete the planned 18 cycles of HER2-directed therapy, unless of disease recurrence, unacceptable toxicity, or withdrawal. Study treatment during this treatment continuation period will be administered either in the hospital or in the home setting as selected by the participant at the end of the crossover period. Approximately 330 participants will be enrolled for the neoadjuvant phase of study treatment such that approximately 150 evaluable participants enter Arm C and D and complete the crossover period 150
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Eastern Cooperative Oncology Group (ECOG) performance status 0-1 -Intact skin at planned site of subcutaneous (SC) injections -Left ventricular ejection fraction (LVEF) greater than or equal to (≥)55% by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) -Negative human immunodeficiency virus (HIV) test at screening -Negative hepatitis B surface antigen (HBsAg) test at screening -Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following: Negative total hepatitis B core antibody (HBcAb); Positive total HBcAb test followed by a negative (per local laboratory definition) hepatitis B virus (HBV) DNA test -Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening -For female participants of childbearing potential: agreement to remain abstinent or use contraception and agree to refrain from donating eggs during the treatment period and for 7 months after the final dose of the study treatment -For male participants: agreement to remain abstinent or use a condom, and agree to refrain from donating sperm during the treatment period and for 7 months after the final dose of study treatment -Stage IV (metastatic) breast cancer -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 -Participants who are pregnant or breastfeeding or intending to become pregnant during the study or within 7 months after the final dose of study treatments -Treatment with investigational therapy within 28 days prior to initiation of study treatment -Active, unresolved infections at screening requiring treatment -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)-Serious cardiac illness or medical conditions -History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias-Inadequate bone marrow function-Impaired liver function-Renal function with creatinine clearance <50 mL/min using the Cockroft-Gault formula and serum creatinine >1.5x upper limit of normal (ULN) -Major surgical procedure unrelated to breast cancer within 28 days prior to study entry or anticipation of the need for major surgery during the course of study treatment -Current severe, uncontrolled systemic disease that may interfere with planned treatment -Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study -Known active liver disease, for example, active viral hepatitis infection, autoimmune hepatic disorders, or sclerosing cholangitis -Known hypersensitivity to any of the study drugs, excipients, and/or murine proteins or a history of severe allergic or immunological reactions, e.g., difficult to control asthma-Current chronic daily treatment with corticosteroids 80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/09/2022 Aga Khan University Nairobi Institutional Scientific and Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
3rd Parklands Avenue, off Limuru Road, P 0. Box 30270, GPO 00100, Nairobi, Kenya Nairobi 00100 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/10/2022 KEMRI Scientific and Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
OFF MBAGATHI ROAD, NAIROBI, KENYA Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Percentage of Participants Who Preferred the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting, Question 1 of the Patient Preference Questionnaire [ Time Frame: Day 1 of Cycle 8 of adjuvant treatment (1 cycle is 3 weeks) ] Day 1 of Cycle 8 of adjuvant treatment
Secondary Outcome -Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1 of the Healthcare Professional Questionnaire (HCPQ) - Neoadjuvant Phase Drug Preparation Area [ Time Frame: Day 1 of each cycle from Cycle 1 to last cycle (Cycle 6 or 8) of neoadjuvant treatment (1 cycle is 3 weeks) ] -Percentage of Healthcare Professionals by Their Responses on Perception of Impact of PH FDC SC on Clinical Management and Clinical Efficiency, Question 2 of the HCPQ - Neoadjuvant Phase Drug Preparation Area [ Time Frame: Day 1 of last cycle (Cycle 6 or 8) of neoadjuvant treatment (1 cycle is 3 weeks) ] -Percentage of Healthcare Professionals by Their Responses on Perception of Time/Resource Use of Each Study Regimen, Questions 3 and 4 of the HCPQ - Neoadjuvant Phase Drug Preparation Area [ Time Frame: Day 1 of last cycle (Cycle 6 or 8) of neoadjuvant treatment (1 cycle is 3 weeks) ] -Duration of Treatment Administration Activities, According to Healthcare Professionals' Responses to Question 1 of the HCPQ - Neoadjuvant Phase Administering Treatment [ Time Frame: Day 1 of each cycle from Cycle 1 to last cycle (Cycle 6 or 8) of neoadjuvant treatment (1 cycle is 3 weeks) ] -Percentage of Healthcare Professionals by Their Responses on Perception of Impact of PH FDC SC on Clinical Management and Clinical Efficiency, Question 2 of the HCPQ - Neoadjuvant Phase Administering Treatment [ Time Frame: Day 1 of last cycle (Cycle 6 or 8) of neoadjuvant treatment (1 cycle is 3 weeks) ] See the timeline listed on the outcome section
Secondary Outcome -Percentage of Healthcare Professionals by Their Responses on Perception of Time/Resource Use and Convenience of Each Study Regimen, Questions 3 to 10 of the HCPQ - Neoadjuvant Phase Administering Treatment [ Time Frame: Day 1 of last cycle (Cycle 6 or 8) of neoadjuvant treatment (1 cycle is 3 weeks) ] -Percentage of Healthcare Professionals by Their Responses to Question 11 of the HCPQ - Neoadjuvant Phase Administering Treatment [ Time Frame: Day 1 of last cycle (Cycle 6 or 8) of neoadjuvant treatment (1 cycle is 3 weeks) ] -Percentage of Participants Achieving Pathologic Complete Response (pCR) [ Time Frame: Post-surgery (up to 27 weeks) ] pCR is defined as eradication of invasive disease in the breast and axilla (i.e., ypT0/Tis ypN0), according to local pathologist assessment following the American Joint Committee on Cancer (AJCC) criteria. -Health-Related Quality of Life Assessed by the European Organization for Research and Treatment of Cancer Core Quality of Life (EORTC QLQ)-C30 Questionnaire Scores in the Neoadjuvant Phase [ Time Frame: Day 1 of Cycle 1 and Day 1 of last cycle of neoadjuvant treatment (Cycle 6 or 8; 1 cycle is 3 weeks) ] -Health-Related Quality of Life Assessed by the EORTC QLQ-C30 Questionnaire Scores in Participants Treated with PH FDC SC During the Adjuvant Phase [ Time Frame: Day 1 of Cycles 1, 3, 5, 8, and last cycle of adjuvant treatment (1 cycle is 3 weeks) ] See the timeline listed on the outcome section
Secondary Outcome -Health-Related Quality of Life Assessed by the EORTC QLQ-C30 Questionnaire Scores in Participants Treated with Trastuzumab Emtansine During the Adjuvant Phase [ Time Frame: Day 1 of Cycles 1, 7, and 14 of adjuvant treatment (1 cycle is 3 weeks) ] -Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1 of the HCPQ - Adjuvant Phase Drug Preparation Area [ Time Frame: Day 1 of Cycles 5 and 8 of adjuvant treatment (1 cycle is 3 weeks) ] -Percentage of Healthcare Professionals by Their Responses on Perception of the Treatment Setting's Impact on Clinical Management and Clinical Efficiency, Question 2 of the HCPQ - Adjuvant Phase Drug Preparation Area [ Time Frame: Day 1 of Cycle 8 of adjuvant treatment (1 cycle is 3 weeks) ] -Percentage of Healthcare Professionals by Their Responses on Perception of Time/Resource Use in the Home and Hospital Settings, Questions 3 and 4 of the HCPQ - Adjuvant Phase Drug Preparation Area [ Time Frame: Day 1 of Cycle 8 of adjuvant treatment (1 cycle is 3 weeks) ] -Duration of Treatment Administration Activities, According to Healthcare Professionals' Responses to Question 1 of the HCPQ - Adjuvant Phase Administering Treatment [ Time Frame: Day 1 of Cycles 5 and 8 of adjuvant treatment (1 cycle is 3 weeks) ] -Percentage of Healthcare Professionals by Their Responses on Perception of the Treatment Setting's Impact on Clinical Management and Clinical Efficiency, Question 2 of the HCPQ - Adjuvant Phase Administering Treatment [ Time Frame: Day 1 of Cycle 8 of adjuvant treatment (1 cycle is 3 weeks) ] -Percentage of Healthcare Professionals by Their Responses on Perception of Time/Resource Use in the Home and Hospital Settings, Questions 3 to 6 of the HCPQ - Adjuvant Phase Administering Treatment [ Time Frame: Day 1 of Cycle 8 of adjuvant treatment (1 cycle is 3 weeks) ] See the timeline listed on the outcome section
Secondary Outcome -Percentage of Healthcare Professionals by Their Responses to Question 7 of the HCPQ - Adjuvant Phase Administering Treatment [ Time Frame: Day 1 of Cycle 8 of adjuvant treatment (1 cycle is 3 weeks) ] -Number of Participants with at Least One Adverse Event During the Neoadjuvant Treatment Phase, with Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) [ Time Frame: From Baseline until surgery (up to 27 weeks) ] -Incidence of Premature Withdrawal from Neoadjuvant Treatment with PH FDC SC or Pertuzumab IV and Trastuzumab IV [ Time Frame: From Cycle 1 to last cycle (Cycle 6 or 8) of neoadjuvant treatment (1 cycle is 3 weeks) ] -Number of Participants with Clinical Laboratory Test Abnormalities During the Neoadjuvant Treatment Phase [ Time Frame: From Baseline until surgery (up to 27 weeks) ] -Number of Participants with Vital Sign Abnormalities During the Neoadjuvant Treatment Phase [ Time Frame: From Baseline until surgery (up to 27 weeks) ] -Number of Participants with at Least One Adverse Event During the Adjuvant Treatment Phase, with Severity Determined According to the NCI CTCAE v5.0 [ Time Frame: From first dose post-surgery up to 9 months after the last dose of adjuvant treatment (up to 2 years) ] -Incidence of Premature Withdrawal from Adjuvant Treatment with PH FDC SC [ Time Frame: From Cycle 1 to last cycle (Cycle 12 or 14) of adjuvant treatment (1 cycle is 3 weeks) ] See the timeline listed on the outcome section
Secondary Outcome -Incidence of Premature Withdrawal from Adjuvant Treatment with Trastuzumab Emtansine [ Time Frame: From Cycle 1 to Cycle 14 (last cycle; 1 cycle is 3 weeks) ] -Number of Participants with Clinical Laboratory Test Abnormalities During the Adjuvant Treatment Phase [ Time Frame: From first dose post-surgery until the last dose of adjuvant treatment (up to 1.5 years) ] -Number of Participants with Vital Sign Abnormalities During the Adjuvant Treatment Phase [ Time Frame: From first dose post-surgery until the last dose of adjuvant treatment (up to 1.5 years) ] See the timeline listed on the outcome section
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aga Khan University 3rd Parklands Avenue, Off Limuru Road Nairobi 00100 Kenya
International Cancer Institute Nandi Road 8/10, Eldoret, Kenya, 8088-30100 Eldoret 30100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Hoffmann La Roche The Atrium, 6th Floor Chaka Road, off Lenana Road P.O. Box 44212-00100 Nairobi, Kenya Nairobi 00100 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hoffmann La Roche The Atrium, 6th Floor Chaka Road, off Lenana Road P.O. Box 44212-00100 Nairobi, Kenya Nairobi 00100 Kenya Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Saleh Mansoor mansoor.saleh@aku.edu +254709931500 Aga Khan University, Nairobi, 3rd Parklands Avenue, Nairobi-Kenya
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Professor of Hematology and Oncology
Role Name Email Phone Street address
Principal Investigator Fredrick Asirwa director@intercancer.com +254700522149 International Cancer Institute, Nandi Road 8/10, Eldoret, Kenya, 8088-30100
City Postal code Country Position/Affiliation
Eldoret 30100 Kenya Professor of Hematology and Oncology
Role Name Email Phone Street address
Public Enquiries Gladys Mills gladys.mills@roche.com +233593813966 Accra
City Postal code Country Position/Affiliation
Accra Ghana CSM and Start Up Manager Area Africa CONAA
Role Name Email Phone Street address
Scientific Enquiries Donna Dela Cruz donna.delacruz@ppd.com +61410407677 Level 5, 412 St Kilda Road Melbourne VIC 3004 Australia
City Postal code Country Position/Affiliation
Melbourne Australia Senior Clinical Team Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Plan description: -Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm). Clinical Study Report Roche commits to submit a manuscript to a peer-reviewed journal reporting primary clinical trials results no later than 18 months after the first product approval or decision to discontinue development of the product. Available studies are listed and available on the Vivli platform. Data requestors should use the Vivli data request form to request companies data Package(s). If approved requestors will need to sign a Data Use Agreement and the anonymized data will be shared in the Vivli secure research environment.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://vivli.org/ourmember/roche/ No
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