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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)

Primary Purpose

Early Breast Cancer, Locally Advanced Breast Cancer, Inflammatory Breast Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fixed Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC)
Pertuzumab IV
Trastuzumab IV
Trastuzumab Emtansine
Investigator's Choice of Chemotherapy
Surgery
Radiotherapy
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Breast Cancer focused on measuring patient preference, home administration, fixed-dose combination of pertuzumab and trastuzumab, subcutaneous administration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Disease-specific Inclusion Criteria:

  • Female and male participants with stage II-IIIC early or locally advanced/inflammatory human epidermal growth factor receptor 2-positive (HER2+) breast cancer
  • Primary tumor >2 centimetres (cm) in diameter, or node-positive disease
  • HER2+ breast cancer confirmed by a local laboratory prior to study enrollment. HER2+ status will be determined based on pretreatment breast biopsy material and defined as 3+ by Immunohistochemistry (IHC) and/or positive by HER2 amplification by in situ hybridization (ISH) following American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines 2018 and updates (Wolff et al. Arch Pathol Lab Med 2018)
  • 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 (Allison et al. J Clin Oncol 2020)
  • Agreement to undergo mastectomy or breast conserving surgery after neoadjuvant therapy, including the axillary nodes
  • Availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue block for local confirmation of HER2 and hormone receptor status following current ASCO/CAP guidelines

Inclusion Criteria for Treatment with Adjuvant PH FDC SC:

  • Completed the neoadjuvant phase of this study and underwent surgery, and achieved pathologic complete response (pCR), defined as eradication of invasive disease in the breast and axilla according to the current American Joint Committee on Cancer (AJCC) staging system classification, and using the resected specimen by the local pathologist on the basis of guidelines to be provided in a pathology manual
  • Adequate wound healing after breast cancer surgery per investigator's assessment to allow initiation of study treatment within less than or equal to (≤)9 weeks of last systemic neoadjuvant therapy

Exclusion Criteria:

  • 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
  • Assessment by the investigator as being unable or unwilling to comply with the requirements of the protocol

Cancer-specific Exclusion Criteria for Neoadjuvant Phase:

  • Participants who have received any previous systemic therapy for treatment or prevention of breast cancer, or radiation therapy for the treatment of cancer
  • 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 with high-risk for breast cancer who have received chemopreventive drugs in the past
  • Participants with multicentric breast cancer, unless all tumors are HER2+
  • Participants with bilateral breast cancer
  • Participants who have undergone an excisional biopsy of primary tumor and/or axillary lymph nodes
  • Axillary lymph node dissection (ALND) prior to initiation of neoadjuvant therapy
  • Sentinel lymph node biopsy (SLNB) prior to neoadjuvant therapy

Exclusion Criterion for Treatment with Adjuvant Trastuzumab Emtansine (Arm E):

  • Current Grade ≥3 peripheral neuropathy (according to the NCI CTCAE v5.0)

Sites / Locations

  • Fundación CENIT para la Investigación en NeurocienciasRecruiting
  • Centro Oncologico Korben; OncologyRecruiting
  • University Clinical Center of the Republic of SrpskaRecruiting
  • Cantonal Hospital Zenica; Department for OncologyRecruiting
  • Crio - Centro Regional Integrado de Oncologia
  • Hospital Araujo Jorge; Departamento de Ginecologia E Mama
  • Hospital Moinhos de Vento
  • Hospital Nossa Senhora da Conceicao
  • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria LtdaRecruiting
  • Multiprofile Hospital for Active Treatment Uni Hospital; Department of medicinal oncologyRecruiting
  • UMHAT Dr Georgi Stranski; Medical Oncology DepartmentRecruiting
  • University Multiprofile Hospital for Active Treatment Sveta Marina Pleven OODRecruiting
  • DDODIU-Plovdiv, EOOD; Third Internal DepartmentRecruiting
  • MHAT NadezhdaRecruiting
  • Royal Victoria Regional Health CentreRecruiting
  • Lakeridge Health OshawaRecruiting
  • North York General HospitalRecruiting
  • Jewish General Hospital
  • Hopital du Saint Sacrement
  • Centro de Estudios Clínicos SAGARecruiting
  • Clinica VespucioRecruiting
  • Hospital Metropolitano (Sede Lindora-Santa Ana); Centro de Cancer
  • Clinica CIMCA
  • ICIMED Instituto de Investigación en Ciencias Médicas
  • Clinical Hospital Centre ZagrebRecruiting
  • Max Institute of Cancer Care
  • Saifee HospitalRecruiting
  • TATA Medical Centre; Medical OncologyRecruiting
  • International Cancer Institute (ICI)Recruiting
  • Aga Khan University HospitalRecruiting
  • Korea University Anam Hospital
  • Samsung Medical Center
  • Health Pharma Professional ResearchRecruiting
  • Iem-FucamRecruiting
  • Oncologico Potosino
  • Instituto Regional de Enfermedades Neoplásicas del Sur; Centro de Inv. de Medicina OncológicaRecruiting
  • Instituto Nacional de Enfermedades Neoplasicas
  • Oncocenter Peru S.A.C.; OncosaludRecruiting
  • Instituto Regional de Enfermedades Neoplasicas - IREN Norte
  • National University Hospital; National University Cancer Institute, Singapore (NCIS)
  • National Cancer Centre; Medical Oncology
  • Tan Tock Seng Hospital; OncologyRecruiting
  • Medical Oncology Centre of Rosebank; Oncology
  • Wilgers Oncology Centre
  • University of Pretoria Oncology Department; Medical Oncology
  • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
  • Hospital Universitario Virgen de Arrixaca; Servicio de OncologiaRecruiting
  • Hospital Clinico Universitario de Salamanca; Servicio de OncologiaRecruiting
  • Gulhane Training and Research HospitalRecruiting
  • Ankara City Hospital; OncologyRecruiting
  • Trakya University Medical Faculty Research And Practice Hospital Medical Oncology DepartmentRecruiting
  • Ba?c?lar Medipol Mega Üniversite Hastanesi; Oncology
  • Hacettepe Uni Medical Faculty Hospital; Oncology DeptRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Other

Other

Experimental

Experimental

Other

Arm Label

Arm A: Pertuzumab IV and Trastuzumab IV Plus Investigator's Choice of Chemotherapy

Arm B: PH FDC SC Plus Investigator's Choice of Chemotherapy

Arm C: Adjuvant PH FDC SC in Hospital, Then at Home

Arm D: Adjuvant PH FDC SC at Home, Then in Hospital

Arm E: Adjuvant Trastuzumab Emtansine

Arm Description

During the neoadjuvant phase, the enrolled participants randomized to this arm will receive treatment with pertuzumab and trastuzumab intravenously (PH IV) plus investigator's choice of chemotherapy (Option 1, 2, or 3). With chemotherapy Option 1, PH IV will be administered at each cycle from Cycles 1 to 6 (1 cycle is 3 weeks); with chemotherapy Options 2 and 3, PH IV will be administered once per cycle from Cycles 5 to 8 (1 cycle is 3 weeks).

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 (Option 1, 2, or 3). With chemotherapy Option 1, PH FDC SC will be administered at each cycle from Cycles 1 to 6 (1 cycle is 3 weeks); with chemotherapy Options 2 and 3, PH FDC SC will be administered once per cycle from Cycles 5 to 8 (1 cycle is 3 weeks).

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.

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.

Participants with pathological evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy and surgery will enter Arm E to receive trastuzumab emtansine for 14 cycles. Trastuzumab emtansine will be administered IV in the hospital as per prescribing information.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1 of the Healthcare Professional Questionnaire (HCPQ) - Neoadjuvant Phase Drug Preparation Area
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
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
Duration of Treatment Administration Activities, According to Healthcare Professionals' Responses to Question 1 of the HCPQ - Neoadjuvant Phase Administering Treatment
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
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
Percentage of Healthcare Professionals by Their Responses to Question 11 of the HCPQ - Neoadjuvant Phase Administering Treatment
Percentage of Participants Achieving Pathologic Complete Response (pCR)
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
Health-Related Quality of Life Assessed by the EORTC QLQ-C30 Questionnaire Scores in Participants Treated with PH FDC SC During the Adjuvant Phase
Health-Related Quality of Life Assessed by the EORTC QLQ-C30 Questionnaire Scores in Participants Treated with Trastuzumab Emtansine During the Adjuvant Phase
Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1 of the HCPQ - Adjuvant Phase Drug Preparation Area
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
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
Duration of Treatment Administration Activities, According to Healthcare Professionals' Responses to Question 1 of the HCPQ - Adjuvant Phase Administering Treatment
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
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
Percentage of Healthcare Professionals by Their Responses to Question 7 of the HCPQ - Adjuvant Phase Administering Treatment
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)
Incidence of Premature Withdrawal from Neoadjuvant Treatment with PH FDC SC or Pertuzumab IV and Trastuzumab IV
Number of Participants with Clinical Laboratory Test Abnormalities During the Neoadjuvant Treatment Phase
Number of Participants with Vital Sign Abnormalities During the Neoadjuvant Treatment Phase
Number of Participants with at Least One Adverse Event During the Adjuvant Treatment Phase, with Severity Determined According to the NCI CTCAE v5.0
Incidence of Premature Withdrawal from Adjuvant Treatment with PH FDC SC
Incidence of Premature Withdrawal from Adjuvant Treatment with Trastuzumab Emtansine
Number of Participants with Clinical Laboratory Test Abnormalities During the Adjuvant Treatment Phase
Number of Participants with Vital Sign Abnormalities During the Adjuvant Treatment Phase

Full Information

First Posted
June 8, 2022
Last Updated
October 4, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT05415215
Brief 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
Acronym
ProHer
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2022 (Actual)
Primary Completion Date
August 5, 2024 (Anticipated)
Study Completion Date
September 25, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Breast Cancer, Locally Advanced Breast Cancer, Inflammatory Breast Cancer
Keywords
patient preference, home administration, fixed-dose combination of pertuzumab and trastuzumab, subcutaneous administration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Pertuzumab IV and Trastuzumab IV Plus Investigator's Choice of Chemotherapy
Arm Type
Other
Arm Description
During the neoadjuvant phase, the enrolled participants randomized to this arm will receive treatment with pertuzumab and trastuzumab intravenously (PH IV) plus investigator's choice of chemotherapy (Option 1, 2, or 3). With chemotherapy Option 1, PH IV will be administered at each cycle from Cycles 1 to 6 (1 cycle is 3 weeks); with chemotherapy Options 2 and 3, PH IV will be administered once per cycle from Cycles 5 to 8 (1 cycle is 3 weeks).
Arm Title
Arm B: PH FDC SC Plus Investigator's Choice of Chemotherapy
Arm Type
Other
Arm Description
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 (Option 1, 2, or 3). With chemotherapy Option 1, PH FDC SC will be administered at each cycle from Cycles 1 to 6 (1 cycle is 3 weeks); with chemotherapy Options 2 and 3, PH FDC SC will be administered once per cycle from Cycles 5 to 8 (1 cycle is 3 weeks).
Arm Title
Arm C: Adjuvant PH FDC SC in Hospital, Then at Home
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm D: Adjuvant PH FDC SC at Home, Then in Hospital
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm E: Adjuvant Trastuzumab Emtansine
Arm Type
Other
Arm Description
Participants with pathological evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy and surgery will enter Arm E to receive trastuzumab emtansine for 14 cycles. Trastuzumab emtansine will be administered IV in the hospital as per prescribing information.
Intervention Type
Drug
Intervention Name(s)
Fixed Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC)
Other Intervention Name(s)
PHESGO, Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf, Pertuzumab, Trastuzumab, and rHuPH20, RO7198574, RG6264
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Pertuzumab IV
Other Intervention Name(s)
Perjeta, RO4368451
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Trastuzumab IV
Other Intervention Name(s)
Herceptin, RO0452317
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Trastuzumab Emtansine
Other Intervention Name(s)
Kadcyla, ado-trastuzumab emtansine, T-DM1, RO5304020
Intervention Description
Trastuzumab emtansine will be given at a dose of 3.6 mg/kg by intravenous (IV) infusion, once every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Investigator's Choice of Chemotherapy
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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 first cycle (Cycle 1 or 5) to last cycle (Cycle 6 or 8) of PH IV or PH FDC SC neoadjuvant treatment (1 cycle is 3 weeks)
Title
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)
Title
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)
Title
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 first cycle (Cycle 1 or 5) to last cycle (Cycle 6 or 8) of PH IV or PH FDC SC neoadjuvant treatment (1 cycle is 3 weeks)
Title
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)
Title
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)
Title
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)
Title
Percentage of Participants Achieving Pathologic Complete Response (pCR)
Description
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.
Time Frame
Post-surgery (up to 27 weeks)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
Number of Participants with Clinical Laboratory Test Abnormalities During the Neoadjuvant Treatment Phase
Time Frame
From Baseline until surgery (up to 27 weeks)
Title
Number of Participants with Vital Sign Abnormalities During the Neoadjuvant Treatment Phase
Time Frame
From Baseline until surgery (up to 27 weeks)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Disease-specific Inclusion Criteria: Female and male participants with stage II-IIIC early or locally advanced/inflammatory human epidermal growth factor receptor 2-positive (HER2+) breast cancer Primary tumor >2 centimetres (cm) in diameter, or node-positive disease HER2+ breast cancer confirmed by a local laboratory prior to study enrollment. HER2+ status will be determined based on pretreatment breast biopsy material and defined as 3+ by Immunohistochemistry (IHC) and/or positive by HER2 amplification by in situ hybridization (ISH) following American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines 2018 and updates (Wolff et al. Arch Pathol Lab Med 2018) 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 (Allison et al. J Clin Oncol 2020) Agreement to undergo mastectomy or breast conserving surgery after neoadjuvant therapy, including the axillary nodes Availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue block for local confirmation of HER2 and hormone receptor status following current ASCO/CAP guidelines Inclusion Criteria for Treatment with Adjuvant PH FDC SC: Completed the neoadjuvant phase of this study and underwent surgery, and achieved pathologic complete response (pCR), defined as eradication of invasive disease in the breast and axilla according to the current American Joint Committee on Cancer (AJCC) staging system classification, and using the resected specimen by the local pathologist on the basis of guidelines to be provided in a pathology manual Adequate wound healing after breast cancer surgery per investigator's assessment to allow initiation of study treatment within less than or equal to (≤)9 weeks of last systemic neoadjuvant therapy Exclusion Criteria: 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 Treatment with a live vaccine (e.g., FluMist) in the 30 days prior to initiation of study treatment, or anticipation of need for such a vaccine during treatment or within 90 days after the final dose of study treatment 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 Assessment by the investigator as being unable or unwilling to comply with the requirements of the protocol Cancer-specific Exclusion Criteria for Neoadjuvant Phase: Participants who have received any previous systemic therapy for treatment or prevention of breast cancer, or previous chest irradiation for the treatment of cancer 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 with high-risk for breast cancer who have received chemopreventive drugs in the past Participants with multicentric breast cancer, unless all tumors are HER2+ Participants with bilateral breast cancer Participants who have undergone an excisional biopsy of primary tumor and/or axillary lymph nodes Axillary lymph node dissection (ALND) prior to initiation of neoadjuvant therapy Sentinel lymph node biopsy (SLNB) prior to neoadjuvant therapy Exclusion Criterion for Treatment with Adjuvant Trastuzumab Emtansine (Arm E): Current Grade ≥3 peripheral neuropathy (according to the NCI CTCAE v5.0)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: MO43110 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. Only)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Fundación CENIT para la Investigación en Neurociencias
City
Buenos Aires
ZIP/Postal Code
C1125ABD
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro Oncologico Korben; Oncology
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1426AGE
Country
Argentina
Individual Site Status
Recruiting
Facility Name
University Clinical Center of the Republic of Srpska
City
Banja Luka
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Individual Site Status
Recruiting
Facility Name
Cantonal Hospital Zenica; Department for Oncology
City
Zenica
ZIP/Postal Code
72000
Country
Bosnia and Herzegovina
Individual Site Status
Recruiting
Facility Name
Crio - Centro Regional Integrado de Oncologia
City
Fortaleza
State/Province
CE
ZIP/Postal Code
60336-232
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
City
Goiania
State/Province
GO
ZIP/Postal Code
74605-070
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital Moinhos de Vento
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-000
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Hospital Nossa Senhora da Conceicao
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
91350-200
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01317-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Multiprofile Hospital for Active Treatment Uni Hospital; Department of medicinal oncology
City
Panagyurishte
ZIP/Postal Code
4500
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT Dr Georgi Stranski; Medical Oncology Department
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
University Multiprofile Hospital for Active Treatment Sveta Marina Pleven OOD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
DDODIU-Plovdiv, EOOD; Third Internal Department
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
MHAT Nadezhda
City
Sofia
ZIP/Postal Code
1330
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Royal Victoria Regional Health Centre
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Lakeridge Health Oshawa
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Individual Site Status
Recruiting
Facility Name
North York General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2K 1E1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Hopital du Saint Sacrement
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Centro de Estudios Clínicos SAGA
City
Santiago
ZIP/Postal Code
7500653
Country
Chile
Individual Site Status
Recruiting
Facility Name
Clinica Vespucio
City
Santiago
ZIP/Postal Code
8241479
Country
Chile
Individual Site Status
Recruiting
Facility Name
Hospital Metropolitano (Sede Lindora-Santa Ana); Centro de Cancer
City
San Jose
ZIP/Postal Code
10903
Country
Costa Rica
Individual Site Status
Active, not recruiting
Facility Name
Clinica CIMCA
City
San José
ZIP/Postal Code
10103
Country
Costa Rica
Individual Site Status
Active, not recruiting
Facility Name
ICIMED Instituto de Investigación en Ciencias Médicas
City
San José
ZIP/Postal Code
10108
Country
Costa Rica
Individual Site Status
Active, not recruiting
Facility Name
Clinical Hospital Centre Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Max Institute of Cancer Care
City
NEW Delhi Delhi
State/Province
Delhi
ZIP/Postal Code
110024
Country
India
Individual Site Status
Withdrawn
Facility Name
Saifee Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400004
Country
India
Individual Site Status
Recruiting
Facility Name
TATA Medical Centre; Medical Oncology
City
Kolkata
State/Province
WEST Bengal
ZIP/Postal Code
700156
Country
India
Individual Site Status
Recruiting
Facility Name
International Cancer Institute (ICI)
City
Eldoret
ZIP/Postal Code
30100
Country
Kenya
Individual Site Status
Recruiting
Facility Name
Aga Khan University Hospital
City
Nairobi
ZIP/Postal Code
00100
Country
Kenya
Individual Site Status
Recruiting
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Health Pharma Professional Research
City
Cdmx
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
03100
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Iem-Fucam
City
D.f.
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
04980
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Oncologico Potosino
City
San Luis Potosí
State/Province
SAN LUIS Potosi
ZIP/Postal Code
78209
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Instituto Regional de Enfermedades Neoplásicas del Sur; Centro de Inv. de Medicina Oncológica
City
Arequipa
ZIP/Postal Code
5154
Country
Peru
Individual Site Status
Recruiting
Facility Name
Instituto Nacional de Enfermedades Neoplasicas
City
Lima
ZIP/Postal Code
Lima 34
Country
Peru
Individual Site Status
Withdrawn
Facility Name
Oncocenter Peru S.A.C.; Oncosalud
City
Lima
ZIP/Postal Code
Lima 41
Country
Peru
Individual Site Status
Recruiting
Facility Name
Instituto Regional de Enfermedades Neoplasicas - IREN Norte
City
Trujillo
ZIP/Postal Code
13014
Country
Peru
Individual Site Status
Withdrawn
Facility Name
National University Hospital; National University Cancer Institute, Singapore (NCIS)
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Individual Site Status
Withdrawn
Facility Name
National Cancer Centre; Medical Oncology
City
Singapore
ZIP/Postal Code
168583
Country
Singapore
Individual Site Status
Active, not recruiting
Facility Name
Tan Tock Seng Hospital; Oncology
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Medical Oncology Centre of Rosebank; Oncology
City
Johannesburg
ZIP/Postal Code
2196
Country
South Africa
Individual Site Status
Active, not recruiting
Facility Name
Wilgers Oncology Centre
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa
Individual Site Status
Active, not recruiting
Facility Name
University of Pretoria Oncology Department; Medical Oncology
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Individual Site Status
Withdrawn
Facility Name
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Gulhane Training and Research Hospital
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ankara City Hospital; Oncology
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
City
Edirne
ZIP/Postal Code
22770
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ba?c?lar Medipol Mega Üniversite Hastanesi; Oncology
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
City
Sihhiye/Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
For eligible studies, 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/innovation/process/clinical-trials/data-sharing/).

Learn more about this trial

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

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