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A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer

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ClinicalTrials.gov Identifier: NCT03674112
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This is a Phase II, randomized, multicentre, multinational, open-label, cross-over study in adult patients who have completed neoadjuvant chemotherapy with neoadjuvant pertuzumab and trastuzumab and have undergone surgical treatment of human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. The study will consist of two adjuvant treatment periods: a treatment cross-over period and a treatment continuation period. It will evaluate participant-reported preference for a subcutaneously administered fixed-dose combination formulation (FDC SC) of pertuzumab and trastuzumab compared with intravenously (IV) administered pertuzumab and trastuzumab formulations. The study will also evaluate participant-reported satisfaction with pertuzumab and trastuzumab FDC SC and health-related quality of life outcomes; healthcare professionals' perceptions of time/resource use and convenience of pertuzumab and trastuzumab FDC SC compared with pertuzumab and trastuzumab IV formulations; as well as the safety and efficacy of each study regimen.

Condition or disease Intervention/treatment Phase
HER2-Positive Early Breast Cancer Drug: Pertuzumab and Trastuzumab FDC SC Drug: Pertuzumab IV Drug: Trastuzumab IV Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Open-Label Cross-Over Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Patients With HER2-Positive Early Breast Cancer
Actual Study Start Date : December 19, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : October 4, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: A: Pertuzumab and Trastuzumab - IV Followed by FDC SC
In the Treatment Cross-Over Period of the study, participants randomized to Arm A will first receive pertuzumab IV and trastuzumab IV for 3 treatment cycles followed by pertuzumab and trastuzumab FDC SC for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants will choose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment).
Drug: Pertuzumab and Trastuzumab FDC SC
Pertuzumab and Trastuzumab FDC SC will be administered subcutaneously (SC) at a fixed non-weight-based dose. A loading dose of 1200 mg pertuzumab and 600 mg trastuzumab is then followed by a maintenance dose of 600 mg pertuzumab and 600 mg trastuzumab once every 3 weeks (Q3W).
Other Name: RO7198574

Drug: Pertuzumab IV
Pertuzumab will be administered intravenously (IV) as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose Q3W.
Other Name: Perjeta

Drug: Trastuzumab IV
Trastuzumab will be administered intravenously (IV) as an 8-mg/kg IV loading dose and then 6 mg/kg IV maintenance dose Q3W.
Other Name: Herceptin

Experimental: B: Pertuzumab and Trastuzumab - FDC SC Followed by IV
In the Treatment Cross-Over Period of the study, participants randomized to Arm B will first receive pertuzumab and trastuzumab FDC SC for 3 treatment cycles followed by pertuzumab IV and trastuzumab IV for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants will choose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment).
Drug: Pertuzumab and Trastuzumab FDC SC
Pertuzumab and Trastuzumab FDC SC will be administered subcutaneously (SC) at a fixed non-weight-based dose. A loading dose of 1200 mg pertuzumab and 600 mg trastuzumab is then followed by a maintenance dose of 600 mg pertuzumab and 600 mg trastuzumab once every 3 weeks (Q3W).
Other Name: RO7198574

Drug: Pertuzumab IV
Pertuzumab will be administered intravenously (IV) as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose Q3W.
Other Name: Perjeta

Drug: Trastuzumab IV
Trastuzumab will be administered intravenously (IV) as an 8-mg/kg IV loading dose and then 6 mg/kg IV maintenance dose Q3W.
Other Name: Herceptin




Primary Outcome Measures :
  1. Percentage of Participants Who Indicated They Preferred the Pertuzumab and Trastuzumab Fixed-Dose Combination Subcutaneous (FDC SC) Administration as Assessed in Question 1 of the Patient Preference Questionnaire [ Time Frame: Cycle 6 Day 1 (each cycle is 21 days) ]

Secondary Outcome Measures :
  1. Participant-Assessed Satisfaction with Pertuzumab and Trastuzumab FDC SC, Based on Responses to Question 1 of the Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) [ Time Frame: Cycle 3 Day 1, Cycle 6 Day 1 (each cycle is 21 days) ]
  2. Participant-Assessed Satisfaction with Pertuzumab and Trastuzumab IV, Based on Responses to Question 1 of the Therapy Administration Satisfaction Questionnaire - Intravenous (TASQ-IV) [ Time Frame: Cycle 3 Day 1, Cycle 6 Day 1 (each cycle is 21 days) ]
  3. Percentage of Participants Who Select Pertuzumab and Trastuzumab FDC SC for the Study Treatment Continuation Period [ Time Frame: Cycle 7 Day 1 (each cycle is 21 days) ]
  4. Healthcare Professional (HCP) Perception of Time/Resource Use and Convenience of Each Study Regimen, Based on HCP Responses to the Healthcare Professional Questionnaire (HCPQ) - Treatment Room, by Individual Question [ Time Frame: Day 1 of Cycles 1-6 (each cycle is 21 days) ]
  5. Healthcare Professional (HCP) Perception of Time/Resource Use and Convenience of Each Study Regimen, Based on HCP Responses to the HCPQ - Drug Preparation Room, by Individual Question [ Time Frame: Day 1 of Cycles 1-6 (each cycle is 21 days) ]
  6. Change From Baseline Over Time in Health-Related Quality of Life (HRQoL) as Assessed by the Global Health Status/QoL Scale Score of the EORTC QLQ-C30 [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ]
  7. Change From Baseline Over Time in the Physical Functioning Scale Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ]
  8. Change From Baseline Over Time in the Role Functioning Scale Score of the EORTC QLQ-C30 [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ]
  9. Change From Baseline Over Time in the Emotional Functioning Scale Score of the EORTC QLQ-C30 [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ]
  10. Change From Baseline Over Time in the Cognitive Functioning Scale Score of the EORTC QLQ-C30 [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ]
  11. Change From Baseline Over Time in the Social Functioning Scale Score of the EORTC QLQ-C30 [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ]
  12. Change From Baseline Over Time in the Fatigue Scale Score of the EORTC QLQ-C30 [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ]
  13. Change From Baseline Over Time in the Nausea and Vomiting Scale Score of the EORTC QLQ-C30 [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ]
  14. Change From Baseline Over Time in the Pain Scale Score of the EORTC QLQ-C30 [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ]
  15. Change From Baseline Over Time in the Dyspnoea Scale Score of the EORTC QLQ-C30 [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ]
  16. Change From Baseline Over Time in the Insomnia Scale Score of the EORTC QLQ-C30 [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ]
  17. Change From Baseline Over Time in the Appetite Loss Scale Score of the EORTC QLQ-C30 [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ]
  18. Change From Baseline Over Time in the Constipation Scale Score of the EORTC QLQ-C30 [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ]
  19. Change From Baseline Over Time in the Diarrhoea Scale Score of the EORTC QLQ-C30 [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ]
  20. Change From Baseline Over Time in the Financial Difficulties Scale Score of the EORTC QLQ-C30 [ Time Frame: Baseline; Day 1 of Cycles 1, 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years) ]
  21. Percentage of Participants with at Least One Adverse Event [ Time Frame: Up to 3 years ]
  22. Percentage of Participants with at Least One Grade ≥3 Adverse Event, Severity Assessed According to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0) [ Time Frame: Up to 3 years ]
  23. Percentage of Participants with Heart Failure [ Time Frame: Up to 3 years ]
    Heart failure severity will be assessed by the New York Heart Association (NYHA) Classification System For Heart Failure and the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).

  24. Percentage of Participants with Left Ventricular Ejection Fraction (LVEF) Decreases of At Least 10 Percentage Points From Baseline and to Below 50% [ Time Frame: Baseline; Day 1 of Cycles 4, 7, and 11 (each cycle is 21 days); End of Treatment and Follow-Up visits (up to 3 years) ]
  25. Percentage of Participants who Withdraw Prematurely from Study Treatment [ Time Frame: Up to 1 year ]
  26. Percentage of Participants with an Adverse Event of Abnormal Targeted Vital Signs [ Time Frame: Up to 3 years ]
  27. Percentage of Participants with an Adverse Event of Abnormal Physical Examination Findings [ Time Frame: Up to 3 years ]
  28. Percentage of Participants with an Adverse Event of Abnormal Targeted Clinical Laboratory Test Results [ Time Frame: Up to 3 years ]
  29. Kaplan-Meier Estimate of the Percentage of Participants in Invasive Disease-Free Survival [ Time Frame: Up to 3 years ]
  30. Kaplan-Meier Estimate of the Percentage of Participants in Invasive Disease-Free Survival Including Second Primary Non-Breast Cancer [ Time Frame: Up to 3 years ]
  31. Kaplan-Meier Estimate of the Percentage of Participants in Distant Disease-Free Survival [ Time Frame: Up to 3 years ]
  32. Kaplan-Meier Estimate of the Percentage of Participants in Overall Survival [ Time Frame: Up to 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Disease-specific criteria:

  • Female or male with histologically confirmed, HER2-positive (HER2+) inflammatory, locally advanced or early-stage breast cancer who have received neoadjuvant pertuzumab and trastuzumab and have completed neoadjuvant chemotherapy and subsequently undergone surgery for their breast cancer.
  • HER2+ breast cancer assessed at the local laboratory prior to initiation of neoadjuvant therapy. HER2+ status must be determined based on breast biopsy material obtained prior to neoadjuvant treatment and is defined as 3+ by immunohistochemistry (IHC) and/or positive by HER2 amplification by in situ hybridization (ISH) with a ratio of ≥2 for the number of HER2 gene copies to the number of chromosome 17 copies.
  • Hormone receptor status of the primary tumour determined by local assessment. Hormone receptor status may be either positive or negative.
  • Completed all neoadjuvant chemotherapy and surgery. Adjuvant radiotherapy may be planned or ongoing at study entry and adjuvant hormone therapy is allowed during the study. Note that study treatment cannot be initiated within <2 weeks of surgery but must be initiated ≤9 weeks from the last administration of systemic neoadjuvant therapy.
  • No evidence of residual, locally recurrent or metastatic disease after completion of surgery. Patients with clinical suspicion of metastases must undergo radiological assessments per institutional practice to rule out distant disease.
  • Wound healing after breast cancer surgery adequate per investigator's assessment to allow initiation of study treatment within ≤9 weeks of last systemic neoadjuvant therapy
  • No adjuvant chemotherapy planned. Note that adjuvant hormonal treatment is allowed during the study.

General criteria:

  • Ability to comply with the study protocol, in the investigator's judgment
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Intact skin at planned site of subcutaneous injections (thigh)
  • Left ventricular ejection fraction (LVEF) ≥55% measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan within 28 days of study randomization
  • No major surgical procedure unrelated to breast cancer within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment
  • For women of childbearing potential: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating eggs, Women must remain abstinent or use non-hormonal contraceptive methods with a failure rate of <1% per year, or two effective non-hormonal contraceptive methods during the study treatment periods and for 7 months after the last dose of study treatment
  • For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm, men must remain abstinent or use a condom during the study treatment periods and for seven months after the last dose of study treatment to avoid exposing the embryo. Men must refrain from donating sperm during this same period
  • A negative serum pregnancy test must be available prior to randomization for women of childbearing potential

Exclusion Criteria:

Cancer-specific criteria:

  • Stage IV (metastatic) breast cancer
  • Current or prior history of active malignancy within the last five years. Appropriately treated non-melanoma skin cancer; in situ carcinomas, including cervix, colon, or skin; or Stage I uterine cancer within the last five years are allowed
  • Previous systemic therapy for treatment or prevention of breast cancer, except neoadjuvant Perjeta, Herceptin and chemotherapy for current breast cancer

General criteria:

  • Investigational treatment within four weeks of enrolment
  • Serious cardiac illness or medical conditions
  • History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such as structural heart disease, coronary heart disease, clinically significant electrolyte abnormalities, or family history of sudden unexplained death or long QT syndrome
  • Inadequate bone marrow, renal and impaired liver function
  • Current severe, uncontrolled systemic disease that may interfere with planned treatment
  • Pregnant or breastfeeding, or intending to become pregnant during the study or within seven months after the last dose of study treatment. Women of childbearing potential must have a negative serum pregnancy test result within seven days prior to initiation of study treatment
  • Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient'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
  • Concurrent, serious, uncontrolled infections, or known infection with human immunodeficiency virus (HIV)
  • Known hypersensitivity to any of the study drugs, excipients, and/or murine proteins
  • Current chronic daily treatment with corticosteroids

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674112


Contacts
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Contact: Reference Study ID number: MO40628 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03674112     History of Changes
Other Study ID Numbers: MO40628
2018-002153-30 ( EudraCT Number )
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Pertuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents