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
NCT ID: NCT03674112
Last Updated: 2024-01-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
160 participants
INTERVENTIONAL
2018-12-19
2022-10-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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A: P+H IV Followed by PH FDC SC
In the Treatment Cross-Over Period of the study, participants randomized to Arm A first received pertuzumab IV and trastuzumab IV (P+H IV) administration for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose 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). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
Pertuzumab and Trastuzumab Fixed-Dose Combination for Subcutaneous Administration (PH FDC SC)
PH 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).
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.
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.
B: PH FDC SC Followed by P+H IV
In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles followed by pertuzumab intravenous (IV) and trastuzumab IV (P+H IV) administration for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose 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). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
Pertuzumab and Trastuzumab Fixed-Dose Combination for Subcutaneous Administration (PH FDC SC)
PH 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).
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.
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.
Interventions
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Pertuzumab and Trastuzumab Fixed-Dose Combination for Subcutaneous Administration (PH FDC SC)
PH 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).
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Clinical Centre Nis, Clinic for Oncology
Niš, , Serbia
Hospital General Universitario de Elche; Servicio de Oncologia
Elche, Alicante, Spain
Rocky Mountain Cancer Center - Lakewood (West)
Lakewood, Colorado, United States
Illinois Cancer Care
Peoria, Illinois, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Maryland Oncology Hematology
Rockville, Maryland, United States
Texas Oncology - Dallas Presbyterian Hospital
Dallas, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Texas Oncology - Memorial City
Houston, Texas, United States
USOR - Texas Oncology - San Antonio Northeast
San Antonio, Texas, United States
Texas Oncology- Northeast Texas
Tyler, Texas, United States
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires, , Argentina
Instituto de Câncer E Transplante
Curitiba, Paraná, Brazil
Clinicas Oncologicas Integradas - COI
Rio de Janeiro, Rio de Janeiro, Brazil
Instituto de Ensino e Pesquisa Sao Lucas - IEP
São Paulo, São Paulo, Brazil
Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA
São Paulo, São Paulo, Brazil
Bradford Hill Centro de Investigaciones Clinicas
Recoleta, , Chile
Hospital Hermanos Ameijeiras
La Habana, , Cuba
Instituto Nacional de Oncología y Radiología (INOR)
La Habana, , Cuba
KYS Sadesairaala; Syopatautien poliklinikka
Kuopio, , Finland
VAASAN KESKUSSAIRAALA; Onkologian poliklinikka
Vaasa, , Finland
Princess Margaret Hospital, Oncology; Department of Oncology
Hong Kong, , Hong Kong
Prince of Wales Hosp; Dept. Of Clinical Onc
Shatin, , Hong Kong
King Hussein Cancer Center
Amman, , Jordan
Bellevue Medical Center
El-Metn, , Lebanon
Hammoud Hospital
Saida, , Lebanon
Consultorio Privado (José Luis González Trujillo)
León, Guanajuato, Mexico
Centro Médico Zambrano Hellion
Monterrey, Nuevo León, Mexico
Cuidados oncologicos
Querétaro City, Querétaro, Mexico
Centro Oncológico de Panamá
Panama City, , Panama
Centro Hemato Oncologico Panama
Panama City, , Panama
Hospital da Luz; Departamento de Oncologia Medica
Lisbon, , Portugal
Hospital de Santa Maria; Servico de Oncologia Medica
Lisbon, , Portugal
IPO do Porto; Servico de Oncologia Medica
Porto, , Portugal
National Center for Cancer Care and Research
Doha, , Qatar
King Fahad Medical City; Gastroentrology
Riyadh, , Saudi Arabia
Institute of Oncology and Radiology of Serbia
Belgrade, , Serbia
Hospital Universitario de Canarias;servicio de Oncologia
San Cristóbal de La Laguna, Tenerife, Spain
Sodersjukhuset; Onkologkliniken
Stockholm, , Sweden
Västmanlands sjukhus Västerås, Onkologkliniken
Västerås, , Sweden
Countries
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References
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O'Shaughnessy J, Sousa S, Cruz J, Fallowfield DL, Auvinen P, Pulido C, Cvetanovic A, Wilks S, Ribeiro L, Burotto M, Boulet T, Revelant V, Theron N, Trask P, Wahyudi L, Kirchmayer Machackova Z, Stamatovic L. Long-Term Safety and Efficacy of the Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Injection in Patients With HER2-Positive Early Breast Cancer in PHranceSCa, a Randomized, Open-Label Phase II Study. Clin Breast Cancer. 2025 Aug;25(6):554-559.e1. doi: 10.1016/j.clbc.2025.04.016. Epub 2025 May 3.
O'Shaughnessy J, Sousa S, Cruz J, Fallowfield L, Auvinen P, Pulido C, Cvetanovic A, Wilks S, Ribeiro L, Burotto M, Klingbiel D, Messeri D, Alexandrou A, Trask P, Fredriksson J, Machackova Z, Stamatovic L; PHranceSCa study group. Preference for the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with HER2-positive early breast cancer (PHranceSCa): A randomised, open-label phase II study. Eur J Cancer. 2021 Jul;152:223-232. doi: 10.1016/j.ejca.2021.03.047. Epub 2021 Jun 16.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-002153-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MO40628
Identifier Type: -
Identifier Source: org_study_id
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