A 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
- Conditions
- Human epidermal growth factor receptor 2 (HER2)-positive Early Breast Cancer.MedDRA version: 20.0Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-002153-30-ES
- Lead Sponsor
- Roche Farma S.A.(Soc Uni) que realiza el ensayo en España y que actúa como representante de F. Hoffmann-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
Disease-specific criteria
- Female or male with histologically confirmed, HER2+ inflammatory, locally advanced or early-stage breast cancer who have received neoadjuvant Perjeta + Herceptin and have completed neoadjuvant chemotherapy and subsequently undergone surgery for their breast cancer
Note: The neoadjuvant chemotherapy regimen (including type and sequencing of selected agents) and the number of neoadjuvant Perjeta and Herceptin treatment cycles are at the discretion of the treating physician and patient. Subcutaneously administered Herceptin may have been used in the neoadjuvant setting. The use of any trastuzumab biosimilars in the neoadjuvant setting is not allowed
- 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-positive 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 < two 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
- Age >= 18 years
- Ability to comply with the study protocol, in the investigator’s judgment
- Eastern Cooperative Oncology Group performance status 0 or 1
- Intact skin at planned site of subcutaneous injections (thigh)
- Left ventricular ejection fraction (LVEF) >= 55% measured by echocardiogram or multiple-gated acquisition scan within 28 days of study entry
- 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 mu
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method