A Study to Compare Pertuzumab + Trastuzumab + Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
iOMEDICO AG
With
Arbeitsgemeinschaft fur Internistische Onkologie
Amgen
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Signed and dated written informed consent prior to beginning of protocol-specific procedures.
Histologically or cytologically confirmed adenocarcinoma of the breast. Locally advanced and inoperable or metastatic disease.
HER2-positive disease, defined as IHC status HER2+++ or CISH/FISH status positive.
Female patients aged ≥ 18 years.
In case of adjuvant treatment, disease-free interval of at least 12 months after completion of adjuvant treatment (excluding hormonal therapy).
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Left Ventricular Ejection Fraction (LVEF) ≥ 50%.
For women with childbearing potential, defined as physiologically capable of becoming pregnant:
* Negative pregnancy test.
* Agreement to use an effective form of contraception during study treatment and for 7 months after the last dose of study treatment.
Life expectancy of at least 12 weeks.
Adequate organ and bone marrow function
Fluent in spoken and written German and willing to answer the questionnaires
You may not be if
Previous systemic treatment in palliative intention (chemotherapy, hormonal therapy and / or biological therapy)
Persistent peripheral sensory or motor neuropathy grade 2 or higher (NCI CTCAE v5.0)
Evidence of central nervous system metastases. CT or MRI of the brain is only mandatory in case of clinical suspicion of brain metastases
Current uncontrolled hypertension (systolic \> 150 mmHg and / or diastolic \> 100 mmHg) or clinically significant cardiovascular disease
History of LVEF \< 50% during or after prior (neo)adjuvant therapy with trastuzumab
Current severe, uncontrolled systemic disease (e.g. cardiovascular, pulmonary, or metabolic disease, wound healing disorder, ulcers, or bone fractures, or severe fungal, bacterial or viral infection)
Major surgery within 28 days prior to start of study medication, or anticipation of the need for major surgery during the course of study treatment
Current known infection with HIV, HBV, or HCV (testing not required)
Dyspnea at rest due to complications of advanced malignancy, or other diseases requiring continuous oxygen therapy.
Known hypersensitivity to any of the study medications or to excipients of recombinant human or humanized antibodies.
Participation in investigational studies within 30 days or five half-lives of the respective IMP, whichever is longer, prior randomization.
Pregnant or lactating women.
Clareo Health | A Study to Compare Pertuzumab + Trastuzumab + Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer
