Status:
WITHDRAWN
A Study to Compare Pertuzumab + Trastuzumab + Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer
Lead Sponsor:
iOMEDICO AG
Collaborating Sponsors:
Arbeitsgemeinschaft fur Internistische Onkologie
Amgen
Conditions:
Advanced Breast Cancer
HER2-positive Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
This is a randomized, open-label, two-arm, phase III trial in Germany to investigate whether vinorelbine-based triple combination presents a less toxic treatment option than docetaxel-based triple com...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03811418
Start Date
January 1 2019
End Date
April 1 2019
Last Update
November 26 2019
Active Locations (1)
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1
iOMEDICO AG
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106