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Eine Studie zu Trastuzumab-Emtansin bei Patientinnen mit HER2-positivem Brustkrebs (HER2: humaner epidermaler Wachstumsfaktor-Rezeptor-2), die zuvor eine Anti-HER2- und Chemotherapie-basierte Behandlung erhalten haben
A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment
Krebs Brustkrebs
Basisinformationen
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Studien-ID
NCT01702571, MO28231, 2012-001628-37
Condition
Breast Cancer
Official Title
A Two-Cohort, Open-Label, Multicenter Study of Trastuzumab Emtansine (T-DM1) in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients Who Have Received Prior Anti-HER2 and Chemotherapy-Based Treatment
Einschlusskriterien
All
≥18 Years
No
Inclusion Criteria
- HER2-positive disease determined locally
- Histologically or cytologically confirmed invasive breast cancer
- Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced or metastatic setting must include both chemotherapy, alone or in combination with another agent, and an anti-HER2 agent, alone or in combination with another agent
- Documented progression of incurable, unresectable, LABC, or mBC, defined by the investigator: progression must occur during or after most recent treatment for LABC/mBC or within 6 months of completing adjuvant therapy
- Measurable and/or non-measurable disease
- Left ventricular ejection fraction (LVEF) >/=50% by either echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2
- Adequate organ function
- Use of highly effective contraception as defined by the protocol
Exclusion Criteria
- History of treatment with trastuzumab emtansine
- Prior enrollment into a clinical study containing trastuzumab emtansine regardless of having received trastuzumab emtansine or not
- Peripheral neuropathy of Grade >/= 3 per National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) v 4.0
- History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive breast cancer
- History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to first study treatment except hormone therapy, which can be given up to 7 days prior to first study treatment; recovery of treatment-related toxicity consistent with other eligibility criteria
- History of exposure to cumulative doses of anthracyclines
- History of radiation therapy within 14 days of first study treatment. The participant must have recovered from any resulting acute toxicity (to Grade </=1) prior to first study treatment.
- Metastatic central nervous system (CNS) disease only
- Brain metastases which are symptomatic
- History of a decrease in LVEF to less than (<) 40% or symptomatic congestive heart failure (CHF) with previous trastuzumab treatment
- History of symptomatic CHF (New York Heart Association [NYHA] Classes II-IV) or serious cardiac arrhythmia requiring treatment
- History of myocardial infarction or unstable angina within 6 months of first study treatment
- Current dyspnea at rest due to complications of advanced malignancy or requirement for continuous oxygen therapy
- Current severe, uncontrolled systemic disease (clinically significant cardiovascular, pulmonary, or metabolic disease)
- Pregnancy or lactation
- Currently known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus
- History of intolerance (such as Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins or any component of the product
Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden für Laien bearbeitet.
Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden nicht geändert.
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Studienergebnisse
LPS MO28231 KAMILLA Final Results May 2021 German
(PDF, 0.4 MB)
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