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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
Bitte beachten Sie, dass der Rekrutierungsstatus der Studie an Ihrem Standort vom Gesamtstatus der Studie abweichen kann, da einige Studienzentren früher rekrutieren als andere.
Status der Studie:
Abgeschlossen
Diese Studie läuft in
Städte
- Augsburg
- Berlin
- bottrop
- Dresden
- Erfurt
- Erlangen
- Hamburg
- Hannover
- Koblenz
- Leverkusen
- München
- Münster
- Offenbach am Main
- Porta Westfalica
- Rostock
- Tübingen
- Wiesbaden
- Würzburg
Studien-ID:
NCT01702571 2012-001628-37 MO28231
Studienzusammenfassung
This two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general participant population; Cohort 2 will include only Asian participants.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT01702571,MO28231,2012-001628-37
Studien-ID
Trastuzumab Emtansine
Treatments
Breast Cancer
Condition
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
Gender
≥18 Years
Age
No
Healthy Volunteers
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
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