Status:
COMPLETED
A Study of the Efficacy and Safety of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) vs. Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This was a Phase II, randomized, multicenter, international, 2-arm, open-label clinical trial designed to explore the efficacy and safety of trastuzumab emtansine (T-DM1) relative to the combination o...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed adenocarcinoma of the breast with locally advanced or metastatic disease, and a candidate for chemotherapy.
- Human epidermal growth factor receptor 2 (HER2)-positive.
- No prior chemotherapy for their metastatic breast cancer (MBC).
- Measurable disease.
- Age ≥ 18 years.
- For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of contraception or 2 effective forms of non-hormonal contraception by the patient and/or partner. Contraception use must continue for the duration of study treatment and for at least 6 months after the last dose of study treatment. Male patients whose partners are pregnant should use condoms for the duration of the study.
Exclusion
- History of any chemotherapy for MBC.
- An interval of \< 6 months from the completion of cytotoxic chemotherapy in the neo-adjuvant or adjuvant setting until the time of metastatic diagnosis.
- Trastuzumab ≤ 21 days prior to randomization.
- Hormone therapy \< 7 days prior to randomization.
- Current peripheral neuropathy of Grade ≥ 3.
- History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with a similar outcome as those previously mentioned.
- Previous radiotherapy for the treatment of unresectable, locally advanced or metastatic breast cancer is not allowed if more than 25% of marrow-bearing bone has been irradiated or the last fraction of radiotherapy has been administered within approximately 3 weeks prior to randomization.
- Brain metastases that are untreated, symptomatic, or require therapy to control symptoms or any radiation, surgery, or other therapy to control symptoms from brain metastases within 2 months prior to randomization.
- History of exposure to the following cumulative doses of anthracyclines: Doxorubicin or liposomal doxorubicin \> 500 mg/m\^2; epirubicin \> 900 mg/m\^2; mitoxantrone \> 120mg/m\^2 and idarubicin \> 90 mg/m\^2.
- Current unstable angina.
- History of symptomatic congestive heart failure, or ventricular arrhythmia requiring treatment.
- History of myocardial infarction within 6 months prior to randomization.
- Left ventricular ejection fraction (LVEF) below 50% within approximately 28 days prior to randomization.
- History of decreased LVEF or symptomatic congestive heart failure (CHF) with previous adjuvant trastuzumab treatment.
- Cardiac troponin I ≥ 0.2 ng/mL within 28 days of randomization.
- Severe dyspnea at rest because of complications of advanced malignancy or requiring current continuous oxygen therapy.
- Current severe, uncontrolled systemic disease (eg, clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures).
- Major surgical procedure or significant traumatic injury within approximately 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment.
- Current pregnancy or lactation.
- History of receiving any investigational treatment within approximately 28 days prior to randomization.
- Current known infection with human immunodeficiency virus (HIV), active hepatitis B and/or hepatitis C virus.
- History of intolerance (including Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab, murine proteins, or docetaxel.
- Known hypersensitivity to any of the study drugs, including the excipients, or any drugs formulated in polysorbate 80.
- Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT00679341
Start Date
September 1 2008
End Date
May 1 2012
Last Update
January 9 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.