A Phase III Randomized, Controlled Trial of Myocet, Trastuzumab and Paclitaxel versus Trastuzumab and Paclitaxel for First line Therapy of Metastatic Breast Cancer
- Conditions
- HER2+ Metastatic Breast CancerMedDRA version: 8.1Level: lltClassification code 10027475
- Registration Number
- EUCTR2005-006109-19-DE
- Lead Sponsor
- Sopherion Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 332
1. Women 18 years of age or older
2. Adenocarcinoma of the breast that is histologically or cytologically proven to show HER2 gene amplification positivity by fluorescence in situ hybridization (FISH)
3. Metastatic disease, using the American Joint Committee on Cancer staging criteria
4. No prior chemotherapy for metastatic disease. Prior chemotherapy in adjuvant or neo-adjuvant setting is allowed if completed at least 1 year earlier. Prior adjuvant or neo-adjuvant chemotherapy within 12 months is allowed, if completed > 4 weeks previously and if it did NOT include anthracyclines or taxanes or prior trastuzumab. Patients must not have received a cumulative dose of doxorubicin of greater than 300 mg/m2 or epirubicin of greater than 600 mg/m2.
5. Prior hormonal therapy is allowed in either the metastatic or adjuvant setting, but must be discontinued prior to first study drug administration.
6. At least one lesion that is measurable in one dimension (RECIST). Patients may have non-measurable disease as long as they have at least one measurable lesion.
7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Appendix B) and an anticipated life expectancy of >6 months
8. Adequate bone marrow function:
• Absolute neutrophil count (ANC)> 2,000/mm3
• Platelet count > 100,000/mm3
• Hemoglobin > 10 g/dL
9. Adequate liver and kidney function:
• Total bilirubin within normal limits for the institution
• Aspartate aminotransferase (AST, SGOT) < 3 x ULN (or = 5 ×ULN in presence of metastatic liver disease)
• Alanine aminotransferase (ALT, SGPT) < 3 x ULN ( or = 5 × ULN in presence of metastatic liver disease)
• Serum creatinine < 2.0 mg/dL
• Alkaline Phosphatase < 3 x ULN in the absence of bone metastases. If > 3 ×ULN in the presence of metastatic liver disease, or attributable to bone metastases, patients will be eligible.
10. Left ventricular ejection fraction (LVEF) within institutional normal range measured by MUGA or echocardiogram with MUGA being the preferred method. Note: with either method, the results will be centrally reviewed in a blinded fashion. Eligibilty is based on site’s initial reading.
11. Negative serum or urine ß-hCG pregnancy test for women of childbearing potential within 7 days of study drug administration (i.e., women who are not surgically sterile or more than 2 years post-menopausal).
12. Adequate birth control measures by women of childbearing potential to prevent pregnancy during the study.
13. At least 4 weeks since major surgery, 3 weeks since radiotherapy, and discontinued hormone therapy (tamoxifen or aromatase inhibitors).
14. Written, signed and dated, informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Prior chemotherapy or other systemic therapy other than hormonal therapy for metastatic disease
2. Active, unresolved infection
3. Prior adjuvant therapy with doxorubicin > 300 mg/m2 or epirubicin > 600 mg/m2
4. Patients who develop metastatic disease = 12 months after completing adjuvant trastuzumab (Herceptin), paclitaxel, docetaxel, or doxorubicin/epirubicin are considered to have had prior therapy for metastatic disease and are excluded from study participation.
5. Receiving concurrent hormonal therapy.
6. Prior radiation therapy ending less than three weeks before the start of study therapy
7. Prior radiation therapy to the mediastinal area >3,500 cGy, or radiation to > 25% of the bone marrow
8. Symptomatic brain metastases including patients requiring corticosteroid treatment or anti-convulsant medications for control of symptoms
9. Active cardiac disease
• Any prior myocardial infarction
• Current or history of documented congestive heart failure (CHF)
• Current use of digitalis glycosides or ACE inhibitors for CHF, Note: ACE inhibitors can be used for hypertension
• Any prior history of arrhythmia or cardiac valvular disease requiring medications or considered clinically significant (e.g., under the care of a cardiologist)
• Current use of medications for treatment of arrhythmias or angina pectoris
• Current uncontrolled hypertension (diastolic >100 mmHg or systolic > 200 mmHg)
• Clinically significant pericardial effusion
10. Prior malignancy within 5 years, except carcinoma in situ of the cervix or non-melanoma skin cancer
11. Women who are pregnant or breast feeding
12. Women of childbearing potential or sexual partner unwilling to employ adequate contraception
13. History of hypersensitivity reaction to anthracyclines, trastuzumab, benzyl alcohol, G-CSF, Cremophor, eggs, or egg products
14. Investigational agent(s) within 3 weeks of start of study therapy
15. Known HIV infection
16. Receiving any other standard or investigational treatment for cancer, or any other investigational agent for any indication
17. Any concurrent medical or psychological condition that would limit the ability of the patient to provide informed consent or to comply with the obligations of the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method