Metastacic breast cancer MedDRA version: 8.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer
Conditions
Interventions
Trade Name: Herceptin
Product Name: Herceptin
Product Code: Ro-45-2317
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: trastuzumab
Current Sponsor code: RO-452317
Concentrat
Sponsors
Roche Hungary Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written and signed informed consent prior to beginning specific protocol procedures showing the patients’ willingness and awareness to participate in the trial and comply with its proceedings. 2. Female patients 3. Age =18 years. 4. Pathologically confirmed and documented metastatic breast cancer. 5. Documented HER2-overexpression of the primary or metastatic tumor tissue detected by immunohistochemistry (IHC 3+) and/or genamplification detected by FISH or CISH. 6. Adjuvant treatment with trastuzumab and/or anthracyclines is allowed. 7. Disease progression during or after a previous 1st-line chemotherapy* plus trastuzumab** treatment as follows: • Either of taxanes (docetaxel or paclitaxel) and trastuzumab given as 1st-line therapy for palliation • Other allowed chemotherapy drugs combined with trastuzumab in 1st-line setting: vinorelbine, gemcitabine, capecitabine, platinum compounds, cyclophosphamide, methotrexate, fluorouracil. • Trastuzumab may have been given as monotherapy in the first-line setting if the allowed first-line chemotherapy was discontinued earlier. 8. Patients are scheduled to receive an effective 2nd-line chemotherapy as per standard medication care. Schedule and dose as investigators’ opinion in the best interest of the patients. List of the allowed drugs for the 2nd-line chemotherapy are detailed in Appendix 1. 9. Treatment free interval of trastuzumab between 1st-line and 2nd-line administration is a maximum of 6 weeks. 10. At least 4 weeks since major surgery with full recovery. 11. At least 4 weeks since radiotherapy with full recovery. 12. Complete radiology and tumor measurement work up within 3 weeks prior to randomization. 13. Laboratory: neutrophils count = 1,5 x 109/L, platelet = 100 x 109/L, bilirubin = 50% within 3 weeks prior to randomization. 15. If of childbearing potential, pregnancy test – either urine or serum test - is negative within 1 week prior to randomization. In addition the patient agrees to use an effective, but other than hormonal method to avoid pregnancy during the study. 16. ECOG performance status =12 weeks (see Appendix 2) 17. Patients must be accessible for treatment and follow-up. 18. Patients entering the trial must be treated and followed at the participating center. * Ad 1st-line therapy: Schedule and dose as investigators’ opinion in the best interest of the patients. Trastuzumab in combination with either of taxanes is considered as standard 1st-line therapy. Anthracyclines are not allowed in this setting. ** Trastuzumab had to be given for at least 12 weeks in first line setting. 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
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity reaction to the compounds or incorporated substances. 2. Concurrent immunotherapy or hormonal therapy (antihormonal, contraceptive or replacement therapy) is not allowed at study entry. 3. Anthracyclines in combination with trastuzumab as a part of 1st-line treatment or planned anthracycline administration as 2nd-line chemotherapy. 4. Known anamnestic history (or present condition) of brain metastases (including parenchymal and leptomeningeal metastases). 5. Prior history of myocardial infarction within the previous 6 months. 6. Unstable angina pectoris, uncontrolled arrhythmia and cardiac insufficiency (NYHA Class III-IV) at the time of inclusion. 7. Cardiac toxicity during the previous 1st-line treatment indicating discontinuation of Herceptin® administration. 8. Serious rest dyspnoe in connection with the advanced malignant process claiming supportive oxygen therapy. 9. Clinically significant pleural effusion. 10. Serious intercurrent medical conditions that may interfere with the planned treatment (including AIDS, serious active infection, CNS disease, psychiatric illness). 11. History of invasive malignancy (including second primary breast cancer) other than metastatic breast cancer within the last five years which could affect compliance with the protocol or interpretation of results, except for curatively treated: - basal and squamous cell carcinoma of the skin. - in situ carcinoma of the cervix. 12. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening. 13. Pregnant or nursing women. 14. Patients who in opinion of investigator are ineligible for 2nd-line chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the time to disease progression (TTP) in HER2 positive metastatic breast cancer patients treated with trastuzumab in combination with 2nd-line chemotherapy following progression after 1st-line chemotherapy plus trastuzumab treatment. ;Secondary Objective: To evaluate the following in HER2 positive metastatic breast cancer patients treated with trastuzumab in combination with 2nd-line chemotherapy following progression after 1st-line chemotherapy plus trastuzumab treatment: • Objective response rate (ORR) • Clinical benefit rate (CR + PR + SD) • Time to treatment failure (TTF) • Safety • Overall survival (OS) ;Primary end point(s): Time to Disease progression | — |
Countries
Bulgaria, Estonia, Hungary, Latvia, Lithuania
Outcome results
None listed