A multicenter randomized phase III trial to compare trastuzumab (Herceptin®) continuation or discontinuation in combination with 2nd-line chemotherapies after progression on a 1st-line chemotherapy combined with trastuzumab in patients with HER2 positive metastatic breast cancer (Treatment Beyond Progression, TBP) - PANDORA
- Conditions
- Metastacic breast cancerMedDRA version: 8.1Level: LLTClassification code 10027475Term: Metastatic breast cancer
- Registration Number
- EUCTR2006-002860-25-LV
- Lead Sponsor
- Roche Hungary Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 274
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.
6.Disease progression during or after a previous 1st-line chemotherapy* plus trastuzumab treatment as follows:
•Either of taxanes (docetaxel or paclitaxel) + trastuzumab given as 1st-line therapy for palliation
•Other allowed chemotherapy drugs combined with trastuzumab in 1st-line setting: vinorelbine, gemcitabine, capecitabine, platinum compounds, cycylophosphamide, methotrexate, fluorouracil.
7.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.
8.Treatment free interval of trastuzumab between 1st-line and 2nd-line administration is a maximum of 6 weeks.
9.At least 4 weeks since major surgery with full recovery.
10.At least 4 weeks since radiotherapy with full recovery.
11.Complete radiology and tumor measurement work up within 5 weeks prior to randomization.
12.Laboratory: neutrophils count = 1,5 x 109/L, platelet = 100 x 109/L, bilirubin =or< 2 x the upper limit of normal for the institution (ULN), SGOT/SGPT =or<2,5 x ULN or < 5 x ULN for patients with liver metastases, creatinine =or<2.0 mg/dl (within 3 weeks prior to randomization).
13.Left ventricular ejection fraction (LVEF) by cardiac ultrasound or MUGA of =50% within 3 weeks prior to randomization.
14.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 method to avoid pregnancy during the study.
15.ECOG performance status =or<2 and life expectancy =12 weeks (see Appendix 2)
16.Patients must be accessible for treatment and follow-up.
17.Patients entering the trial must be treated and followed at the participating center.
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.Known hypersensitivity reaction to the compounds or incorporated substances or known dihydropyrimidine dehydrogenase deficiency.
2.Concurrent immunotherapy or hormonal therapy (antihormonal, contraceptive or replacement therapy).
3.Anthracyclines as a part of the previous 1st-line chemotherapy or the planned 2nd-line chemotherapy.
4.Known anamnestic history (or present condition) of parenchymal brain 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 chemotherapy plus trastuzumab treatment indicating discontinuation of Herceptin® administration.
8.Serious rest dyspnoe in connection with the advanced malignant process claiming supportive oxygen therapy.
9.Pleural effusion, unless clinically controllable.
10.Serious intercurrent medical conditions that may interfere with the planned treatment (including AIDS, serious active infection, CNS disease, psychiatric illness).
11.History of other malignancy within the last 5 years, which could affect the diagnosis or assessment of breast cancer.
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.
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