A multicenter single arm phase II trial of trastuzumab (Herceptin®) continuation 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

Roche Hungary Ltd.0 sites120 target enrollmentNovember 17, 2006

Overview

No summary available.

Registry

who.int

Start Date

November 17, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

Roche Hungary Ltd.

•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) \+ 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 continued as monotherapy in the first\-line setting if the allowed first\-line chemotherapy was discontinued earlier.

•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\.Pleural effusion.
•10\.Serious intercurrent medical conditions that may interfere with the planned treatment (including AIDS, serious active infection, CNS disease, psychiatric illness).