EUCTR2008-004013-94-GB
Active, not recruiting
Phase 1
A prospective Phase II study to evaluate alterations in molecular biomarkers in HER2-positive metastatic breast cancer together with assessment of trastuzumab use beyond progression after initial exposure to trastuzumab-taxane based treatment - SHERsig
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- F. Hoffmann-La Roche Ltd.
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Written and signed informed consent prior to beginning protocol\-specific procedures.
- •2\. Female patients age \=18 years.
- •3\. Evaluable with or without measurable metastatic breast cancer and at least one metastatic lesion which is amenable to multiple core biopsies.
- •4\. HER2\-positive metastatic lesion, defined as IHC3\+ and/or ISH positive (FISH, CISH or SISH), as confirmed by the central laboratory testing.
- •5\. All tumor biopsy material can be made available for central laboratory testing.
- •6\. ECOG performance status \= 2\.
- •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
Exclusion Criteria
- •Prior or Current Treatments
- •1\. Prior chemotherapy for metastatic disease.
- •2\. Prior trastuzumab\-based therapy for metastatic breast cancer.
- •3\. Prior therapy with capecitabine.
- •4\. Prior adjuvant/neoadjuvant trastuzumab, or adjuvant bevacizumab or tyrosine kinase inhibitor (TKI) completed \<6 months prior to first study treatment.
- •5\. Prior doxorubicin \>360 mg/m2 or epirubicin 720 mg/m2 or equivalent.
- •6\. Prior adjuvant taxane completed \<12 months prior to first study treatment.
- •7\. Biopsy of metastatic or breast lesion with fine needle aspiration only.
- •8\. CNS disease as the only site of metastatic disease.
- •9\. Use of immunotherapy or biological anticancer therapy within 21 days prior to study entry.
Outcomes
Primary Outcomes
Not specified
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