Phase 2
N=41
Weekly Gemcitabine and Trastuzumab in the Treatment of Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Metastatic Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00193063 ↗Enrolled (actual)
41
Serious AEs
34.2%
Results posted
Mar 2014
Primary outcome: Primary: Overall Response Rate (ORR) — 30 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Trastuzumab (Drug); Gemcitabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SCRI Development Innovations, LLC
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) |
30 | — |
| SECONDARY Progression Free Survival (PFS) |
4 | — |
| SECONDARY Overall Survival (OS) |
21 | — |
Summary
Due to its remarkable activity as salvage treatment in women with metastatic breast cancer as well as the additive activity observed for gemcitabine administered in combination with trastuzumab, the clinical activity of the combination of gemcitabine administered with trastuzumab represents an exciting and ideal combination to further evaluate in Her 2 over-expressing metastatic breast cancer patients.
Eligibility Criteria
Inclusion Criteria
To be included in this study, you must meet the following criteria:
- Her-2 positive metastatic breast cancer confirmed by biopsy
- Measurable disease
- Able to perform activities of daily living without considerable
- No previous chemotherapy with gemcitabine
- No more than one prior chemotherapy regimen for metastatic breast cancer
- Adequate bone marrow, liver and renal function
- Normal heart function
- Give written informed consent prior to entering this study.
Exclusion Criteria
You cannot participate in this study if any of the following apply to you:
- Received previous treatment with gemcitabine
- History of brain metastases
- Serious underlying medical conditions
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Data sourced from ClinicalTrials.gov (NCT00193063). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.