Phase 4
Completed N=32
A Study of Herceptin (Trastuzumab) in Combination With a Taxane in Participants With HER2-Positive Breast Cancer Who Relapsed After (Neo)Adjuvant Herceptin Treatment
Source: ClinicalTrials.gov NCT01301729 ↗Enrolled (actual)
32
Serious AEs
15.6%
Results posted
Dec 2016
Primary outcomePrimary: Progression-Free Survival (PFS) — 9.9 months
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This single arm, open-label study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with a taxane as first line therapy in participants with HER2-positive breast cancer who relapsed after neoadjuvant or adjuvant Herceptin treatment. Participants will receive Herceptin (loading dose of 4 mg/kg intravenously [iv], 2 mg/kg iv weekly thereafter) with 6 3-week cycles of either docetaxel (100 mg/m2 iv every 3 weeks) or paclitaxel (90 mg/m2 every week). Herceptin treatment will be continued until disease progression or unacceptable toxicity occurs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
9.9 | — |
| SECONDARY Overall Response Rate |
81.3 | — |
| SECONDARY Duration of Response |
9.8 | — |
| SECONDARY Overall Survival |
NA | — |
| SECONDARY Percentage of Participants With an Adverse Event (AE) |
93.8 | — |
| SECONDARY Determination of Biomarkers Indicative for Response (Serum and Tumour Tissue Analyses) |
— | — |
| SECONDARY Clinical Benefit Rate |
81.3 | — |
| SECONDARY Time to Progression |
9.9 | — |
Eligibility Criteria
Inclusion Criteria
- Female participants , >/= 18 years of age
- Locally recurrent/metastatic breast cancer (relapse in supra- or infraclavicular lymph nodes is regarded as metastatic disease)
- HER2-positive primary disease
- Participants must have received Herceptin in the adjuvant and/or neoadjuvant setting
- Relapsed breast cancer >/= 6 months after discontinuing last drugs of Herceptin and/or chemotherapy in the adjuvant and/or neoadjuvant setting for HER2-positive breast cancer
- Measurable disease according to RECIST 1.0
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Maximum cumulative dose of doxorubicin </= 360 mg/m2 or of epirubicin </= 720 mg/m2 or no prior anthracyclines
- At least 3 weeks after prior surgery or radiotherapy
Exclusion Criteria
- Pregnant or breastfeeding women
- Previous chemotherapy for metastatic breast cancer (prior endocrine therapy till progressive disease is allowed)
- Pleural effusions, ascites or bone lesions as only manifestation of disease
- Brain metastases
- Invasive malignancy other than metastatic breast cancer
- Inadequate bone marrow, hepatic or renal function
- Prior treatment with anti-HER therapies other than (neo)adjuvant Herceptin
Data sourced from ClinicalTrials.gov (NCT01301729). 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. Informational only — not medical advice.