Phase 2
N=173
Cetuximab and Cisplatin in the Treatment of "Triple Negative" (Estrogen Receptor [ER] Negative, Progesterone Receptor [PgR] Negative, and Human Epidermal Growth Factor Receptor 2 [HER2] Negative) Metastatic Breast Cancer
Breast Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT00463788 ↗Enrolled (actual)
173
Serious AEs
29.7%
Results posted
Oct 2012
Primary outcome: Primary: Best Overall Response (BOR) — 20.0; 10.3 percentage of participants — p=0.1109
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cetuximab, cisplatin (Drug); cisplatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Overall Response (BOR) |
20.0; 10.3 | 0.1109 |
| SECONDARY Progression-Free Survival (PFS) Time |
3.7; 1.5 | 0.0324 sig |
| SECONDARY Overall Survival (OS) Time |
12.9; 9.4 | 0.3121 |
| SECONDARY Time to Response (TTR) |
1.4; 1.3 | 0.5993 |
| SECONDARY Safety- Number of Participants Experiencing Any Adverse Event (AE) |
114; 57 | — |
Summary
The primary objective of this study is to determine whether overall response to cetuximab combined with cisplatin is better than overall response to cisplatin alone together with showing that the overall response for cetuximab and cisplatin was above a pre-specified threshold of 0.2 in the treatment of "triple negative" metastatic breast cancer.
The secondary objective of this study is to compare the differences between the two treatment groups using the following criteria : Progression-Free Survival (PFS) Time, Overall Survival (OS), Time to Response (TTR) and Safety.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed diagnosis of metastatic breast cancer (Stage IV)
- Estrogen Receptor [ER] negative, PgR negative and HER2 less than 3+ expression by immunohistochemistry (IHC)
- No more than 1 prior chemotherapy received for treating this metastatic breast cancer
- No more than 1 prior anthracycline and/or taxane regimen (either adjuvant or metastatic setting)
- Other protocol-defined inclusion criteria may apply
Exclusion Criteria
- Prior platinum agent
- Prior mitomycin
- Known history of brain metastases
- Other protocol-defined exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00463788). 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.