Phase 2
N=109
A Study of Herceptin (Trastuzumab) in Combination With 2nd-Line Chemotherapy in Patients With HER2 Positive Metastatic Breast Cancer.
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00444587 ↗Enrolled (actual)
109
Serious AEs
20.2%
Results posted
Jun 2016
Primary outcome: Primary: Median Time to Disease Progression — 171; 171 Days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Second line chemotherapy (Drug); trastuzumab [Herceptin] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Time to Disease Progression |
171; 171 | — |
| SECONDARY Objective Response Rate |
43.7; 43.7 | — |
| SECONDARY Clinical Benefit Rate |
75.9; 72.4 | — |
| SECONDARY Median Time to Treatment Failure |
154 | — |
| SECONDARY Overall Survival |
717 | — |
| SECONDARY Number of Participants With Any Adverse Events and Serious Adverse Events |
84; 10; 20; 2 | — |
| SECONDARY Biochemistry Safety Laboratory Parameters: Mean Serum Glutamic Oxaloacetic Transaminase, Serum Glutamic-pyruvic Transaminase and Alkali Phosphatase Levels |
31.46; 36.16; 25.86; 28.19; 202.30; 193.49 | — |
| SECONDARY Biochemistry Safety Laboratory Parameters: Mean Total Bilirubin and Serum Creatinine Levels |
13.50; 19.16; 81.18; 82.53 | — |
| SECONDARY Biochemistry Safety Laboratory Parameters: Mean Albumin Levels |
43.99; 41.07 | — |
| SECONDARY Biochemistry Safety Laboratory Parameters: Mean Urea, Sodium and Potassium Levels |
6.33; 6.92; 140.58; 139.16; 4.40; 4.22 | — |
| SECONDARY Hematology Safety Laboratory Parameters: Mean Hemoglobin Levels |
12.67; 11.00 | — |
| SECONDARY Hematology Safety Laboratory Parameters: Mean Total Leukocytes Counts |
8.00; 7.53 | — |
| SECONDARY Hematology Safety Laboratory Parameters: Percent of Differential for Neutrophils, Basophils, Eosinophils, Lymphocytes and Monocytes Counts |
64.89; 62.22; 0.38; 1.28; 2.36; 2.50 | — |
| SECONDARY Hematology Safety Laboratory Parameter: Mean Platelets Counts |
263.14; 256.64 | — |
| SECONDARY Mean Left Ventricular Ejection Fraction |
63.3; 62.6; 61.2; 68.6 | — |
Summary
This 2 arm study will compare the efficacy and safety of continuation or discontinuation of Herceptin treatment in combination with 2nd line chemotherapy, in patients with HER2 positive metastatic breast cancer whose condition has progressed on 1st line chemotherapy plus Herceptin. Patients will be randomized either to continue or discontinue Herceptin treatment (6mg/kg iv infusion every 3 weeks) while receiving second-line chemotherapy of the investigator's choice. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Eligibility Criteria
Inclusion Criteria
- female patients, >= 18 years of age;
- metastatic breast cancer;
- HER2 overexpression (IHC 3+ and/or FISH positive);
- disease progression during or after previous 1st line chemotherapy + Herceptin;
- scheduled to receive 2nd line chemotherapy.
Exclusion Criteria
- concurrent immunotherapy or hormonal therapy;
- anthracyclines as part of previous 1st line chemotherapy or planned 2nd line chemotherapy;
- cardiac toxicity during previous 1st line chemotherapy + Herceptin;
- history of other malignancy within last 5 years.
Data sourced from ClinicalTrials.gov (NCT00444587). 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.