N/A
Completed N=160
An Observational Study of Patients With HER2-Positive Metastatic or Locally Advanced Breast Cancer Treated With Herceptin (Trastuzumab) in 1st Line and Without Progression For 3 Years
Source: ClinicalTrials.gov NCT01480674 ↗Enrolled (actual)
160
Serious AEs
4.5%
Results posted
Feb 2016
Primary outcomePrimary: Tumor Hormone Receptor Status of Participants Without Progression — 57.6; 42.4 Percentage of participants
Summary
This observational study will characterize retrospectively patients with HER2-positive metastatic or locally advanced breast cancer who had received treatment with Herceptin (trastuzumab) in 1st line and who were without progression for at least three years. Patients will be followed prospectively for one year.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tumor Hormone Receptor Status of Participants Without Progression |
57.6; 42.4 | — |
| PRIMARY Percentage of Participants With Prevalence of Bone Metastases Without Progression for at Least 3 Years After the Beginning of 1st Line Herceptin Treatment |
42.5 | — |
| SECONDARY Progression-free Survival |
6.44 | — |
| SECONDARY Time to Progression |
6.44 | — |
| SECONDARY Overall Survival |
NA | — |
| SECONDARY Dosage Schedule of Herceptin Treatment |
40; 2; 82; 1; 10; 1 | — |
| SECONDARY Number of Participants With Antineoplastic Treatment in Combination With Trastuzumab and After Discontinuation of Trastuzumab Treatment |
117; 50; 22; 4 | — |
| SECONDARY Number of Participants With Any Adverse Events and Serious Adverse Events |
30; 6 | — |
| SECONDARY The Duration of Treatment of Trastuzumab |
4.89; 5.57 | — |
Eligibility Criteria
Inclusion Criteria
- Female patients, >/= 18 years of age
- HER2-positive metastatic breast cancer or locally advanced breast cancer
- Systemic treatment included Herceptin as 1st line therapy
- Without progression for at least 3 years after the beginning of Herceptin treatment
- Alive or not alive and treated or not treated with Herceptin at the time of inclusion
Exclusion Criteria
- Disease progression <3 years after beginning 1st-line therapy with Herceptin
Data sourced from ClinicalTrials.gov (NCT01480674). 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.