Phase 2
Completed N=225
A Study of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Advanced and/or Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT02748213 ↗Enrolled (actual)
225
Serious AEs
46.4%
Results posted
Nov 2016
Primary outcomePrimary: Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) — 70.5; 72.7 percentage of participants — p=0.717
Summary
This study will assess the efficacy and safety of intravenous (IV) trastuzumab (Herceptin) and IV docetaxel (Taxotere), with or without oral capecitabine (Xeloda), in women with previously untreated HER2-positive advanced and/or metastatic breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) |
70.5; 72.7 | 0.717 |
| SECONDARY Percentage of Participants With Death or Disease Progression According to RECIST |
67.9; 77.3 | — |
| SECONDARY Progression-Free Survival (PFS) According to RECIST |
17.9; 12.8 | 0.0449 sig |
| SECONDARY Percentage of Participants Who Died |
35.7; 41.8 | — |
| SECONDARY Overall Survival (OS) |
43.5; 47.3 | 0.4758 |
| SECONDARY Duration of Response (DOR) According to RECIST |
15.9; 13.4 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed, HER2-positive advanced and/or metastatic breast cancer not amenable to curative therapy
- At least one measurable lesion according to RECIST
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Baseline left ventricular ejection fraction (LVEF) at least 50%
Exclusion Criteria
- Pregnant, lactating, or women of childbearing potential who are not surgically sterile or not willing to use adequate contraceptive methods
- Previous treatment with Herceptin or other anti-HER therapies, or any previous chemotherapy for advanced or metastatic disease
- Past medical history significant for any cardiac or central nervous system (CNS) disorders
- Poor hematologic, renal, or hepatic function
- Chronic corticosteroid therapy
Data sourced from ClinicalTrials.gov (NCT02748213). 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.