Phase 2 N=225 Randomized Treatment

A Study of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Advanced and/or Metastatic Breast Cancer

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02748213 ↗

Enrolled (actual)

225

Serious AEs

46.4%

Results posted

Nov 2016

Primary outcome: 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 percentage of participants — p=0.717

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Xeloda (Drug); Taxotere (Drug); Herceptin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Hoffmann-La Roche
Primary completion: Mar 2006

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	—

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.

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

View full record on ClinicalTrials.gov →

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.