Phase 2
Completed N=138
Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT00089999 ↗Enrolled (actual)
138
Serious AEs
23.9%
Results posted
Aug 2014
Primary outcomePrimary: Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Independent Review Committee (IRC) — 0; 0; 15; 18 Participants — p=0.691
Summary
This phase II study will evaluate and compare the efficacy and tolerability of two dose schedules (1500 mg QD and 500 mg BID) of oral Lapatinib as treatment for patients with advanced or metastatic breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Independent Review Committee (IRC) |
0; 0; 15; 18 | 0.691 |
| PRIMARY Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Investigator |
1; 2; 16; 20 | 0.443 |
| SECONDARY Percentage of Participants With Clinical Benefit (CR or PR or Stable Disease [SD] for at Least 24 Weeks), as Assessed by the IRC and Investigator |
29.0; 33.3; 29.0; 40.6 | — |
| SECONDARY Time to Response, as Assessed by the IRC and Investigator |
7.9; 7.9; 8.0; 8.0 | — |
| SECONDARY Duration of Response (DoR), as Assessed by the IRC and Investigator |
27.6; 29.0; 27.6; 29.0 | — |
| SECONDARY Progression-free Survival, as Assessed by the IRC and Investigator |
19.6; 24.4; 17.6; 20.3 | — |
| SECONDARY Time to Treatment Failure, as Assessed by IRC and Investigator |
15.7; 17.0; 12.3; 16.1 | — |
| SECONDARY Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) |
65; 61; 15; 18 | — |
Eligibility Criteria
Inclusion criteria
- Histologically confirmed invasive breast cancer with incurable stage IIIB, IIIC with T4 lesion or stage IV disease at primary diagnosis or at relapse after curative intent surgery.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Documented amplification of ErbB2 by Fluorescence in situ hybridization (FISH)
- Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST)
- Adequate renal, hepatic and cardiac function
Exclusion criteria
- Prior chemotherapy, immunotherapy, biologic therapy or anti-ErbB1/ErbB2 therapy other than adjuvant therapy. [Prior neo-adjuvant or adjuvant therapy (including trastuzumab) will be allowed provided it was stopped at least 12 months before study entry.
- Patients with active brain metastases
- Patients with bilateral breast cancer, bone metastases as the only disease site or metastases to more than 30% of the hepatic parenchyma.
Data sourced from ClinicalTrials.gov (NCT00089999). 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.