Phase 2
N=27
Trastuzumab and Erlotinib as First-Line Therapy in Treating Women With Metastatic Breast Cancer Associated With HER2/Neu Overexpression
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00033514 ↗Enrolled (actual)
27
Serious AEs
59.3%
Results posted
Apr 2016
Primary outcome: Primary: The Objective Response Rate as Defined as Stable Disease or the Rate of Complete and Partial Responses Determined on Two Consecutive Occasions Greater Than or Equal to 4 Weeks Apart. — 4; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- trastuzumab (Biological); erlotinib hydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Jonsson Comprehensive Cancer Center
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Objective Response Rate as Defined as Stable Disease or the Rate of Complete and Partial Responses Determined on Two Consecutive Occasions Greater Than or Equal to 4 Weeks Apart. |
4; 1 | — |
| PRIMARY Recommended Dose for Phase II |
6; 3; 5 | — |
| SECONDARY Duration of Objective Response |
4; 2 | — |
| SECONDARY Incidence of Adverse Events |
16 | — |
| SECONDARY Serum Concentration of Herceptin at Specified Time-points. |
98.4; 46; 86; 46.9; 88.3; 50.8 | — |
Summary
RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Combining trastuzumab with erlotinib may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with erlotinib as first-line therapy in treating women who have metastatic breast cancer associated with HER2/neu overexpression.
Eligibility Criteria
Inclusion Criteria
- Women aged > 18 years
- Histologically documents metastatic breast cancer
- HER2 positive using Fluorescence In Situ Hybridization (FISH)
- For phase I, patients who have previously received treatment for their metastatic disease are allowed to participate.
- For the phase II portion of the study, patients must have measureable disease (> 2 cm; > 1 cm on spiral CT scan)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- A life expectancy of > 3 months
- Use of effective means of contraception
Exclusion Criteria
- For Phase II, prior cytotoxic chemotherapy and/or prior Herceptin for their metastatic disease. Prior treatment in the adjuvant setting is allowed.
Data sourced from ClinicalTrials.gov (NCT00033514). 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.