Phase 2
N=38
Erlotinib Hydrochloride and Bevacizumab in Treating Patients With Stage IV Breast Cancer
Recurrent Breast Carcinoma · Stage IV Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00054132 ↗Enrolled (actual)
38
Serious AEs
15.8%
Results posted
Jul 2017
Primary outcome: Primary: Level of EGFR Expression — 24; 8; 4; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bevacizumab (Biological); Erlotinib Hydrochloride (Drug); Laboratory Biomarker Analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Level of EGFR Expression |
24; 8; 4; 0; 2 | — |
| PRIMARY Response Rate, Defined as Complete Response (CR) + Partial Response (PR), Using the Response Evaluation Criteria in Solid Tumors |
0; 1; 17; 19 | — |
| SECONDARY Duration of Response |
52 | — |
| SECONDARY Time to Progression |
11 | — |
| SECONDARY Number of Patients Evaluated for Toxicity |
38 | — |
| SECONDARY Participants With Duration of Stable Disease Greater Than or Equal to 6 Months |
— | — |
Summary
This phase II trial studies how well erlotinib hydrochloride and bevacizumab work in treating patients with stage IV breast cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Giving erlotinib hydrochloride and bevacizumab may be an effective treatment for breast cancer.
Eligibility Criteria
Inclusion Criteria
- Patients must have histologically or cytologically confirmed carcinoma of the breast with metastatic (stage IV) disease that is currently stable or progressing after therapy
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan
- Patients must have either stable disease or disease progression on or after therapy with one or two conventional chemotherapy regimens for the treatment of metastatic (stage IV) breast cancer
- Prior treatment with high-dose chemotherapy and autologous stem cell/bone marrow transplantation is allowed, and is considered one prior regimen when administered for metastatic disease
- There is no restriction for the number of prior hormonal therapies or immunotherapies
- If human epidermal growth factor receptor 2 (Her2)/neu-positive (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescence in situ hybridization [FISH]), prior therapy with trastuzumab required
- Any number of prior regimens of chemotherapy and/or hormonal therapy are allowed in the adjuvant setting, and do not count towards prior therapy when determining eligibility for this trial
- Eastern Cooperative Oncology Group (ECOG) performance status = = 60%)
- Life expectancy of greater than 3 months
- Leukocytes >= 3,000/ul
- Absolute neutrophil count >= 1,000/ul
- Platelets >= 75,000/ul
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT[) = = 60 mL/min for patients with creatinine levels outside institutional normal using the Cockcroft-Gault formula
- Women of childbearing potential must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Patients must have breast cancer tissue available as either paraffin blocks or unstained slides for planned correlative science sub study
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
- Patients who have had chemotherapy, radiotherapy immunotherapy or investigational therapy within 3 weeks prior to starting treatment (6 weeks for nitrosoureas or mitomycin C), or hormonal therapy within 2 weeks prior to starting treatment
- Patients may not be receiving any other investigational agents
- History or evidence upon physical examination of central nervous system (CNS) disease (e.g., primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of stroke); all subjects must have a baseline CT or magnetic resonance imaging (MRI) of the head
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to OSI-774 or bevacizumab
- Prior treatment with kinase insert domain receptor (KDR) inhibitors (e.g. vascular endothelial growth factor [VEGF] Trap, Su5416, Su6668, ZD6474, PTK757, IMC-1CII)
- Prior treatment with EGFR targeting therapies (e.g. ZD1839 or C225)
- Major surgery, open biopsy or significant traumatic injury occurring within 28 days prior to treatment; this does not apply to indwelling catheters, which require an interval of at least 24 hours between placement of the catheter and treatment with bevacizumab
- Current or recent (within 10 days prior to treatment) use of full-dose oral or parenteral anticoagulants or thrombolytic agents (except as required to maintain patency of preexisting, permanent indwelling IV catheters; for subjects receiving warfarin, international normalized ratio [INR] should be 325 mg/day) or nonsteroidal anti
Data sourced from ClinicalTrials.gov (NCT00054132). 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.