Phase 2
N=58
Phase II Trial of EVEROLIMUS ± Trastuzumab in Hormone-Refractory Metastatic Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00912340 ↗Enrolled (actual)
58
Serious AEs
12.1%
Results posted
Dec 2018
Primary outcome: Primary: Progression-free Survival (PFS) Until First Progression — 2.0; 5.7 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Everolimus (Drug); Trastuzumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) Until First Progression |
2.0; 5.7 | — |
| SECONDARY Progression-free Survival (PFS) in Patients Who Crossed Over |
6.3; 3.1 | — |
Summary
This phase II trial studies how well everolimus with or without trastuzumab works in treating patients with breast cancer that has not responded to hormone therapy and has spread from where it started to other places in the body. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells to grow and spread. Giving everolimus and adding trastuzumab at the time of disease progression may be an effective treatment for breast cancer.
Eligibility Criteria
Inclusion Criteria
Patients will be included in the study based on the following criteria:
- Hormone-refractory metastatic breast cancer defined as disease progression within 6 months from starting most recent hormonal therapy
- At least one line of endocrine therapy in the metastatic setting
- Candidate for hormonal therapy (ER and/or progestin receptor [PR]-positive at primary diagnosis and at metastatic diagnosis where tissue is available)
- HER2/neu-negative breast cancer by standard criteria (immunohistochemistry [IHC] 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Adequate bone marrow function as indicated by the following:
- Absolute neutrophil count (ANC) > 1500/µL
- Platelets ≥ 100,000/µL
- Hemoglobin > 10 g/dL
- Adequate renal function, as indicated by creatinine ≤ 1.5x upper limit of normal (ULN)
- Adequate liver function, as indicated by bilirubin ≤ 1.5x ULN
- International normalized ratio (INR) ≤ 1.3 (or ≤ 3 on anticoagulants)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 1.5 x ULN
- Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
- A known history of HIV seropositivity
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
- Patients with an active, bleeding diathesis
- Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Hormonal contraceptives are not acceptable as a sole method of contraception. (Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of everolimus)
- Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus)
- Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs, resulting in dyspnea at rest
- Taking any of the following agents:
- Chronic treatment with systemic steroids or another immunosuppressive agent
- Live vaccines
- Drugs or substances known to be inhibitors or inducers of the isoenzyme cytochrome P450, family 3, subfamily A (CYP3A)
Data sourced from ClinicalTrials.gov (NCT00912340). 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.