Expired Study
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New York, New York 10016


Purpose:

This study will investigate the effectiveness of combination of carboplatin and investigational agent RAD001 in triple-negative breast cancer.


Study summary:

This study is an open label phase II trial of carboplatin and RAD001 in women with triple-negative breast cancer. Carboplatin will be given as an IV infusion every three weeks. RAD001 will be given as a 5 mg pill daily with a run in of 3 patients. If there is a dose limiting toxicity (any toxicity requiring dose modification or interruption) among the first 3 patients, that number will be increased to 6 patients. If the 5 mg dose is found to be tolerable among the first 3 patients, the RAD001 dose will be increased to a 10 mg pill daily. In the unexpected case of 2 or more DLT's at 5 mg/day or 1 or more DLT's in the additional 3 patients, further dosing will be reviewed by the PI in conjunction with the NYU DSMC. Patients will be assessed for response every two cycles with either PET/CT or CT of the chest, abdomen, and pelvis and a bone scan. In addition patients will be followed with serial CEA and CA 27-29 levels. The patients will continue on the protocol until there is progression of disease or unacceptable toxicity.


Criteria:

Inclusion Criteria: - Women with metastatic breast cancer (measurable or evaluable including bone metastases only) - Histologically confirmed triple negative breast cancer (ER< 10%, PR < 10 %, Her2neu IHC 0 or 1 OR FISH negative) - Age >= 18 years - WHO performance status <= 2 - Adequate bone marrow function as shown by: ANC ≥ 1.5 x 10E9/L, Platelets ≥ 100 x 10E9/L, Hb >9 g/dL - Adequate liver function as shown by: 1. serum bilirubin ≤ 1.5 x ULN 2. INR: Patients not on warfarin INR ≤1.5; Patients on warfarin INR ≤3; Patient on stable dose of LMW heparin for >2 weeks at time of treatment is allowed. 3. ALT and AST ≤ 2.5x ULN (≤ 5x ULN in patients with liver metastases) - Adequate renal function: serum creatinine ≤ 1.5 x ULN - Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication. - Signed informed consent - Patients may have had 0-3 prior regimens for metastatic disease and prior bevacizumab (avastin) is allowed. - A baseline lung CT (or PET/CT) - O2 sat >= 90% in room air (if <90%, spirometry and DLCO above 50% of the normal predicted value of PFT) - Negative serum pregnancy test within 7 days prior to starting treatment Exclusion Criteria: - Patients currently receiving anticancer therapies or who have received anticancer therapies within 2 weeks of the start of study drug (including chemotherapy, radiation therapy, and biologics) - Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study - Prior treatment with any investigational drug within the preceding 2 weeks - Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent, except corticosteroids with a daily dosage equivalent to prednisone ≤ 20 mg. However, patients receiving corticosteroids must have been on a stable dosage regimen for a minimum of 4 weeks prior to the first treatment with RAD001. Topical or inhaled corticosteroids are allowed. - Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period - Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases - Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin. - Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: - Symptomatic congestive heart failure of New York heart Association Class III or IV - unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease - severely impaired lung function as defined as spirometry and DLCO that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air - uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN - active (acute or chronic) or uncontrolled severe infections - liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all patients. HBV DNA and HCV RNA PCR testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection. See Appendix I (Hep Screening Form) - A known history of HIV seropositivity - Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (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 RAD001) - Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus). - Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients - History of noncompliance to medical regimens - Patients unwilling to or unable to comply with the protocol - Ongoing alcohol or drug addiction


NCT ID:

NCT01127763


Primary Contact:

Principal Investigator
Amy Tiersten, MD
New York University School of Medicine


Backup Contact:

N/A


Location Contact:

New York, New York 10016
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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