Breast Cancer Clinical Trial
A Phase I/II Clinical Trial of Vidaza With Abraxane in Patients With Advanced/Metastatic Solid Tumors and Breast Cancer
Summary
The purpose of this clinical trial is to test whether treatment of patients with advanced or metastatic solid tumors or breast cancer with Abraxane plus Vidaza is safe and results in good tumor response. All patients enrolling in this study will receive treatment with Abraxane and Vidaza. Safety will be assessed by adverse events, laboratory results and performance status. Tumor response will be measured by RECIST criteria.
Full Description
The phase I part of the study will enroll patients with advanced or metastatic solid tumors who have failed at least one previous treatment. The purpose of the phase I part is to assess the safety of the investigational treatment and select the recommended phase II dose-regimen. The phase II part of the study will enroll patients with advanced or metastatic HER2-negative breast cancer who have not received treatment for their metastatic disease. The purpose of the phase II part of the study is to assess safety and efficacy of the investigational treatment in breast cancer. The study doctor will determine what phase patients will be enrolled in.
Eligibility Criteria
Inclusion Criteria:
For phase I, any solid tumors, including lymphoma, that progressed or were stable as best response on at least one previous therapy and are evaluable.
For phase II, pathologically confirmed breast cancer, measurable disease, no prior treatments for recurrent or metastatic breast cancer.
Her-2/neu negative (Phase II)
Negative pregnancy test for female subjects
Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with azacitidine or nab-paclitaxel. investigator.
Male or female for phase I and female for phase II, >19 years of age and any race.
Exclusion Criteria:
Major surgery, radiotherapy, chemotherapy or investigational agents within 4 weeks of treatment day 1
Known brain metastases
Prior taxanes (except for adjuvant therapy more than 6 months prior to treatment day 1) (phase II)
Active infection requiring antibiotic therapy
History of allergy or hypersensitivity to nab-paclitaxel, albumin or a taxane
Grade 2 or greater motor or sensory neuropathy
Prior cytotoxic chemotherapy for recurrent or metastatic breast cancer (phase II portion)
Uncontrolled hypertension, arrhythmia, congestive heart failure or angina. Patients who have had a myocardial infarction or cardiac surgery should be at least 6 months from the event and free of active symptoms.
Known or suspected hypersensitivity to azacitidine or mannitol
Pregnant or breast feeding
Patients with advanced malignant hepatic tumors
Malignancy other than breast carcinoma (phase II)
Known HIV infection or chronic hepatitis B or C
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Salt Lake City Utah, 84112, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.