Romidepsin and Abraxane in Treating Patients With Metastatic Inflammatory Breast Cancer (NCT01938833) | Clinical Trial Compass
TerminatedPhase 1/2
Romidepsin and Abraxane in Treating Patients With Metastatic Inflammatory Breast Cancer
Stopped: Closed by Sponsor
United States9 participantsStarted 2014-04
Plain-language summary
This phase I/II trial studies the side effects and best dose of romidepsin when given together with paclitaxel albumin-stabilized nanoparticle formulation and to see how well they work in treating patients with metastatic inflammatory breast cancer. Romidepsin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving romidepsin and paclitaxel albumin-stabilized nanoparticle formulation may be an effective treatment for inflammatory breast cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients must have histologically or cytologically confirmed breast carcinoma with a clinical diagnosis of IBC based on the presence of inflammatory changes in the involved breast, such as diffuse erythema and edema (peau d'orange), with or without an underlying palpable mass involving the majority of the skin of the breast. Pathological evidence of dermal lymphatic invasion should be noted but is not required for diagnosis.
. Patients may have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with RECIST criteria v. 1.1 as described in detail in section 11.0 or non-measurable tumors
. Patients must have demonstrated metastatic disease and not received \>2 lines of systemic therapy for metastatic disease
. Age \> 18 years
. ECOG performance status 0, 1 or 2
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum-Tolerated Dose of Romidepsin (Phase I)
Timeframe: 28 days
2
Progression-Free Survival (PFS)
Timeframe: The duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years
Trial details
NCT IDNCT01938833
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
. Patients must have normal organ and marrow function as defined below: a) Leukocytes \> 2,500/mcL b) Absolute neutrophil count \> 1,500/mcL c) Hemoglobin \> 9 g/dl d) Platelets \> 100,000/mcL e) Total bilirubin \< 1.5 mg/dl f) AST/ALT (SGOT/SGPT) \< 2.5 x ULN g) Alkaline Phosphatase \< 2.5 x ULN (unless bone metastasis is present in the absence of liver metastasis, in which case 3.0 x ULN would be acceptable. h) Serum magnesium \> 1.8 mg/dL i) Serum creatinine \< 1.5 mg/dl j) Serum potassium \> 3.8 mmol/L
. Tumor negative for HER2 expression (0 or 1+ by IHC) or negative FISH testing
. Patients must have a life expectancy of at least 12 weeks
Exclusion criteria
. Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse event from agents administered more than 4 weeks earlier
. Patients may not be receiving any other investigational agents or active anti-neoplastic therapies
. Patients who have previously received romidepsin or Abraxane
. Patients with untreated or uncontrolled brain metastases or leptomeningeal disease
. Patients with known hypersensitivity to any of the components of romidepsin or who have had hypersensitivity reactions to paclitaxel
. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements