Nab-Paclitaxel in Treating Older Patients With Locally Advanced or Metastatic Breast Cancer (NCT01463072) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Nab-Paclitaxel in Treating Older Patients With Locally Advanced or Metastatic Breast Cancer
United States40 participantsStarted 2012-06-19
Plain-language summary
This phase II trial studies the side effects of nab-paclitaxel in treating older patients with breast cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or to other places in the body (metastatic). Drugs used in chemotherapy, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Who can participate
Age range
65 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:
* Locally advanced or metastatic breast cancer
* Any estrogen receptor (ER), progesterone receptor (PR), or human epidermal growth factor receptor 2 (Her2neu) status as long as the patient will receive nab-paclitaxel alone
* First or second line chemotherapy treatment for metastatic disease
* Karnofsky performance status (KPS) \>= 70%
* Resolution of grade \>= 2 toxicity from prior therapy (other than alopecia)
* Peripheral neuropathy =\< grade 1
* Absolute neutrophil count \>= 1,500/mm\^3
* Platelets \>= 100,000 cells/mm\^3
* Hemoglobin (Hb) \>= 9.0 g/dl
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x institutional upper limit of normal
* Alkaline phosphatase =\< 2.5 x upper limit of normal unless bone metastasis are present in the absence of liver metastases
* Bilirubin =\< 1.5 mg/dl
* Creatinine clearance (calculated or 24 hour) \>= 30 ml/min
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Patients may not be receiving any other investigational agents
* Untreated central nervous system (CNS) metastases or symptomatic CNS metastases requiring escalating doses of corticosteroids
* Known history of allergic reactions to paclitaxel
* Presence of any serious or uncontrolled infection
* Receipt of a taxane for adjuvant therapy or metastatic disease in the last 12 months
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
Percent of Participants With Grade 2-5 Toxicity Using National Cancer Institute Common Toxicity Criteria Version 4.0
Timeframe: During and after treatment, up to 2.5 years
2
Percent of Participants With Grade 3 or Higher Toxicities Attributable to Treatment
Timeframe: On treatment, 28 days per cycle up to 30 months