Nab-paclitaxel in Metastatic Breast Cancer Patients Failing Solvent Based Taxane (Tiffany) (NCT01416558) | Clinical Trial Compass
TerminatedPhase 2
Nab-paclitaxel in Metastatic Breast Cancer Patients Failing Solvent Based Taxane (Tiffany)
Stopped: Study was terminated because of extrem low recruitment
Germany66 participantsStarted 2011-07
Plain-language summary
Nab-paclitaxel has demonstrated to be an active agent in breast cancer and probably a less toxic alternative to solvent based taxanes. It is indicated in metastatic breast cancer after failure of anthracyclines. However, most patients receive anthracyclines as well as taxanes as part of their (neo-)adjuvant therapy. There is currently no standard treatment for patients with an early relapse (\<12 months) after a taxane containing (neo-)adjuvant therapy. Nab-paclitaxel, a novel nano-particle encapsulated paclitaxel is expected to have only limited cross-resistant to solvent-based taxanes and might therefore be indicated in this setting.
Who can participate
Age range
18 Years
Sex
FEMALE
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:
* Written informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures.
* Complete baseline documentation must be submitted via the web-based data collection system MedCODES to the GBG Forschungs GmbH.
* Diagnosis of locally advanced or metastatic hormone-sensitive or insensitive, HER2-negative or -positive breast cancer.
* Relapse within ≤ 12 months after completing (last day of last cycle) (neo-) adjuvant chemotherapy.
* Documented relapse of either a measurable or a non-measurable lesion according to the modified RECIST criteria.
* Previous neoadjuvant or adjuvant treatment with a solvent based taxane (paclitaxel or docetaxel) irrespective of dose and duration.
* Prior endocrine treatment for metastatic / advanced disease is allowed.
* Complete radiological and clinical tumor assessment within 4 weeks prior to registration performed as clinically indicated.
* Age ≥ 18 years.
* ECOG Performance Status ≤ 2 (irrespective of restrictions due to breast cancer).
* Laboratory requirements:Absolute neutrophil count (ANC) \>= 1.5 x 109/L., Platelets \>= 100 x 109/L., Hemoglobin \>= 9 g/dL (\>= 5.6 mmol/L)., Prothrombin time (PT) or international normalized ratio (INR) \<= 1.2x ULN (upper normal limit), Partial thromboplastin time (PTT) \<= 1.2x ULN, Total bilirubin \< 1.5x ULN, ASAT (SGOT) and ALAT (SGPT) \<= 2.5x ULN (concomitant elevations in serum bilirubin and ASAT/ALAT above 1.0x ULN a…
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.