Benefit of Adding Trastuzumab to Second Line Chemotherapy in Breast Cancer Patients Previously Tr… (NCT00130507) | Clinical Trial Compass
TerminatedPhase 2
Benefit of Adding Trastuzumab to Second Line Chemotherapy in Breast Cancer Patients Previously Treated With Trastuzumab
Stopped: A new alternative treatment caused the decrease in the rhythm of recruitment.
Spain14 participantsStarted 2005-11-04
Plain-language summary
Eligible patients must receive vinorelbine plus capecitabine, with or without trastuzumab, until disease progression or unbearable toxicity. Cycles will be administered every 3 weeks.Human epidermal growth factor receptor 2 (HER2) status must be locally assessed by immunohistochemistry (IHC). All 3+ patients are eligible. In 2+ patients, HER2 status must be confirmed by fluorescence in situ hybridization (FISH).
Who can participate
Age range
18 Years – 70 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.
* Women older than 18 years old.
* HER2 positive breast cancer with histological diagnoses.
* Non-operable locally advanced or metastatic disease, previously treated with trastuzumab and taxanes.
* Measurable or non-measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST).
* Disease progression during or after treatment with trastuzumab and taxanes.
* Maximum of 1 previous chemotherapy line for advanced or metastatic disease.
* Previous radiotherapy is allowed if radiated area is not the only documented lesion.
* At least 4 weeks since the last administration of antineoplastic treatment and all toxicities resolved.
* Performance status Eastern Cooperative Oncology Group (ECOG) \>=2.
* Life expectancy of at least 12 weeks.
* Left Ventricular Ejection Fraction (LVEF) evaluation (\>=50%) in previous 4 weeks.
* Hematology:
* neutrophils \>=1.5 x 10e9/l;
* platelets \>= 100 x 10e9/l;
* hemoglobin \>= 10 mg/dl
* Hepatic function:
* total bilirubin \<= 1.5 x under normal limit (UNL);
* Aspartate aminotransferase (SGOT) and Alanine aminotransferase (SGPT) and alkaline phosphatase \<= 2.5 x UNL, or \<=5 x UNL if hepatic lesions present
* Renal function:
* creatinine \<= 175 µmol/l (2 mg/dl);
* creatinine clearance \>= 60 ml/min.
* Patients able to comply with treatment and follow-up.
* Negative pregnancy test in the previous 14 days. Adequate contraceptive method during treatment and up to 3 month…
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
Clinical benefit rate
Timeframe: Through study completion, an average of 1 year