Lapatinib Ditosylate and Capecitabine in Treating Patients With Stage IV Breast Cancer and Brain … (NCT00967031) | Clinical Trial Compass
CompletedPhase 2
Lapatinib Ditosylate and Capecitabine in Treating Patients With Stage IV Breast Cancer and Brain Metastases
France45 participantsStarted 2009-04
Plain-language summary
RATIONALE: Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lapatinib ditosylate together with capecitabine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving lapatinib ditosylate together with capecitabine works in treating patients with stage IV breast cancer and brain metastases.
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.
DISEASE CHARACTERISTICS:
* Histologically confirmed invasive breast cancer
* Stage IV disease
* At least 1 measurable CNS lesion ≥ 10 mm on T1-weighted gadolinium-enhanced MRI
* No single brain metastasis that could be treated by surgery
* HER-2 positive primary tumor as defined as IHC3+ or IHC2+ and FISH-positive
* Hormone receptor status: not specified
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Life expectancy ≥ 3 months
* Absolute Neutrophil Count (ANC) ≥ 1,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 10g/dL
* Creatinine ≥ 1.5 times upper limit of normal (ULN)
* Albumin ≥ 2.5 g/dL
* Serum bilirubin ≤ 1.5 times ULN (unless due to Gilbert's syndrome)
* ASAT and ALAT ≤ 3 times ULN (≤ 5 times ULN with documented liver metastasis)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception 2 weeks before, during, and for 28 days after completion of study treatment (female) or for 1 week after completion of treatment (male)
* Able to swallow and retain oral medication
* Affiliated to a Social Security System
* No known contraindication to MRI
* No prior or active malignancy, unless disease free for ≥ 10 years
* No other concurrent severe and/or uncontrolled medical disease which could compromise study participation, including any of the following:
* Infection
* Cardiac disease (e.g., uncontrolled hypertension, congestive card…
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.