CompletedPhase 2

Caelyx, Cyclophosphamide and Herceptin in Patients With Metastatic Breast Cancer

Spain49 participantsStarted 2006-02-15

Plain-language summary

Eligible patients must receive Caelyx plus Cyclophosphamide plus Herceptin for 6 cycles that will be administered every 4 weeks.

Who can participate

Age range

18 Years – 75 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: * Patients must sign an informed consent before of specific procedures of clinical trial. * Patients with histologically confirmed breast cancer and overexpression of Her2neu. * Age\> 18 years. * Eastern Cooperative Oncology Group (ECOG) equal or \< 2. * Patients have not been treated previously with chemotherapy for metastatic disease. * Patients must have at least one measurable lesion according to RECIST criteria. * Patients should have an adequate organ function to tolerate chemotherapy. Exclusion Criteria: * Patients with hypersensitivity reactions to any of the medications of the clinical trial. * Patients who are pregnant or lactating are not eligible. * Hepatic disease. * Not controlled active infection * Symptomatic metastatic brain cancer * Previous adjuvant treatment with anthracyclines with a total accumulated dose \> 300 mg/m2 (Doxorubicin) or \> 600 mg/m2 (Epirubicin)

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

Objective Response Rate (ORR)

Timeframe: Up to cycle 6 (24 weeks)

Trial details

NCT IDNCT00258960

SponsorSpanish Breast Cancer Research Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-07

Results submitted2019-01-25

View on ClinicalTrials.gov More Breast Cancer trials