Patients With Brain Metastases From HER2-positive Breast Cancer (NCT02135159) | Clinical Trial Compass
CompletedPhase 1
Patients With Brain Metastases From HER2-positive Breast Cancer
France36 participantsStarted 2014-02
Plain-language summary
The purpose of this study is to determine the optimal sequences of combined trastuzumab emtansine (T-DM1) and whole-brain radiotherapy in patients presenting brain metastases from HER2-positive breast cancer in terms of acute toxicities and blood/cerebrospinal fluid T-DM1 pharmacokinetics.
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.
Inclusion criteria
. Histologically confirmed invasive breast cancer with stage IV disease.
. HER-2 positive primary tumor, defined as: IHC3+, or IHC2+ and ISH positive.
. Non operable brain metastases (n ≥ 2) with at least one measurable CNS lesion ≥ 10 mm on T1-weighted gadolinium-enhanced MRI.
. No stereotaxie radiotherapy indication
. At least two weeks from any specific breast cancer treatment (such as Trastuzumab, chemotherapy, immunotherapy/biological response modifiers, endocrine therapy and radiotherapy).
. Adequate hematologic function (ANC ≥1x109/L, platelets ≥100 000/L; Hb \>10g/dL), renal function (creatinine ≤ 1.5x UNL) and hepatic function (albumin ≥2.5 g/dL; serum bilirubin ≤1.5x ULN unless due to Gilbert's syndrome; AST and ALT ≤ 5x ULN if documented liver metastasis or ≤ 3x ULN without liver metastasis).
. At least 18 years old.
. ECOG Performance Status of 0 to 2.
Exclusion criteria
. Previous whole brain radiotherapy (WBRT) or brain stereotaxie radiotherapy.
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
optimal sequences of combined treatment
Timeframe: 3 months
Trial details
NCT IDNCT02135159
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle
. Planned or concurrent systemic treatment or radiation therapy (other than corticosteroid, bisphosphonates or mannitol).
. Known contra-indication to MRI.
. Active concurrent malignancy. If there is a history of prior malignancy, the patient must be disease free for at least 10 years.
. Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as :
. Pregnant women, women who are likely to become pregnant or are breast-feeding.
. Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
. Known hypersensibility to any component of T-DM1