Pertuzumab, Trastuzumab, and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating P… (NCT01730833) | Clinical Trial Compass
CompletedPhase 2
Pertuzumab, Trastuzumab, and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With HER2-Positive Advanced Breast Cancer
United States63 participantsStarted 2013-07-17
Plain-language summary
This phase II trial studies how well pertuzumab, trastuzumab, and paclitaxel albumin-stabilized nanoparticle formulation work in treating patients with human epidermal growth factor receptor (HER) 2-positive stage II-IV breast cancer. Monoclonal antibodies, such as pertuzumab and trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to kill tumor cells or stop them from growing. Giving pertuzumab and trastuzumab together with paclitaxel albumin-stabilized nanoparticle formulation may be a better way to block tumor growth.
Who can participate
Age range
19 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 be diagnosed with metastatic cytologically or histologically confirmed adenocarcinoma of the breast with HER2 over-expression or with newly diagnosed locally advanced (including inflammatory) breast cancer (LABC) with stage II-III disease; patients with metastatic (stage IV) disease (MBC) must have measurable lesions
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
* Tumor positive or negative for expression of hormone receptors (\< 1% or \> 1%) and overexpressing HER2 by immunohistochemistry (IHC) (3+), or, HER2-amplified by fluorescence in situ hybridization (FISH) or by alternative gene testing
* For patients with LABC, no prior therapy is allowed
* For patients with MBC, prior adjuvant chemotherapy and trastuzumab more than or equal to 12 months prior to enrollment are allowed
* No prior chemotherapy or trastuzumab for treatment of metastatic breast cancer
* Left ventricular ejection fraction (LVEF) \>= 50% (determined by echocardiogram or multigated acquisition scan) within 42 days of treatment
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Hemoglobin \>= 9 g/dl
* Leukocytes \>= 3.0 x 10\^9/L…
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.
1Since this Phase 2 trial has already completed, has the data been published, and what did the results show about how long patients went without their cancer progressing when treated with pertuzumab, trastuzumab, and nab-paclitaxel together?
2This trial studied two different groups — people with metastatic breast cancer and people with locally advanced breast cancer — and measured different outcomes for each, so which group would my situation most closely match, and what does that mean for how relevant the results are to me?
3Phase 2 trials are designed to test whether a treatment shows promise but typically involve smaller numbers of patients than Phase 3 trials, so how confident can we be in the safety and effectiveness signals from this study before considering this combination approach?
4Nab-paclitaxel combined with two HER2-targeted therapies like pertuzumab and trastuzumab is a demanding regimen — what side effects were seen in this trial, and how might that treatment burden fit with my current health and day-to-day life?
5Are there now completed Phase 3 trials or standard-of-care options that built on what this study found, and would those be a better starting point for my treatment plan before considering this combination?
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.