Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HE… (NCT03633331) | Clinical Trial Compass
CompletedPhase 2
Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer
United States93 participantsStarted 2018-08-15
Plain-language summary
This phase II trial studies the side effects and how well palbociclib and letrozole or fulvestrant works in treating patients aged 70 years and older with estrogen receptor positive, HER2 negative breast cancer that has spread to other places in the body. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as letrozole or fulvestrant, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving palbociclib and letrozole or fulvestrant may work better in treating patients with breast cancer. The trial will explore factors other than chronologic age that can affect toxicity rates as identified using a cancer-specific geriatric assessment.
Who can participate
Age range
70 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:
* Documentation of disease: estrogen receptor positive and/or progesterone receptor (PR) positive, HER2 negative metastatic breast cancer; histologic confirmation is required
* Measurable disease or non-measurable disease
* Planning to begin palbociclib for metastatic disease; one prior line of endocrine therapy and/or chemotherapy for metastatic disease is allowed; patients may begin or have already begun endocrine therapy before they start palbociclib treatment, but no more than two weeks prior to registration
* No prior therapy with a CDK inhibitor
* Resolution of all acute toxic effects of prior therapy or surgical procedures to CTCAE grade =\< 1 (except alopecia) or to baseline toxicities prior to previous therapy or surgical procedures, prior to registration
* No untreated brain metastases; patients with treated brain metastases must have completed treatment with steroids to be eligible
* No known interstitial lung disease
* No second malignancies other than non-melanoma skin cancers or cervical carcinoma in situ; however, patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for \>= 3 years
* No active infection requiring treatment with antibiotics
* Patients must be able to swallow and retain oral medication
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
* Patients must be able to read and comprehend English or Spanish
* Absolute neutrophil count (ANC) \…
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 is a Phase 2 trial combining palbociclib with letrozole or fulvestrant for metastatic ER-positive, HER2-negative breast cancer, and it's already completed, has the safety data been published — and what kinds of adverse events were most commonly reported?
2Given that the primary outcome of this trial was tracking the incidence of adverse events rather than survival or tumor shrinkage, what does that tell us about how much is still unknown about the long-term benefit of this particular combination for my stage of breast cancer?
3How does this palbociclib combination compare to what would be considered standard treatment for my ER-positive, HER2-negative metastatic breast cancer right now, and would it make more sense to try standard options first?
4Since the trial is completed, is there any way I could access a treatment approach similar to what was studied here — either through a follow-up study, standard prescribing, or another open trial — and would you recommend that path for my situation?
5Given that this trial enrolled people with Stage IV breast cancer, what specific factors about my own health history and disease would help you decide whether a CDK4/6 inhibitor like palbociclib combined with hormone therapy is appropriate for me to discuss further?
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.