Trial of Anastrozole and Palbociclib in Metastatic HER2-Negative Breast Cancer (NCT02942355) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Trial of Anastrozole and Palbociclib in Metastatic HER2-Negative Breast Cancer
United States40 participantsStarted 2016-12-07
Plain-language summary
This is an open-label, pilot study designed to evaluate the safety and feasibility of combining anastrozole and palbociclib in the following two cohorts: Cohort A) as first-line therapy and Cohort B) as maintenance therapy after first-line chemotherapy in postmenopausal patients with HR-positive, HER2-negative metastatic breast cancer. Pre- and perimenopausal women must receive therapy with an LHRH agonist. The LHRH agonist will be by choice for an approved LHRH agonist administered according to its respective prescribing information. Following informed consent and eligibility check, subjects will be enrolled to either Cohort A or Cohort B.
Who can participate
Age range
18 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:
* Are 18 years of age or older, who are either:
* Postmenopausal, as defined by at least one of the following criteria:
* Age greater than or equal to 60 years;
* Age less than 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and serum estradiol, FSH and LH level within the laboratory reference range for postmenopausal females;
* Documented bilateral oophorectomy;
* Medically confirmed ovarian failure OR premenopausal or perimenopausal, i.e., not meeting the criteria for being postmenopausal.
* Premenopausal or perimenopausal women can be enrolled if amenable to be treated with an LHRH agonist. Patients must have commenced treatment with an LHRH agonist at least 4 weeks prior to start of study treatment.
* Histologically or cytological confirmed diagnosis of breast cancer with evidence of metastatic disease. Locally advanced disease not amenable to resection is eligible.
* Documentation of ER-positive and, or PR-positive tumor based on most recent tumor biopsy (unless bone-only disease). ER and PR assays are considered positive if there is at least 1 percent positive in the tumor sample.
* Documentation of HER2-negative tumor based on most recent tumor biopsy. Tumor must not demonstrate overexpression of HER2 by either IHC (immunohistochemistry) or in-situ hybridization (ISH).
* No previous treatment for metastatic disease for Cohort A.
* For Cohort A: previous …
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.
1This trial is specifically measuring how many people had to permanently stop treatment because of neutropenia — a dangerous drop in white blood cells — so how would my own blood counts and immune health affect whether this combination of anastrozole and palbociclib might be safe for me to consider?
2Since this is a Phase 2 trial, the researchers are still building safety and effectiveness data — what do we know so far about how this combination compares to other standard treatment options for HER2-negative metastatic breast cancer?
3The trial is no longer enrolling new participants, so is there any way I could still access palbociclib combined with an aromatase inhibitor like anastrozole through an approved treatment plan or a different study?
4If neutropenia is the main safety concern being tracked in this trial, what signs or symptoms should I watch for, and how is that risk typically managed if it does occur?
5Given that this targets HER2-negative metastatic breast cancer specifically, would you be able to look at my pathology results and tell me whether my cancer's receptor profile would even make this type of combination therapy worth exploring?
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
Number of participants with neutropenia that leads to permanent treatment discontinuation
Timeframe: From enrollment to treatment discontinuation; participants remain on treatment until disease progression, unacceptable toxicity, participant withdrawal, or investigator decision. Assessed for approximately 4 years.