A Phase 1/2 Trial of ARV-471 Alone and in Combination With Palbociclib (IBRANCE®) in Patients Wit… (NCT04072952) | Clinical Trial Compass
CompletedPhase 1/2
A Phase 1/2 Trial of ARV-471 Alone and in Combination With Palbociclib (IBRANCE®) in Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer
United States217 participantsStarted 2019-08-05
Plain-language summary
This is a Phase 1/2 dose escalation and cohort expansion study and will assess the safety, tolerability and anti-tumor activity of ARV-471 alone and in combination with palbociclib (IBRANCE®) in patients with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer, who have received prior hormonal therapy and chemotherapy in the locally advanced/metastatic setting.
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:
Part A, Part B, and Part C:
* Patients at least 18 years of age at the time of signing the informed consent.
* Patients must have histologically or cytologically confirmed ER+ and HER2- advanced breast cancer for which standard curative therapy is no longer effective or does not exist.
* Patients must have measurable or non-measurable disease by RECIST criteria (version1.1), with radiologic tumor assessments performed within 28 days of the first dose of therapy.
* Patients must be willing to undergo a core biopsy of accessible tumor within 4 weeks prior to the initiation of study treatment and a follow-up biopsy on treatment for ER immunohistochemistry (IHC) testing and pharmacodynamics (PD) studies. (Patients without accessible tumor tissue may be eligible after discussion with the Medical Monitor.)
* Women must be postmenopausal due to surgical or natural menopause.
Part A:
\- Patients must have received at least 2 prior endocrine regimens in any setting (neoadjuvant, adjuvant or advanced/metastatic) a CDK4/6 inhibitor and up to 3 prior regimens of cytotoxic chemotherapy in the locally advanced or metastatic setting.
Part B:
* Patients must have received at least 1 prior endocrine regimen for a minimum of 6 months in the locally advanced or metastatic setting; if more than 1 prior endocrine regimen has been administered, only one of the regimens must have been administered for a minimum of 6 months in the locally advanced or metastatic setting
* Pa…
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 has already completed — do you know what the safety and side effect data showed for ARV-471 alone and in combination with palbociclib, and how does that compare to my current treatment options?
2Since this was a Phase 1/2 trial focused heavily on finding safe doses and measuring adverse events, how much is actually known so far about whether ARV-471 shrank tumors or slowed disease progression in people with ER-positive, HER2-negative metastatic breast cancer like mine?
3The trial tested ARV-471 both on its own and combined with palbociclib, which I understand is already an approved drug — given what the results showed, is there a follow-up trial or a more advanced study I might be eligible for that builds on this research?
4Before considering any experimental option like ARV-471, are there standard ER+/HER2- metastatic breast cancer treatments — like existing CDK4/6 inhibitors or hormonal therapies — that I should try first, and how would those stack up against what this trial found?
5Since the trial measured laboratory abnormalities as a key safety signal, are there any specific blood or organ function issues I should be monitored for if a drug like ARV-471 ever becomes available outside of a trial setting?
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
Part A: Incidence of Dose Limiting Toxicities of ARV-471
Timeframe: 28 Days
2
Part A: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-471
Timeframe: First study drug dose through a minimum of 30 calendar Days After Last study drug administration
3
Part A: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-471
Timeframe: First study drug dose through a minimum of 30 calendar Days After Last study drug administration
4
Part B: Assessment of anti-tumor activity of ARV-471
Timeframe: through study completion, up to approximately 2 years
5
Part C: Incidence of Dose Limiting Toxicities of combination ARV-471 + palbociclib
Timeframe: 28 Days
6
Part C: Number of Patients with Adverse Events as a measure of safety and tolerability of combination ARV-471 + palbociclib
Timeframe: First study drug dose through a minimum of 30 calendar Days After Last study drug administration