ARV-471 for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast CancerARV-471 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new drug, ARV-471, to see if it is safe and effective at treating advanced breast cancer. The trial will also test if the new drug is more effective when used in combination with another drug, palbociclib.

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

6 Primary · 13 Secondary · Reporting Duration: through study completion, up to approximately 2 years

28 Days
Part A: Incidence of Dose Limiting Toxicities of ARV-471
Part C: Incidence of Dose Limiting Toxicities of combination ARV-471 + palbociclib
Week 4
Part A: Assessment of pharmacokinetic parameter area under the concentration-time curve (AUC).
Part A: Assessment of pharmacokinetic parameter maximum concentration (Cmax).
Part A: Assessment of pharmacokinetic parameter minimum concentration (Cmin).
Part A: Assessment of pharmacokinetic parameter time to maximum concentration (Tmax).
Week 4
Part C: Assessment of pharmacokinetic parameter maximum concentration (Cmax).
Part C: Assessment of pharmacokinetic parameter minimum concentration (Cmin).
Part C: Assessment of pharmacokinetic parameter time to maximum concentration (Tmax)
Part C:Assessment of pharmacokinetic parameter area under the concentration-time curve (AUC)
Week 4
Part B: Evaluation of Plasma Concentrations of ARV-471
First study drug dose through a minimum of 30 calendar Days After Last study drug administration
Part A: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-471
Part A: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-471
Part B: Evaluation of Safety and Tolerability
Part C: Incidence of laboratory abnormalities as a measure of safety and tolerability of combination ARV-471 + palbociclib
Part C: Number of Patients with Adverse Events as a measure of safety and tolerability of combination ARV-471 + palbociclib
Year 2
Part A: Assessment of anti-tumor activity of ARV-471
Part B: Assessment of anti-tumor activity of ARV-471
Part C: Assessment of anti-tumor activity of ARV-471 in combination with palbociclib

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

ARV-471 and palbociclib (IBRANCE®)
1 of 2
ARV-471
1 of 2

Experimental Treatment

215 Total Participants · 2 Treatment Groups

Primary Treatment: ARV-471 · No Placebo Group · Phase 1 & 2

ARV-471 and palbociclib (IBRANCE®)
Drug
Experimental Group · 1 Intervention: ARV-471 in combination with palbociclib (IBRANCE®) · Intervention Types: Drug
ARV-471
Drug
Experimental Group · 1 Intervention: ARV-471 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, up to approximately 2 years

Who is running the clinical trial?

Arvinas Inc.Lead Sponsor
2 Previous Clinical Trials
400 Total Patients Enrolled
1 Trials studying Breast Cancer
150 Patients Enrolled for Breast Cancer
Arvinas Estrogen Receptor, Inc.Lead Sponsor
8 Previous Clinical Trials
716 Total Patients Enrolled
3 Trials studying Breast Cancer
102 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,308 Previous Clinical Trials
7,110,620 Total Patients Enrolled
97 Trials studying Breast Cancer
26,867 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
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.
You have received at least 1 prior endocrine regimen for a minimum of 6 months in the locally advanced or metastatic setting.
Patients must have received up to 1 prior regimen of cytotoxic chemotherapy in the locally advanced or metastatic setting.
Patients must have received no more than two prior chemotherapy regimens for advanced disease.