ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer (TACTIVE-E)

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Status and phase

Active, not recruiting
Phase 1


Breast Cancer


Drug: ARV-471 in combination with Everolimus

Study type


Funder types



C4891020 (Other Identifier)

Details and patient eligibility


A phase 1b study to assess the combination of ARV-471 and everolimus in participants with advanced or metastatic ER+/HER2- breast cancer.

Full description

This is a Phase 1b study to assess the safety and tolerability of ARV-471 in combination with everolimus in participants with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced or metastatic breast cancer, who have received a prior CDK4/6 inhibitor and endocrine therapy in the advanced/metastatic setting.


32 patients




18+ years old


No Healthy Volunteers

Inclusion criteria

  • Histologically or cytologically confirmed ER+ and HER2-advanced breast cancer (metastatic, recurrent, or unresectable)
  • Women must be postmenopausal, or pre-/peri-menopausal women must be on ovarian suppression
  • Measurable disease or non-measurable (evaluable) disease per RECIST v1.1
  • Received a minimum of 1 and up to 3 lines of anti-cancer therapy in the advanced/metastatic setting: must have received and progressed on (or were intolerant to) a CDK 4/6 inhibitor, either alone or in combination; must have received at least one endocrine therapy, either alone or in combination; may have received up to one line of chemotherapy
  • Must be willing to use dexamethasone mouthwash for the prevention of everolimus-induced stomatitis
  • ECOG performance status of 0 or 1

Exclusion criteria

  • Untreated brain metastases or brain metastases requiring steroids above physiologic replacement doses
  • Prior treatment with ARV-471
  • Prior treatment targeting mTOR (e.g. everolimus)
  • Prior anticancer or investigational drug treatment within 28 days (fulvestrant) or 14 days (tamoxifen or aromatase inhibitor, or CDK 4/6 inhibitor) before the first dose of study drug
  • Prior anticancer or investigational anticancer drug therapy within 28 days or 5 half-lives (whichever is shorter) before the first dose of study drug, except as mentioned above
  • Any of the following in the previous 12 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, or other clinically significant episode of thromboembolism
  • Any of the following in the previous 6 months: congenital long QT syndrome, Torsade de Pointes, sustained ventricular tachyarrhythmia and ventricular fibrillation, left anterior hemiblock, ongoing cardiac arrythmias/dysrhythmias, atrial fibrillation
  • Hypertension that cannot be controlled by medication (>150/90 mmHg despite optimal medical therapy)
  • Active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus, hepatitis C virus, known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness
  • Known history of drug-induced pneumonitis or other significant symptomatic deterioration of lung function
  • Live vaccines within 14 days before the first dose of study drug
  • Major surgery (as defined by the Investigator) within 4 weeks of first dose of study drug
  • Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to more than 25% of the bone marrow

Trial design

Primary purpose




Interventional model

Single Group Assignment


None (Open label)

32 participants in 1 patient group

ARV-471 and Everolimus
Experimental group
ARV-471 oral tablets in combination with everolimus administered daily in 28 day cycles
Drug: ARV-471 in combination with Everolimus

Trial contacts and locations



Central trial contact

Arvinas Estrogen Receptor, Inc.

Data sourced from

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