← Back to Search

Hormone Therapy

ARV-471 + Everolimus for Advanced Breast Cancer (TACTIVE-E Trial)

Phase 1
Waitlist Available
Research Sponsored by Arvinas Estrogen Receptor, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Women must be postmenopausal, or pre-/peri-menopausal women must be on ovarian suppression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 1 year
Awards & highlights

TACTIVE-E Trial Summary

This trial is testing a new combination drug treatment for advanced breast cancer.

Who is the study for?
This trial is for postmenopausal women or those on ovarian suppression with advanced ER+/HER2- breast cancer. Participants must have tried and not responded well to certain therapies, including a CDK 4/6 inhibitor and endocrine therapy, but not treatments targeting mTOR like everolimus. They should be in good physical condition (ECOG status of 0 or 1) and agree to use a special mouthwash to prevent sores from the medication.Check my eligibility
What is being tested?
The study tests ARV-471 combined with Everolimus in patients who've had up to three lines of previous cancer treatment. It's an early-phase trial aiming to see how safe this combination is and how it affects their type of breast cancer that has spread or cannot be surgically removed.See study design
What are the potential side effects?
Possible side effects include mouth sores which are attempted to be prevented by dexamethasone mouthwash, increased risk of infections due to immune system impact, potential lung issues such as pneumonitis, blood pressure changes requiring medication control, and possibly other heart-related complications.

TACTIVE-E Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I've had 1-3 treatments for advanced cancer, including a CDK 4/6 inhibitor and hormone therapy.
Select...
I am a woman who is either postmenopausal or taking medication to suppress my ovaries.
Select...
I am willing to use a special mouthwash to prevent mouth sores from my medication.
Select...
My breast cancer is ER+ and HER2-, and cannot be removed by surgery.
Select...
I am fully active or can carry out light work.

TACTIVE-E Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Everolimus
Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-471 in combination with everolimus
Number of participants with adverse events as a measure of safety and tolerability of ARV-471 in combination with everolimus
+1 more
Secondary outcome measures
Area under the concentration-time curve over 24 hours at steady state (AUC(0-24)) of ARV-471 and everolimus
Clinical benefit rate (CBR) in participants.
Duration of response (DOR) in participants
+3 more

TACTIVE-E Trial Design

1Treatment groups
Experimental Treatment
Group I: ARV-471 and EverolimusExperimental Treatment1 Intervention
ARV-471 oral tablets in combination with everolimus administered daily in 28 day cycles

Find a Location

Who is running the clinical trial?

Arvinas Estrogen Receptor, Inc.Lead Sponsor
16 Previous Clinical Trials
2,289 Total Patients Enrolled
7 Trials studying Breast Cancer
1,623 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,556 Previous Clinical Trials
10,907,650 Total Patients Enrolled
110 Trials studying Breast Cancer
34,638 Patients Enrolled for Breast Cancer

Media Library

ARV-471 (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05501769 — Phase 1
Breast Cancer Research Study Groups: ARV-471 and Everolimus
Breast Cancer Clinical Trial 2023: ARV-471 Highlights & Side Effects. Trial Name: NCT05501769 — Phase 1
ARV-471 (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05501769 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many different sites are implementing this research project?

"Currently, this research is occurring in 5 different settings. Nashville, Santa Monica and Lake Mary are some of the cities that have a trial site as well as other locations. If you choose to take part, it is recommended to opt for one closest to your residence so travelling demands can be minimised."

Answered by AI

Is this trial actively seeking new participants?

"Affirmative. According to the clinicaltrials.gov website, this investigation is currently recruiting participants. It was first registered on September 8th 2022 and last updated October 18th 2022, with a need for 32 patients distributed among 5 health care centres."

Answered by AI

How many subjects are currently involved in this clinical experiment?

"Affirmative. Clinicaltrials.gov reveals that this experiment, which was made available on September 8th 2022, is presently recruiting participants. 32 individuals must be recruited from 5 distinct medical facilities."

Answered by AI

To what degree is the combination of ARV-471 and Everolimus hazardous for individuals?

"The combined efficacy and safety of ARV-471 in conjunction with Everolimus has not been widely studied, so the score assigned by our team is a 1."

Answered by AI
~3 spots leftby May 2024