Breast CancerPhase 1TACTIVE-ENCT05501769
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
A Phase 1 study testing ARV-471 in combination with Everolimus in people with Breast Cancer, run by Arvinas Estrogen Receptor, Inc. at 9 sites in 2 countries.
Trial summary
A phase 1b study to assess the combination of ARV-471 and everolimus in participants with advanced or metastatic ER+/HER2- breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ARV-471 in combination with Everolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 8 Sep 2022to 25 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States6 sites
Clinical Trial Site
Ann Arbor, Michigan, 48109
Clinical Trial Site
Lake Mary, Florida, 32746
Clinical Trial Site
Nashville, Tennessee, 37203
Clinical Trial Site
San Diego, California, 92037
Clinical Trial Site
Santa Monica, California, 90404
Clinical Trial Site
Washington D.C., District of Columbia, 20007
Spain3 sites
Clinical Trial Site
Barcelona, 08028
Clinical Trial Site
Madrid, 28034
Clinical Trial Site
Valencia, 46018
About this study
Official title: A Phase 1b Trial of ARV-471 in Combination With Everolimus in Patients With ER+, HER2- Advanced or Metastatic Breast Cancer
A phase 1b study to assess the combination of ARV-471 and everolimus in participants with advanced or metastatic ER+/HER2- breast cancer.
Read the detailed 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.
- Conditions
- Breast Cancer
- Being tested
- ARV-471 in combination with Everolimus
- Keywords
- Advanced breast cancer, Metastatic breast cancer, MBC, Endocrine therapy, Estrogen receptor, ER+, human epidermal growth factor receptor 2, HER2-, ARV-471, Everolimus, PROTAC, Vepdegestrant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARV-471 in combination with EverolimusDrug
ARV-471 oral tablets in combination with everolimus administered daily in 28 day cycles
| Study group | Role | What they receive |
|---|---|---|
| ARV-471 and Everolimus | Experimental | ARV-471 oral tablets in combination with everolimus administered daily in 28 day cycles Receives: Drug: ARV-471 in combination with Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicities of ARV-471 in combination with everolimus
Dose limiting toxicities in the first 35 days of the study combination treatment characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), timing, seriousness, and relationship to study drug
Measured: 35 Days
Recommended Phase 2 Dose (RP2D) for ARV-471 in combination with everolimus
Measured: 35 Days
Number of participants with adverse events as a measure of safety and tolerability of ARV-471 in combination with everolimus
Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug combination
Measured: 28 calendar days after participant discontinues study treatment
Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-471 in combination with everolimus
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), and timing
Measured: 28 calendar days after participant discontinues study treatment
Secondary outcomes (6)
Overall response rate (ORR) in participants
Measured: Up to approximately 1 year
Clinical benefit rate (CBR) in participants.
Clinical benefit response rate based on the summation of CRs, PRs and stable disease of 24 weeks duration or longer.
Measured: Up to approximately 1 year
Duration of response (DOR) in participants
Measured: Up to approximately 1 year
Maximum plasma concentrations (Cmax) of ARV-471 and everolimus
Measured: At predefined intervals throughout the treatment period, up to approximately 4 weeks after last dose of investigational products
Time to maximum plasma concentrations (Tmax) of ARV-471 and everolimus
Measured: At predefined intervals throughout the treatment period, up to approximately 4 weeks after last dose of investigational products
Area under the concentration-time curve over 24 hours at steady state (AUC(0-24)) of ARV-471 and everolimus
Measured: At predefined intervals throughout the treatment period, up to approximately 4 weeks after last dose of investigational products
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start8 Sep 2022
- Primary completion3 Jul 2024
- Study completion25 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arvinas Estrogen Receptor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501769
- Sponsor's protocol ID
- ARV-471-mBC-102
- Other IDs
- C4891020
- Acronym
- TACTIVE-E
- Status last verified
- Sep 2025
- First submitted
- 9 Aug 2022
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Trial of ARV-471 in Combination With Everolimus in Patients With ER+, HER2- Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT05501769
- Acronym / sponsor ID
- TACTIVE-E / ARV-471-mBC-102
- Conditions
- Breast Cancer
- Keywords
- Advanced breast cancer, Metastatic breast cancer, MBC, Endocrine therapy, Estrogen receptor, ER+, human epidermal growth factor receptor 2, HER2-
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Arvinas Estrogen Receptor, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 25 Aug 2025 (actual)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 1b study to assess the combination of ARV-471 and everolimus in participants with advanced or metastatic ER+/HER2- breast cancer.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARV-471 and Everolimus | Experimental | Drug: ARV-471 in combination with EverolimusARV-471 oral tablets in combination with everolimus administered daily in 28 day cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARV-471 in combination with EverolimusARV-471 oral tablets in combination with everolimus administered daily in 28 day cycles | Drug | ARV-471 and Everolimus |
Primary outcome
Incidence of dose limiting toxicities of ARV-471 in combination with everolimus
Time frame: 35 Days
Dose limiting toxicities in the first 35 days of the study combination treatment characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), timing, seriousness, and relationship to study drug
Recommended Phase 2 Dose (RP2D) for ARV-471 in combination with everolimus
Time frame: 35 Days
Number of participants with adverse events as a measure of safety and tolerability of ARV-471 in combination with everolimus
Time frame: 28 calendar days after participant discontinues study treatment
Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug combination
Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-471 in combination with everolimus
Time frame: 28 calendar days after participant discontinues study treatment
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), and timing
6 secondary outcomes
Overall response rate (ORR) in participants
Time frame: Up to approximately 1 year
Clinical benefit rate (CBR) in participants.
Time frame: Up to approximately 1 year
Duration of response (DOR) in participants
Time frame: Up to approximately 1 year
Maximum plasma concentrations (Cmax) of ARV-471 and everolimus
Time frame: At predefined intervals throughout the treatment period, up to approximately 4 weeks after last dose of investigational products
Time to maximum plasma concentrations (Tmax) of ARV-471 and everolimus
Time frame: At predefined intervals throughout the treatment period, up to approximately 4 weeks after last dose of investigational products
Area under the concentration-time curve over 24 hours at steady state (AUC(0-24)) of ARV-471 and everolimus
Time frame: At predefined intervals throughout the treatment period, up to approximately 4 weeks after last dose of investigational products
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ARV-471 in combination with Everolimus in people with Breast Cancer, run by Arvinas Estrogen Receptor, Inc. at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicities of ARV-471 in combination with everolimus (time frame: 35 Days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.