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Hormone Therapy

ARV-471 for Breast Cancer (VERITAC-2 Trial)

Phase 3
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed diagnosis of ER+/HER2- breast cancer
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) to the date of progression or death (approximately to 2 years).
Awards & highlights

VERITAC-2 Trial Summary

This trial studies a new medicine for advanced breast cancer.

Who is the study for?
This trial is for adults with advanced metastatic breast cancer that can't be removed by surgery or treated with radiation. They should have a certain type of cancer (ER+/HER2-) and must have had specific prior treatments, including CDK4/6 inhibitors. People with severe illnesses, poor organ function, high-risk visceral disease, previous ARV-471 treatment or similar drugs are not eligible.Check my eligibility
What is being tested?
The study tests a new drug called ARV-471 against Fulvestrant in treating advanced breast cancer. Participants will receive one of these treatments to see how well they work and compare their effects on the disease.See study design
What are the potential side effects?
Possible side effects include typical reactions to cancer medications such as nausea, fatigue, blood count changes, liver and kidney function alterations. The exact side effects of ARV-471 are being studied but may be similar to other drugs in its class.

VERITAC-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My breast cancer is ER positive and HER2 negative.
Select...
I am fully active or can carry out light work.
Select...
My breast cancer has returned or spread and cannot be removed by surgery or treated with radiation.

VERITAC-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) to the date of progression or death (approximately to 2 years).
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) to the date of progression or death (approximately to 2 years). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Clinical Benefit Rate
Clinical Pain and its impact on functioning will be assessed using Brief Pain Inventory Short Form (BPI-SF) questionnaire.
Disease- and treatment-related Quality of Life will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) breast cancer module (QLQ-BR23) questionnaire
+9 more

Side effects data

From 2016 Phase 2 & 3 trial • 12 Patients • NCT02116803
50%
DECREASED APPETITE
30%
CONSTIPATION
30%
DIARRHOEA
30%
PAIN IN EXTREMITY
30%
RASH
20%
NASOPHARYNGITIS
20%
FATIGUE
20%
ANAEMIA
20%
ANGINA PECTORIS
20%
OEDEMA PERIPHERAL
20%
GAMMA-GLUTAMYLTRANSFERASE INCREASED
20%
HEADACHE
20%
COUGH
10%
GASTROOESOPHAGEAL REFLUX DISEASE
10%
INFLUENZA
10%
ASPARTATE AMINOTRANSFERASE INCREASED
10%
BLOOD CREATININE INCREASED
10%
HYPERTRIGLYCERIDAEMIA
10%
NAUSEA
10%
PLATELET COUNT DECREASED
10%
CONTUSION
10%
BLOOD ALKALINE PHOSPHATASE INCREASED
10%
LYMPHOCYTE COUNT DECREASED
10%
DYSPEPSIA
10%
DRY MOUTH
10%
PNEUMONIA
10%
HERPES ZOSTER
10%
ARTHRALGIA
10%
HYPOCALCAEMIA
10%
HYPERKALAEMIA
10%
EYE OEDEMA
10%
BRADYCARDIA
10%
CORONARY ARTERY DISEASE
10%
MYOCARDIAL ISCHAEMIA
10%
PLEURAL EFFUSION
10%
PNEUMOTHORAX
10%
INCREASED TENDENCY TO BRUISE
10%
LEUKOPENIA
10%
NEUTROPENIA
10%
HYPOTHYROIDISM
10%
ABDOMINAL PAIN
10%
ASTHENIA
10%
FACE OEDEMA
10%
PYREXIA
10%
INTERNATIONAL NORMALISED RATIO INCREASED
10%
ARTHRITIS
10%
MUSCLE SPASMS
10%
MUSCULOSKELETAL PAIN
10%
NEURALGIA
10%
INSOMNIA
10%
RESTLESSNESS
10%
DYSPNOEA
10%
DYSPNOEA EXERTIONAL
10%
PRODUCTIVE COUGH
10%
PRURITUS
10%
SKIN LESION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dovitinib
Dovitinib+Fulvestrant

VERITAC-2 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ARV-471Experimental Treatment1 Intervention
Group II: FulvestrantActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ARV-471
2022
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,570 Previous Clinical Trials
10,909,880 Total Patients Enrolled
111 Trials studying Breast Cancer
36,404 Patients Enrolled for Breast Cancer
Arvinas Estrogen Receptor, Inc.Industry Sponsor
17 Previous Clinical Trials
1,809 Total Patients Enrolled
8 Trials studying Breast Cancer
1,655 Patients Enrolled for Breast Cancer
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,475 Previous Clinical Trials
8,090,994 Total Patients Enrolled
43 Trials studying Breast Cancer
12,808 Patients Enrolled for Breast Cancer

Media Library

ARV-471 (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05654623 — Phase 3
Breast Cancer Research Study Groups: ARV-471, Fulvestrant
Breast Cancer Clinical Trial 2023: ARV-471 Highlights & Side Effects. Trial Name: NCT05654623 — Phase 3
ARV-471 (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05654623 — Phase 3

Frequently Asked Questions

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

What regulatory clearance has ARV-471 achieved?

"ARV-471 has been assessed as safe with a score of 3 due to the multiple rounds of evidence in both efficacy and safety that have arisen from this Phase 3 trial."

Answered by AI

How many study sites are conducting this experiment?

"The 8 trial locations recruiting patients for this study include the Mid Florida Hematology and Oncology Center in Orange City, BRCR Global in Plantation, and Hematology-Oncology Associates of Central New york PC in East Syracuse. There are also additional sites looking for participants."

Answered by AI

Is there still capacity available for participants in this clinical investigation?

"It appears that the trial, which was initially listed on December 30th 2022 and last edited a day later is no longer actively recruiting. Luckily, there are 2197 other clinical trials currently seeking volunteers to join their research teams."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
What site did they apply to?
Tennessee Oncology, PLLC
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Recent research and studies
clinicaltrials.govStudy
A Study to Learn About a New Medicine Called ARV-471 (PF-07850327) in People Who Have Advanced Metastatic Breast Cancer.
2023. "A Study to Learn About a New Medicine Called ARV-471 (PF-07850327) in People Who Have Advanced Metastatic Breast Cancer.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05654623.
All > Breast Cancer Las Vegas
~99 spots leftby Aug 2024
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