What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly hormone receptor-positive types, include endocrine therapies like aromatase inhibitors and tamoxifen, and targeted therapies such as CDK4/6 inhibitors. Aromatase inhibitors can cause reversible grade 1 alopecia in 10-34% of patients, while tamoxifen has a 25% incidence of alopecia, with most cases occurring within the first 12 months. CDK4/6 inhibitors, when combined with endocrine therapies, can increase the risk of alopecia. Molecularly targeted agents, such as EGFR inhibitors, can cause a range of cutaneous symptoms including acneiform rash, hirsutism, pruritus, and dry skin, collectively known as PRIDE. These side effects are generally reversible but can occasionally lead to scarring alopecia.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer that target hormone receptors, similar to ARV-471. Notable examples include tamoxifen, a selective estrogen receptor modulator (SERM), and fulvestrant, a selective estrogen receptor degrader (SERD). Additionally, aromatase inhibitors like letrozole and anastrozole are used to reduce estrogen levels in postmenopausal women. For HER2-positive breast cancer, the FDA has approved trastuzumab and pertuzumab. PARP inhibitors such as olaparib have also been approved for patients with BRCA mutations. These treatments collectively offer a range of options for managing different subtypes of breast cancer.

What other types of research exist?

Promising alternatives to ARV-471 for breast cancer treatment include ALM201, which inhibits endocrine therapy-resistant cancer stem cells and delays tumor recurrence, and the combination of R115,777 with anti-estrogens like tamoxifen or ICI182,780, which enhances inhibition of ER-positive breast tumors. These therapies have shown efficacy in preclinical and clinical studies and may offer new options for patients in 2024.

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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

Must not have

Inadequate liver, kidney and bone marrow function

Prior treatment with ARV-471, fulvestrant, elacestrant, mTOR, PI3K, AKT pathway inhibitors, PARP inhibitor for any setting, other investigational agents (including novel endocrine therapy any SERDs, SERCAs, CERANs) for any setting, or prior chemotherapy for advanced/metastatic disease

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

Pivotal Trial

No Placebo-Only Group

Summary

This trial tests a new oral medicine, ARV-471, against an existing injectable treatment, fulvestrant, in people with advanced breast cancer that has spread. Both medicines aim to slow cancer growth by targeting estrogen receptors. ARV-471 is developed as an oral alternative to fulvestrant.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is ER positive and HER2 negative.

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I am fully active or can carry out light work.

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My breast cancer has returned or spread and cannot be removed by surgery or treated with radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver, kidneys, and bone marrow are not working well.

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I haven't taken specific cancer treatments like ARV-471, fulvestrant, or chemotherapy for advanced disease.

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My cancer has spread to my organs and is causing symptoms that could be life-threatening soon.

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I have active cancer spread to my brain.

Timeline

Screening ~ 3 weeks3 visits

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).

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival (PFS)

Secondary study objectives

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 2023 Phase 1 trial • 12 Patients • NCT05652660

Abdominal pain

100%

80%

60%

40%

20%

Study treatment Arm

Period 1: Rosuvastatin

Period 2: ARV-471 + Rosuvastatin

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 2

~190

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include endocrine therapy, chemotherapy, and targeted therapy. Endocrine therapy, particularly relevant for hormone receptor-positive breast cancer, includes Selective Estrogen Receptor Degraders (SERDs) like ARV-471. SERDs bind to estrogen receptors and promote their degradation, inhibiting the estrogen-driven growth of cancer cells. This mechanism is crucial for patients with hormone receptor-positive breast cancer as it directly targets the hormonal pathways that fuel tumor growth, allowing for more personalized and effective treatment plans.

Molecular mechanisms of endocrine resistance and their implication in the therapy of breast cancer.