What is the mechanism of action of this treatment?

Common treatments for ER+/HER2- breast cancer include endocrine therapies and targeted treatments. Endocrine therapies, such as aromatase inhibitors (e.g., letrozole, anastrozole) and selective estrogen receptor modulators (e.g., tamoxifen), work by reducing estrogen levels or blocking estrogen receptors, thereby inhibiting the growth of hormone-dependent cancer cells. Targeted treatments, like CDK 4/6 inhibitors (e.g., palbociclib) and mTOR inhibitors (e.g., everolimus), disrupt specific signaling pathways that cancer cells use to proliferate. These mechanisms are vital for breast cancer patients as they offer more personalized and effective treatment options, potentially leading to better outcomes and prolonged survival.

What side effects are associated with this type of intervention?

Common treatments for ER+/HER2- breast cancer, such as tamoxifen and aromatase inhibitors, often lead to side effects like hot flashes, bone density loss, and cardiovascular risks. Tamoxifen can also cause hair thinning and has been associated with poor adherence due to its side effects. Aromatase inhibitors, like anastrozole, may result in bone fractures and cardiovascular issues. Targeted therapies, such as the combination of lapatinib and letrozole, can cause diarrhea and rash. These side effects should be discussed with a healthcare provider to manage and mitigate their impact.

What prior FDA approvals exist?

Prior FDA approvals for the treatment of ER+/HER2- breast cancer include aromatase inhibitors like letrozole and anastrozole, which reduce estrogen levels, and CDK 4/6 inhibitors such as abemaciclib, often used in combination with endocrine therapy. Fulvestrant, a selective estrogen receptor degrader, is also approved for this subtype. These treatments target estrogen receptors or related pathways, similar to the investigational drug AC699 being studied in the trial.

What other types of research exist?

Promising novel alternatives to AC699 for ER+/HER2- breast cancer patients include CDK4/6 inhibitors such as palbociclib, ribociclib, and abemaciclib, which have shown efficacy in prolonging progression-free survival. Additionally, combining CDK4/6 inhibitors with endocrine therapy or other targeted therapies like mTOR inhibitors (e.g., everolimus) may offer enhanced benefits. Investigational agents targeting the PI3K/AKT/mTOR pathway, such as alpelisib, also represent potential alternatives.

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Selective Estrogen Receptor Modulator

AC699 for Breast Cancer

Phase 1

Recruiting

Research Sponsored by Accutar Biotechnology Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed diagnosis of advanced, unresectable, and/or metastatic breast cancer following disease progression on standard treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to standard therapies

Female participants must be postmenopausal

Must not have

Treatment with any cytotoxic chemotherapy, investigational agents or other anti-cancer drugs for the treatment of locally advanced or metastatic breast cancer within 14 days prior to the first administration of AC699

Any condition that impairs a participant's ability to swallow whole pills. Impairment of gastrointestinal function (GI) or GI disease or other condition at baseline that will interfere significantly with the absorption, distribution, or metabolism of AC699

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 18 months.

Awards & highlights

Summary

This trial is testing a drug for breast cancer to determine its safety, dosage and effectiveness.

Who is the study for?

This trial is for adults with ER+/HER2- advanced or metastatic breast cancer who have tried at least one line of endocrine therapy. They must be able to swallow pills, have no major GI issues affecting drug absorption, and should not have symptomatic brain metastases requiring high-dose steroids.Check my eligibility

What is being tested?

The study tests AC699's safety, tolerable dosing levels, how the body processes it (pharmacokinetics), and its effectiveness in treating breast cancer. Participants will receive AC699 to determine these outcomes.See study design

What are the potential side effects?

While specific side effects of AC699 are not listed here, common ones may include reactions at the pill intake site, gastrointestinal disturbances due to oral administration, fatigue from treatment burden, and potential organ-specific inflammation.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer is advanced, can't be surgically removed, and has worsened after standard treatment.

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I have gone through menopause.

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I have at least one tumor that can be measured or a specific type of bone lesion.

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My breast cancer is ER+ and HER2-.

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I have had at least 2 hormone therapies or 1 with a CDK4/6 inhibitor for my cancer.

Exclusion Criteria

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

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I haven't taken any cancer drugs for my advanced breast cancer in the last 14 days.

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I can swallow pills without difficulty and don't have major GI issues affecting medication absorption.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 18 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 18 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 18 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of dose limiting toxicities (DLTs) from AC699 monotherapy

Incidence of treatment-emergent adverse events (TEAEs) and clinically significant Grade 3 or higher lab abnormalities following administration of AC699

Secondary outcome measures

Clinical Benefit Rate (CBR) to assess the anti-tumor activity of AC699 using RECIST 1.1

Disease Control Rate (DCR) to assess the anti-tumor activity of AC699 using RECIST 1.1

Duration of Response (DOR) to assess the anti-tumor activity of AC699 using RECIST 1.1

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: AC699 Dose EscalationExperimental Treatment1 Intervention

Participants will receive an assigned dose of AC699 monotherapy during dose escalation. One cycle is defined as 28 days.

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 ER+/HER2- breast cancer include endocrine therapies and targeted treatments. Endocrine therapies, such as aromatase inhibitors (e.g., letrozole, anastrozole) and selective estrogen receptor modulators (e.g., tamoxifen), work by reducing estrogen levels or blocking estrogen receptors, thereby inhibiting the growth of hormone-dependent cancer cells. Targeted treatments, like CDK 4/6 inhibitors (e.g., palbociclib) and mTOR inhibitors (e.g., everolimus), disrupt specific signaling pathways that cancer cells use to proliferate. These mechanisms are vital for breast cancer patients as they offer more personalized and effective treatment options, potentially leading to better outcomes and prolonged survival.

Progesterone receptor assembly of a transcriptional complex along with activator protein 1, signal transducer and activator of transcription 3 and ErbB-2 governs breast cancer growth and predicts response to endocrine therapy.New concepts in breast cancer therapy.Resistance to endocrine therapy in breast cancer: exploiting estrogen receptor/growth factor signaling crosstalk.