What side effects are associated with this type of intervention?

Common treatments for ER+/HER2- breast cancer, such as tamoxifen and aromatase inhibitors, often have side effects including hot flashes, fatigue, and an increased risk of blood clots. Tamoxifen can also cause endometrial cancer and cataracts. Aromatase inhibitors are associated with bone density loss, fractures, and cardiovascular risks. Newer agents like AC682, which are still under investigation, aim to minimize these side effects while effectively targeting cancer cells.

What prior FDA approvals exist?

For the treatment of ER+/HER2- breast cancer, the FDA has approved several drugs targeting estrogen receptors and related pathways. Aromatase inhibitors like letrozole, anastrozole, and exemestane reduce estrogen production and are commonly used in postmenopausal women. Additionally, CDK 4/6 inhibitors such as palbociclib, ribociclib, and abemaciclib, often combined with endocrine therapy, have shown efficacy in improving progression-free survival. These treatments are designed to inhibit cancer cell proliferation by targeting the cell cycle and hormonal pathways.

What other types of research exist?

Promising alternatives to AC682 for ER+/HER2- breast cancer include EM-800 (acolbifene), everolimus plus exemestane, and combinations involving R115,777. These treatments target estrogen receptors or related pathways and have demonstrated efficacy and safety in clinical trials.

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Other

AC682 for Advanced Breast Cancer

Phase 1

Waitlist Available

Research Sponsored by Accutar Biotechnology Inc

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1

Histologically and/or cytologically confirmed advanced estrogen receptor positive (ER+) human epidermal growth factor 2 negative (HER2-) breast cancer

Must not have

Treatment with any systemic small molecules from a previous treatment regimen or clinical study within 14 days or 5 half-lives (whichever is longer) prior to the first dose of AC682 (at least 10 days must have elapsed between the last dose of such agent and the first dose of study drug)

Major surgery (excluding placement of vascular access) within 4 weeks of first dose of AC682

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, approximately 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new oral drug called AC682 for patients with advanced breast cancer that grows in response to estrogen. The drug aims to break down estrogen receptors on cancer cells to stop their growth.

Who is the study for?

This trial is for postmenopausal women over 18 with advanced ER+/HER2- breast cancer, who are in good health with a life expectancy of at least 3 months. They must have measurable cancer lesions and not have had recent cancer treatments or surgeries, nor any condition affecting drug absorption.

What is being tested?

AC682 is being tested to find the safest dose, understand side effects, how the body processes it (pharmacokinetics), and its effectiveness against advanced ER+/HER2- breast cancer. Participants will receive AC682 as part of this evaluation process.

What are the potential side effects?

While specific side effects of AC682 aren't listed here, common ones may include reactions at the injection site, fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding tendencies. Each participant's experience can vary.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or have some restrictions but can still care for myself.

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My breast cancer is ER+ and HER2-.

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I am 18 years old or older.

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I am a woman and have gone through menopause.

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 from a study or past treatment in the last 14 days or more.

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I have not had major surgery in the last 4 weeks.

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I have not had major radiation therapy within the last 28 days.

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I have a stomach or intestine problem that affects how medicines work in my body.

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I am taking steroids for brain metastases symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, approximately 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, approximately 18 months

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

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of treatment-emergent adverse events (TEAEs), and clinically significant grade 3 or higher laboratory abnormalities following administration of AC682

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: AC682Experimental Treatment1 Intervention

This arm will evaluate AC682 monotherapy administered in 28-day cycles. Up to 30 participants will participate in this dose escalation arm.

0 / 9Eligibility 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 selective estrogen receptor modulators (SERMs) like tamoxifen, aromatase inhibitors (AIs) such as letrozole and anastrozole, and selective estrogen receptor degraders (SERDs) like fulvestrant. These therapies work by blocking the estrogen receptor, reducing estrogen production, or degrading the receptor, thereby inhibiting the growth of estrogen-dependent cancer cells. This is crucial for patients with ER+/HER2- breast cancer as these tumors rely on estrogen signaling for growth and proliferation. Understanding these mechanisms helps in tailoring effective treatment plans and managing resistance to therapy.

Exploring the Molecular Mechanism of the Drug-Treated Breast Cancer Based on Gene Expression Microarray.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.Resistance to endocrine therapy in breast cancer: exploiting estrogen receptor/growth factor signaling crosstalk.