What is the mechanism of action of this treatment?

Common treatments for hormone receptor-positive, HER2-negative breast cancer, such as estrogen receptor antagonists, work by blocking the effects of estrogen on cancer cells. This is crucial because many breast cancers rely on estrogen to grow. By inhibiting this pathway, these treatments can slow or stop tumor growth. This understanding is vital for selecting effective therapies and managing resistance, ultimately improving patient outcomes.

What side effects are associated with this type of intervention?

Common treatments for ER-positive, HER2-negative breast cancer, such as tamoxifen and aromatase inhibitors, have well-documented side effects. Tamoxifen can cause hot flashes, increased risk of thromboembolic events, and endometrial cancer. Aromatase inhibitors, like anastrozole, are associated with bone density loss, increased fracture risk, and cardiovascular issues. Both treatments aim to reduce estrogen's effect on breast cancer cells but come with these potential adverse effects that should be discussed with a healthcare provider.

What prior FDA approvals exist?

FDA-approved treatments for estrogen receptor-positive, HER2-negative breast cancer include several estrogen receptor antagonists and other endocrine therapies. Tamoxifen, a selective estrogen receptor modulator, has been widely used for decades. Aromatase inhibitors such as anastrozole, letrozole, and exemestane are also commonly prescribed for postmenopausal women. Fulvestrant, a selective estrogen receptor degrader, is another option for patients who have progressed on prior endocrine therapy. These treatments aim to block or reduce estrogen's effects on breast cancer cells, similar to the investigational drug AND019.

What other types of research exist?

Promising alternatives to AND019 for ER+ breast cancer patients include aromatase inhibitors like anastrozole, CDK4/6 inhibitors such as abemaciclib, and combination therapies involving these agents. These treatments have shown efficacy in clinical trials and are viable options for patients considering treatment in 2024.

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Small Molecule Inhibitor

AND019 for Breast Cancer

Phase 1

Recruiting

Research Sponsored by Kind Pharmaceuticals LLC

Eligibility Criteria Checklist

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

Must have

Histological or cytological confirmation of advanced or metastatic ER+/HER2- breast cancer women who failed standard therapy or for which no standard therapy exists

ECOG score 0-1

Must not have

Previous treatment with any SERDs

Patient who had major surgery or significant trauma within 4 weeks prior to the first dose of study drug (excluding needle biopsy), or has scheduled surgery during the study period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from treatment start date until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called AND019 to see if it is safe and effective for postmenopausal women with a specific type of advanced breast cancer. The study will look at how the drug moves through the body and its effects on cancer cells.

Who is the study for?

This trial is for postmenopausal women with advanced or metastatic ER+/HER2- breast cancer who have failed standard therapy or have no standard options left. They should be relatively healthy (ECOG score 0-1), have a life expectancy of at least 3 months, and must not have had more than one chemotherapy for advanced breast cancer.

What is being tested?

AND019 PO QD is being tested to see how safe it is, how the body processes it, and if it works against certain types of breast cancer. This study includes increasing doses to find the right amount and will also look at its effects on tumor activity in participants.

What are the potential side effects?

Specific side effects are not listed here, but generally, this type of trial looks out for any new symptoms that could range from mild discomforts like nausea to more serious conditions affecting organ function which would be monitored closely.

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+ and HER2-, and standard treatments haven't worked.

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I am fully active or can carry out light work.

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I have had only one chemotherapy treatment for advanced breast cancer.

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My cancer returned or worsened after endocrine therapy but I initially benefited from it.

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I am considered postmenopausal according to current guidelines.

Exclusion Criteria

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

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I have been treated with SERDs before.

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I haven't had major surgery or significant injury in the last 4 weeks and have no planned surgeries.

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My cancer has spread to my brain.

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I have another cancer besides this one that is getting worse or needs treatment.

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I have an active infection and am on antibiotics or antivirals.

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I have HIV, syphilis, hepatitis B or C without effective treatment.

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I haven't used strong CYP3A inhibitors, inducers, or consumed grapefruit in the last 4 weeks.

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I have heart problems or a history of heart issues.

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I still have significant side effects from past cancer treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from treatment start date until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from treatment start date until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from treatment start date until the date of first documented progression or date of death from any cause, whichever came first, assessed up 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

Number of participants with adverse events by severity, according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0

PK study of AND019

Secondary study objectives

Clinical Benefit Rate

Determine the RP2D

Duration of Response

+1 more

Other study objectives

PD study of AND019 in blood samples

Body tissue

Progression free survival

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: AND019 single dose escalation and expansionExperimental Treatment1 Intervention

Subjects will be administrated with AND019 capsule PO QD from 20 mg to 400 mg during Part 1, and 2 dose groups will be selected for dose expansion study

0 / 14Eligibility 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 hormone receptor-positive, HER2-negative breast cancer, such as estrogen receptor antagonists, work by blocking the effects of estrogen on cancer cells. This is crucial because many breast cancers rely on estrogen to grow. By inhibiting this pathway, these treatments can slow or stop tumor growth. This understanding is vital for selecting effective therapies and managing resistance, ultimately improving patient outcomes.

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