ARX788 for Breast Cancer

Phase-Based Estimates
1
Effectiveness
2
Safety
Texas Oncology - Tyler, Tyler, TX
Breast Cancer+1 More
ARX788 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Breast Cancer

Study Summary

This study is evaluating whether a drug may help treat breast cancer.

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Eligible Conditions

  • Breast Cancer
  • Breast Neoplasms
  • HER2 Positive Metastatic Breast Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether ARX788 will improve 1 primary outcome and 11 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of Cycle 1 and cycle 3.

2 Years
Objective response rate (ORR)
2 year
Best overall response (BOR)
Overall survival (OS)
2 years
Best percent change in the sum of the longest diameters of measurable tumors
Disease control rate (DCR)
Duration of response (DOR)
Incidence of anti-drug antibodies (ADAs)
Progression-free survival (PFS)
The number of subjects experiencing adverse event TEAEs
Cycle 1 and cycle 3
Area under the serum concentration-time curve (AUC) for ARX788, total antibody, and pAF-AS269
Maximum serum concentration (Cmax) for ARX788, total antibody, and pAF-AS269
Trough concentration (Ctrough) for ARX788, total antibody, and pAF-AS269

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
HER2 positive metastatic breast cancer subjects whose disease is resistant or refractory

This trial requires 210 total participants across 2 different treatment groups

This trial involves 2 different treatments. ARX788 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

HER2 positive metastatic breast cancer subjects whose disease is resistant or refractory
Drug
This global Phase 2 study is designed to assess anticancer activity and safety of ARX788 in HER2 positive metastatic breast cancer subjects whose disease is resistant or refractory to T-DM1, and/or T-DXd, and/or tucatinib-containing regimens. The investigational medicinal product (IMP), ARX788, will be administered every 3 weeks (Q3W) by intravenous (IV) infusion.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 year for reporting.

Closest Location

Texas Oncology - Tyler - Tyler, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age ≥ 18 years and older
Subjects must have an adequate tumor sample available for confirmation of HER2 status
Life expectancy > 3 months
Eastern Cooperative Oncology Group Performance Status ≤ 1
Metastatic breast cancer subjects previously treated with T DM1, and/or T-DXd, and/or tucatinib-containing regimens.
Presence of at least one measurable lesion per RECIST v 1.1
Subjects with stable brain metastases
Acute toxicities from any prior therapy, surgery, or radiotherapy must have resolved to Grade ≤1 as per the NCI-CTCAE v 5.0, except alopecia.
Adequate organ functions
Willing and able to understand and sign an informed consent inform and to comply with all aspects of the protocol.

Patient Q&A Section

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

What is the primary cause of breast cancer?

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A primary cause of breast cancer has not yet been identified. What we have learned is that there is an association between radiation, especially in childhood, and breast cancer. Many other risk factors must be identified and studied in order to understand the cause of breast cancer.

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How many people get breast cancer a year in the United States?

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Around 19 million women get [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) a year in the United States. It accounts for 2.1% of all new cancer cases in America each year.

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What is breast cancer?

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Breast cancer is a malignant disease that starts with tumors in the breasts that appear as a lump or growth. Because it also has spread to the lymph nodes and other parts of the body before the cancer is diagnosed, breast cancer can be staged and treated. The most common form is ductal carcinoma, with the least common being triple negative (TNBC). Breast cancer can affect both women and men but the women are affected much more often than men. In the developed world, around 90% of women with breast cancers are diagnosed with early stage breast cancer. Although it is extremely rare for breast cancer to occur before age 50, more than two in three women, will develop breast cancer in their lifetime.

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What are common treatments for breast cancer?

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Common treatments for [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) include surgery, chemotherapy, radiation therapy, targeted therapy, or a combination of these. Common treatment for localized breast tumors include lumpectomy, with adjuvant radiation therapy, or neoadjuvant chemotherapy. common treatments for locally advanced breast cancer include mastectomy with reconstruction and chemotherapy, hormonal therapy, immunotherapy, or a combination of these. common treatments for metastatic breast cancer include chemotherapy, radiation therapy, targeted therapy, hormones, and surgery. Rarely, patients with a cancer to the liver or brain need more aggressive treatment.

Unverified Answer

What causes breast cancer?

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It is well accepted that the number of lifetime exposures to estrogen are of paramount importance and that lifetime andcurrent estrogen levels influence [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) risk. Although the biologic relevance of estradiol is well-documented, epidemiologic studies have established breast cancer incidence and mortality increased with higher estrogen-associated levels of plasma estradiol. Therefore, it is generally accepted that estrogen may be a causal agent for breast cancer. However, breast cancer is not the only manifestation of estrogen-related cancers. Estrogen is not necessary for benign breast disorders; the risks of benign breast disorders increase with age, or with higher circulating estrogen levels.

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What are the signs of breast cancer?

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Signs and symptoms of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) involve the breasts. Symptoms can include: lumpiness, itchiness, redness and pain. A lump is not a sign of breast cancer unless it is troubling or large. A breast

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Can breast cancer be cured?

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There are no studies directly comparing cure in [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) treatment with cure in lung cancer treatment. The most recent meta-analysis, however, supports the assumption that cure in patients with both lung and breast cancer does occur. Furthermore, in patients who achieve remission in either lung or breast cancer, the patient does not need to suffer relapse of the other cancer in the remaining lifetime.

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What are the latest developments in arx788 for therapeutic use?

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In light of positive pre-clinical studies on the effects of a combination of aldose reductase inhibitors (ARIs) with other anti-cancer agents, it seems reasonable to conclude that clinical testing of our aldose reductase inhibitor (ARI) plus other agents may be warranted.

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Is arx788 typically used in combination with any other treatments?

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Although our results are preliminary, these findings suggest that Arx788 may be more effective when in combination with standard chemotherapeutic agents, radiation, or surgery in the treatment of breast, pancreatic, or stomach diseases.

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What are the common side effects of arx788?

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One limitation of our study is that patient reported treatment-related side effects were not evaluated in this report, so our results should be interpreted with caution. Further investigations of side effects related to Arx788 are required.

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Have there been any new discoveries for treating breast cancer?

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Have newer discoveries for treating breast cancer been discovered? No. Breast cancer is a deadly disease that is treated with many options including chemotherapy, radiation therapy, and biologic therapies, but the advancement in research still needs to take an unprecedented leap.

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What is the average age someone gets breast cancer?

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The median age at diagnosis is 60 years for the UK, and 61 years in Canada. In women of all ages, the risk of developing breast cancer is ~2-fold higher in the USA and ~10-fold higher in China than in Europe or Canada. The lifetime risk is higher in the USA, but this is partly offset by younger age at diagnosis here. The lower rates in Europe may be explained by earlier detection by screening. The lower rates in China may be due to earlier diagnosis on account of more frequent testing.

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