CX-2009 for Breast Cancer

Phase-Based Estimates
1
Effectiveness
2
Safety
Hospital Clinico Universitario de Valencia, Valencia, Spain
Breast Cancer+5 More
CX-2009 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Breast Cancer

Study Summary

This study is evaluating whether a drug called CX-2009 may help treat breast cancer.

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Eligible Conditions

  • Breast Cancer
  • Breast Neoplasms
  • Triple Negative Breast Neoplasms
  • Cancer
  • Breast Neoplasms, Hormone Receptor Positive/HER2 Negative
  • Breast Neoplasms, Triple-Negative
  • Neoplasms

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether CX-2009 will improve 1 primary outcome and 5 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of 30 months.

30 Months
Clinical Benefit Rate (CBR) at 16 Weeks
Clinical Benefit Rate (CBR) at 24 Weeks
Duration of Response (DoR)
Investigator-assessed Progression-Free Survival (PFS)
Overall Survival (OS)
30 months
Objective Response Rate (ORR)

Trial Safety

Safety Estimate

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

Trial Design

3 Treatment Groups

No Control Group
ARM C - CX-2009 Combination therapy, TNBC

This trial requires 200 total participants across 3 different treatment groups

This trial involves 3 different treatments. CX-2009 is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

ARM C - CX-2009 Combination therapy, TNBCCX-2009 and CX-072 Combination therapy in advanced, metastatic TNBC
ARM B - CX-2009 Monotherapy, TNBC
Drug
CX-2009 Monotherapy in advanced, metastatic Triple-Negative Breast Cancer (TNBC)
ARM A - CX-2009 Monotherapy, HR-positive/HER2-negative
Drug
CX-2009 Monotherapy in advanced, metastatic Hormone Receptor (HR)-positive / Human Epidermal growth factor Receptor 2 (HER2)-negative breast cancer
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CX-2009
Not yet FDA approved
CX-072
2017
Completed Phase 2
~300

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 30 months for reporting.

Closest Location

MGH - Boston, MA

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:
Arm B and Arm C: inoperable, locally advanced or metastatic TNBC; archival or fresh tumor tissue must have high CD166 expression by immunohistochemistry (IHC). Patients must have received 1 - 3 prior lines of therapy for inoperable, locally advanced, or metastatic TNBC
Arm C only: Patients must be Programmed Death Ligand 1 (PD-L1) positive by an FDA-approved test. For patients who have received prior checkpoint inhibitors (CPI) therapy: if the CPI was the most recent treatment given prior to enrollment into this study, the patient must not have progressed within 120 days of the first dose of the CPI
Measurable disease per RECIST v1.1
Adults, at least 18 years of age
Eastern Cooperative Oncology Group performance status of 0 or 1
Adequate baseline Laboratory Values
Patients of childbearing potential or those with partners of childbearing potential must agree to use a highly effective method of birth control at least 1 month prior to first dose, during study treatment, and for a period of 50 days after the last dose of CX-2009 and 105 days after the last dose of CX-072 (Arm C).
Patients with brain metastases that are ≤ 1 cm, are asymptomatic, and require no treatment may be eligible after discussion with Medical Monitor.
Additional inclusion criteria may apply
You have inoperable, locally advanced or metastatic HR-positive/HER2-negative breast cancer show original

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 causes breast cancer?

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There is no single cause of breast cancer. The combination of family history, age, ethnicity, genetic factors, and lifestyle factors can all affect breast cancer susceptibility.

Unverified Answer

Can breast cancer be cured?

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There is no evidence that one form of cancer treatment is more effective than any other in removing a cancer from the brain or in prolonging the lifespan of an individual affected by cancer. This paper, therefore, makes no claim of efficacy of any form of treatment to achieve complete remission of breast cancer except that it is an unsupported belief. Therefore, there may be no 'cure'.

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

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The current incidence of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) is increasing. More than one in two young women will be diagnosed with breast cancer. Breast cancer may become the most common form of cancer among women under age 45 by 2034.

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What are common treatments for breast cancer?

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Most women with breast cancers, particularly ERpositive tumors, are likely to benefit from surgery followed by adjuvant therapy, chemotherapy, and/or anti-estrogen medications for approximately 5 years after diagnosis. Women with large tumors (> 2 cm) may require lumpectomy, axillary lymphadenectomy, radiotherapy, or all three (combined) therapies. Women with BCS (< 1 cm with histologic positive margins for invasive tumors) may do well with simple surgery or radiation alone, but need to have periodic follow-up for ~10 years.

Unverified Answer

What is breast cancer?

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Breast cancer is a disease which can affect both women and men. It causes lump and pain in the breast, a lump which may become bigger, may feel and look like an infected lump. It can spread to surrounding tissues and spread outside the breast. Women who are diagnosed by their doctor can be treated to slow or stop the worsening of the cancer. If breast cancer is diagnosed by a screening mammogram it is easier for it to be diagnosed and treated earlier. After breast cancer is diagnosed by a screening mammogram the chance that it will occur after the woman is diagnosed is less than 1%.

Unverified Answer

What are the signs of breast cancer?

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There is often no apparent indication of breast cancer. Screening of women from the age of 35 to 75 years has been shown to reduce deaths from breast cancer, and it shows good value financially for the UK National Health Service.

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Have there been other clinical trials involving cx-2009?

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The authors conclude that there is not only a need for clinical trials using more novel combinations of drugs and delivery systems, but also for better methods to interpret and compare the results of those that have been completed.

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What is the survival rate for breast cancer?

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For people with breast cancer, there is a good risk between survival and death, although survival rates vary for people with breast cancer. There are certain factors which may affect survival rate. These include age, race, grade, tumor size, stage, and whether or not the person has had prior chemotherapy. \n

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What does cx-2009 usually treat?

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There is no clear evidence that the method of biopsy has any impact on outcomes for T1 and T2 breast cancers. There is evidence to support the role of adjuvant systemic therapy to axillary node-dense breast cancers in the absence of positive margins.

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Have there been any new discoveries for treating breast cancer?

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The first important step in the treatment of breast cancer is establishing and maintaining the standard that all newly diagnosed patients receive a lumpectomy, radiation, and, if appropriate, anti-estrogen therapy. The second step is maintaining adjuvant treatment after surgery. There have not been any adjuvant drugs approved by the Food and Drug Administration (FDA) that can reliably prolong overall survival, so there is an urgent need to identify new therapeutic approaches. The use of targeted therapies represents an opportunity for improving outcomes. Oncologists could use more research to develop therapeutic approaches that can reliably increase overall survival, and also identify drugs that can be better tolerated by patients to achieve an improved quality of life.

Unverified Answer

What are the chances of developing breast cancer?

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Based on this study, women at 40 and younger are much more likely to develop breast cancer than women of 60 or older and the vast majority of them have a 1-in-3 chance to develop breast cancer. At any given age, women appear to develop breast cancer at around the same rates. The odds of developing breast cancer before ages 20 and 40 are similar (around 1 in 2), although the odds of breast cancer appear higher at age 40 (3 in 4 women). The odds of developing breast cancer at age 50 and later are lower than at age 40 and younger (1 in 4). The risk of developing breast cancer doubles at age 50.

Unverified Answer

What are the common side effects of cx-2009?

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The side effects of Cx-2009 were minimal in the majority of patients. The most troublesome side effects included headache, vomiting, nausea, hyperbilirubinaemia, and rash. Although uncommon, serious or life-threatening hypersensitivity reactions were reported more frequently in patients on the higher-intensity Cx-2009 regimen.

Unverified Answer
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