CLINICAL TRIAL

Laboratory Biomarker Analysis for Breast Cancer

Metastatic
Stage I
Recruiting · 18+ · All Sexes · Baton Rouge, LA

This study is evaluating whether a drug used to treat high blood pressure and heart failure may help prevent heart damage in patients with breast cancer.

See full description

About the trial for Breast Cancer

Eligible Conditions
HER2/Neu Positive · Stage IV Breast Cancer AJCC v6 and v7 · Recurrent Breast Carcinoma · Cardiotoxicity · Breast Neoplasms · Neoplasms · Metastatic Malignant Neoplasm in the Brain

Treatment Groups

This trial involves 3 different treatments. Laboratory Biomarker Analysis 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 3 and have had some early promising results.

Experimental Group 1
Laboratory Biomarker Analysis
OTHER
+
Carvedilol
DRUG
Control Group 2
Laboratory Biomarker Analysis
OTHER
+
Patient Observation
OTHER
Control Group 3
Laboratory Biomarker Analysis
OTHER

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carvedilol
FDA approved

Eligibility

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Trastuzumab + chemotherapy or hormonal therapy
Trastuzumab + other HER-2 targeted agent with or without chemotherapy (such as pertuzumab)
Ado-trastuzumab (Kadcyla)
NOTE: Patients on lapatinib without trastuzumab are not eligible; planned treatment with concurrent HER-2 targeted therapy and anthracyclines is not permitted
Previous anthracycline exposure, OR Left ventricular ejection fraction (LVEF) 50-54% by local echocardiography (ECHO) read
Age >= 65
Body mass index (BMI) >= 30 kg/m^2
STEP 1 REGISTRATION
Trastuzumab
Current or prior anti-hypertensive therapy
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 108 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 108 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 108 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Laboratory Biomarker Analysis will improve 1 primary outcome and 5 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of Up to 108 weeks.

Time to first occurrence of cardiac event
UP TO 108 WEEKS
any of the following treating physician documented events requiring hospitalization or medical treatment, and subsequent temporary or permanent discontinuation of trastuzumab- based HER-2 targeted therapy: arrhythmia, unstable angina, non-ST segment elevated myocardial infarction, myocardial infarction, or congestive heart failure.
UP TO 108 WEEKS
Incidence of adverse events associated with beta blocker treatment
UP TO 108 WEEKS
Adverse events associated with beta blocker treatment will be assessed.
UP TO 108 WEEKS
Drug adherence
UP TO 108 WEEKS
Patients on the active arm will be asked to record study drug consumption on a monthly intake calendar. Amount of study drug taken among patients randomized to the active arm and study drug adoption among patients randomized to the no intervention arm (i.e., contamination) will be recorded by study site staff on a case report form at each follow-up visit to assess the sensitivity of the primary treatment effect to observed conditions.
UP TO 108 WEEKS
Rate of first interruption of trastuzumab
UP TO 108 WEEKS
The distributions of time to interruption of trastuzumab-based therapy will be described using cumulative incidence estimates, with the statistical significance of treatment arm differences assessed by Cox and Fine-Gray regression models with adjustment for stratification factors. Gray?s test will also be applied to the primary endpoint to assess whether the results are sensitive to different model assumptions.
UP TO 108 WEEKS
Time to the first identification of cardiac dysfunction
UP TO 108 WEEKS
Real-time, blinded, central echocardiography (ECHO) read as a decrease in the left ventricular ejection fraction (LVEF) of >= 10 percentage points from baseline to a value of < 50% OR decrease of LVEF by >= 5 percentage points from baseline to LVEF < 50% in those baselines having a baseline LVEF of 50-54%. The distributions of time to cardiac dysfunction will be described using cumulative incidence estimates, with the statistical significance of treatment arm differences assessed by Cox and Fine-Gray regression models with adjustment for stratification factors. Gray's test will also be applied
UP TO 108 WEEKS
Rate of death
UP TO 108 WEEKS
Will compare rate of death from competing causes between treatment arms via Cox regression to evaluate whether those rates impact the primary analysis comparison.
UP TO 108 WEEKS

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?

Breast cancer develops as a result of genetic alterations of tumor suppressive genes and over-activation of cell proliferation genes, occurring in cells with no overt mutational changes in DNA. These genetic alterations contribute to predisposition to breast cancer by making these women particularly vulnerable to the effects of risk factors such as estrogen receptor signaling.

Anonymous Patient Answer

What are common treatments for breast cancer?

The decision to treat [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) can be difficult because many medical conditions require treatment regardless of prognosis. However, most women receive some form of surgery prior to treatment with chemotherapy and other treatments. Also, medical research continues to refine treatments with improved outcomes. Given the large number of treatments provided for cancer, these guidelines should provide guidance on where the best therapy is chosen.

Anonymous Patient Answer

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

In 2018, an estimated 174,750 new diagnoses of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) were made. This represents 2.8% of all new cancer diagnoses in the United States. These data highlight the need for better patient education regarding the disease and mammography screening.

Anonymous Patient Answer

What are the signs of breast cancer?

Breast cancer in women of reproductive age can cause many painful symptoms. These painful symptoms are much more likely to occur when the breast cancer is new, is localized and/or has metastasized. When present at screening in women 30 to fifty years ago, the signs of breast cancer also included non-painful symptoms, which has led to questions about why women without these symptoms had the screening done.

Anonymous Patient Answer

Can breast cancer be cured?

When patients receive adequate and adequate timely treatment in the first stages of the disease, and when their cancers have not spread or recurred, it is possible that a cure is achievable.

Anonymous Patient Answer

What is breast cancer?

Breast cancer typically appears when a woman is between 25 and 50 years old and usually forms in the breast near the chest. Treatment involves an operation to remove the tumor and may also involve surgery for reconstruction of the breast to look the same. Progression of the disease may lead to lymph node involvement, and can ultimately result in the spread of disease to other parts of the body. Breast cancer is diagnosed by checking the breasts for any abnormal or unusual lump.

Anonymous Patient Answer

Does breast cancer run in families?

There are numerous families who are affected by breast cancer with clustering for both breast cancer prevalence and BC risk. These patterns may be explained by rare genetic alterations or by environmental exposures.

Anonymous Patient Answer

Have there been any new discoveries for treating breast cancer?

In the last decade breast-cancer researchers have developed several new treatments. The advent of the targeted therapies have changed the outlook for some breast-cancer patients. However, more research is needed, mainly in patients without receptor-positive cancers, as these cancers are notoriously difficult to treat with hormonal and/or chemotherapeutic agents.

Anonymous Patient Answer

How serious can breast cancer be?

There is a strong connection between cancer and cancer mortality. But overall, breast cancer is very rare in women. Women, especially in the younger age groups, often have a low body mass index. The breast cancer mortality in young women is higher than expected rates. There is also a high mortality of young girls, of course this is largely due to the screening and early detection programs. The rate of young women with cancer is increasing. There is also a high rate of lymph node involvement. And this poses a greater health risk. The stage at which a cancer is discovered is very important in determining the outcome, especially for breast cancer.

Anonymous Patient Answer

What is the survival rate for breast cancer?

Recent findings shows an increased survival rate over previous reports that used newer classification methods. These observations may be partially explained by the use of chemotherapy for the TNBC group which may have resulted in earlier diagnosis of the tumor and detection of the disease at a later stage. These patients may have presented to a tertiary referral center for more intensive treatment. In our cohort, the use of adjuvant treatments did not reduce overall survival.

Anonymous Patient Answer

What is the latest research for breast cancer?

The most recent data indicate that the median survival from the time of diagnosis of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) to metastasis is 18 months, and the median overall and distant-free survival to last follow-up evaluation is 14.9 and 6.8 months, respectively. Also, in the past 10 years, the percentage of people presenting with a lump in the breast as part of their symptoms has probably increased. The most recent data show that breast cancer is one of the most common malignancies and it is estimated to be the fourth-most frequent cancer in women after lung cancer, colorectal cancer, and prostate cancer. There are approximately 40,000 cases of breast cancer diagnosed in the United States each year.

Anonymous Patient Answer

What are the chances of developing breast cancer?

This work does not provide a clear picture of the risk of breast cancer. It is not clear, either way, whether the difference in the risk among different ethnic groups is due to differences in genetics or other biological, social, and environmental factors. It is also important to mention that one’s ethnic background is not the only risk factor to consider and most individuals must do a combination of all these factors to increase their risk.\n

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Breast Cancer by sharing your contact details with the study coordinator.