CLINICAL TRIAL

Genetic Testing for Breast Cancer

1 Prior Treatment
Metastatic
Recurrent
Stage I
Waitlist Available · 18+ · Female · Houston, TX

This study is evaluating whether genetic testing can predict tumor response in patients with stage I-III HER2 negative invasive breast cancer.

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About the trial for Breast Cancer

Eligible Conditions
Invasive Breast Carcinoma · Anatomic Stage 1 Breast Cancer AJCC v8 · Breast Neoplasms · Anatomic Stage IB Breast Cancer AJCC v8 · Prognostic Stage IIIB Breast Cancer AJCC v8 · Anatomic Stage IV Breast Cancer AJCC v8 · Prognostic Stage IB Breast Cancer AJCC v8 · Anatomic Stage II Breast Cancer AJCC v8 · Prognostic Stage 2 Breast Cancer AJCC v8 · Prognostic Stage III Breast Cancer AJCC v8 · Anatomic Stage IIIB Breast Cancer AJCC v8 · Anatomic Stage IIA Breast Cancer AJCC v8 · Anatomic Stage IIIC Breast Cancer AJCC v8 · Prognostic Stage IIIC Breast Cancer AJCC v8 · Anatomic Stage III Breast Cancer AJCC v8 · Prognostic Stage IV Breast Cancer AJCC v8 · Anatomic Stage IIIA Breast Cancer AJCC v8 · Prognostic Stage IA Breast Cancer AJCC v8 · Prognostic Stage 1 Breast Cancer AJCC v8 · Prognostic Stage IIB Breast Cancer AJCC v8 · Prognostic Stage IIIA Breast Cancer AJCC v8 · Anatomic Stage IA Breast Cancer AJCC v8 · Prognostic Stage IIA Breast Cancer AJCC v8 · Anatomic Stage IIB Breast Cancer AJCC v8

Treatment Groups

This trial involves 2 different treatments. Genetic Testing 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Biopsy
PROCEDURE
Conventional Surgery
PROCEDURE
Genetic Testing
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 2
~1570
Conventional Surgery
2006
Completed Phase 3
~1000

Eligibility

This trial is for female patients aged 18 and older. You must have received 1 prior treatment for Breast Cancer or one of the other 23 conditions listed above. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The patient can undergo biopsy or surgery of a primary tumor site for suspected or proven invasive breast cancer of clinical stage I to III; stage IV patients will be allowed and included in the feasibility assessment, but will not be included in outcomes analysis for secondary objectives
The clinical or radiologic primary tumor size is at least 1 cm diameter
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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
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Time between diagnostic tumor biopsy and the first failure event, assessed at 3 and 5 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Time between diagnostic tumor biopsy and the first failure event, assessed at 3 and 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Time between diagnostic tumor biopsy and the first failure event, assessed at 3 and 5 years.
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 Genetic Testing will improve 1 primary outcome and 4 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of Up to 5 years.

Indeterminate Results
UP TO 5 YEARS
The study will use descriptive statistics to summarize the data in an effort to understand reasons for obtaining indeterminate results when trying to classify patients into 1 of the 4 subgroups (Groups A-D). Will summarize these data overall and separately for each biopsy method (e.g., fine needle aspiration, core needle biopsy, surgical resection).
UP TO 5 YEARS
Concordance of genomic analysis with immunohistochemistry (IHC)
UP TO 5 YEARS
The study will tabulate the estrogen receptor (ER) status and Her2 status of tumors as determined by the genomic analysis and by IHC. Will estimate the concordance between these 2 methods for ER status and for Her2 status with 95% confidence intervals.
UP TO 5 YEARS
Feasibility defined as the ability to classify patients into 1 of 4 cohorts
UP TO 5 YEARS
The study will use the methods of Thall et al. to monitor the ability to classify patients into 1 of 4 groups (success rate) throughout the trial. Will use summary statistics to describe the demographic and clinical characteristics of patients overall and within each subgroup (Groups A-D).
UP TO 5 YEARS
Frequency of tumors
UP TO 5 YEARS
The study will estimate the relative frequency of tumors classified within each prediction cohort (groups A-D) with 95% confidence intervals.
UP TO 5 YEARS
Disease-free survival (DFS)
TIME BETWEEN DIAGNOSTIC TUMOR BIOPSY AND THE FIRST FAILURE EVENT, ASSESSED AT 3 AND 5 YEARS
The study will estimate 3-year DFS with 95% confidence intervals within each subgroup (Groups A-D) using the Kaplan-Meier estimator. Will also use a Cox proportional hazards regression model to estimate the association between DFS and subgroup, genomic predictions of treatment response, treatment, age at diagnosis, tumor stage at diagnosis, clinical nodal status at diagnosis, and histologic grade.
TIME BETWEEN DIAGNOSTIC TUMOR BIOPSY AND THE FIRST FAILURE EVENT, ASSESSED AT 3 AND 5 YEARS

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?

These case-control studies provide information on potential environmental explanations for many aspects of breast cancer incidence. However, this information cannot be used to deduce the mechanism by which breast cancer occurs.

Anonymous Patient Answer

Can breast cancer be cured?

There is a very small chance that breast cancer may be cured. However, in those couples where both partners have had breast cancer and have survived long enough with no history of recurrence, the couple may actually develop and endure a life without breast cancer.

Anonymous Patient Answer

What is breast cancer?

Breast cancer is the main cancer that affects women in Europe and poses a major public health problem. This article presents information to the public for patients and clinicians concerning breast cancer.

Anonymous Patient Answer

What are common treatments for breast cancer?

There is no 'gold standard'. Some patients with breast cancer may be treated for only a short time with no effect, while others remain metastatic and have poorer outcomes despite new therapies. The timing and length of treatment has an important effect on a patient's outcome.

Anonymous Patient Answer

What are the signs of breast cancer?

Symptoms of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) mostly occur when the cancer has has metastasized. Breast cancer is often diagnosed by a physician only when its presence is suspected prior to or during a health check-up in which a mammogram is carried out. Symptoms of breast cancer include a lump or a lump and a painless mass in one breast. If there are symptoms or in a health check-up a physician should be alerted.\n

Anonymous Patient Answer

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

The American Cancer Society estimates 254,300 new diagnoses of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) will be made in 2022. At the same time, the number of new breast cancer cases in the United States may be about 1.2 million annually.

Anonymous Patient Answer

Is genetic testing typically used in combination with any other treatments?

The use of genetic testing is a relatively recent practice and is not yet common practice. The current practice of using genetic testing in combination with treatments may change as the potential benefits and cost become better understood. The potential benefits of improved prognostic information, response monitoring and treatment personalisation include: improving adherence to and adherence to treatment, reducing the need for invasive procedures and reducing costs. These outcomes are critical considerations when considering the value of genetic testing.

Anonymous Patient Answer

How quickly does breast cancer spread?

It is a common phenomenon that once tumour cells have migrated from primary tumour site to lymph node, it quickly spread to other tissues and then spread to primary tumour site. It takes on average one to two months for the metastasis of the primary tumour site to be felt.

Anonymous Patient Answer

Have there been any new discoveries for treating breast cancer?

The most recent studies have not added much (if any) to breast cancer surgery. On the contrary, some of the current new findings are harmful for patients. Current research has led to the development of new pharmaceuticals, but these can be harmful as well.

Anonymous Patient Answer

What are the common side effects of genetic testing?

The side effects of genetic testing vary by the type and location of the tests performed and by the individuals being tested. As test accuracy is improved, adverse effects may also evolve. A better understanding of what adverse experiences prospective patients are likely to encounter, particularly those who have had previous adverse experiences from earlier tests, may lead to greater satisfaction, and reduce concerns and risks.

Anonymous Patient Answer

Have there been other clinical trials involving genetic testing?

Patients with a family history of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) and other manifestations suggestive of hereditary syndromes may be investigated by clinical oncologists. Gene testing may confirm the existence of hereditary breast cancer in these patients. This genetic testing can identify at-risk individuals in order to obtain a more complete pedigree by inviting them--or their relatives--for testing. These tests have not been in routine clinical use, but may be helpful in a select number of cases for which it is appropriate. Genetic testing may be indicated for women with high grade breast cancer in whom clinical evaluation does not reveal any identifiable family history of breast or other cancers.

Anonymous Patient Answer

What is the primary cause of breast cancer?

Results from a recent clinical trial has demonstrated that the likelihood of breast cancer occurrence is significantly higher in some ethnic groups compared with others. Also it was found that the number of live births per female was higher in women with a family history of breast cancer, and this was independent of ethnicity.

Anonymous Patient Answer
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