Genetic Testing for Breast Cancer Response Prediction

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: HER2-positive, Prior cancer, Prior therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

1100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase II trial studies how well genetic testing works in predicting tumor response in patients with stage I-III HER2 negative invasive breast cancer. Genetic testing is a procedure that tests tumor samples to learn if certain genes are activated (turned on) in the tumor and if the activation of these genes may predict if the tumor will be sensitive or resistant to routine breast cancer treatments, such as chemotherapy or hormonal therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is genetic testing for breast cancer generally safe for humans?

Genetic testing for breast cancer, such as BRCA1 and BRCA2 testing, is generally considered safe for humans. It involves analyzing genes to assess cancer risk and does not involve any physical intervention that could cause harm. ^{1 2 3 4 5}

How does genetic testing for breast cancer response prediction differ from other treatments?

This treatment is unique because it uses genetic testing to predict how a person with breast cancer might respond to different treatments, allowing for more personalized and potentially effective treatment plans. Unlike standard treatments that are generally applied to all patients, this approach tailors the treatment based on individual genetic information. ^{6 7 8 9 10}

What data supports the effectiveness of genetic testing as a treatment for breast cancer response prediction?

Genetic testing helps personalize breast cancer treatment by identifying specific genetic mutations, which can guide doctors in choosing the most effective therapies and assessing cancer recurrence risk. It has been shown to improve treatment decisions and outcomes by tailoring strategies to individual genetic profiles, as seen with the use of BRCA1/2 testing and other high-risk genes. ^{5 11 12 13 14}

Who Is on the Research Team?

Senthilkumar Damodaran

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with stage I-III HER2 negative invasive breast cancer, who have a tumor at least 1 cm in diameter and can undergo biopsy or surgery. It's not for those who had prior breast cancer treatments, other cancers within the last 5 years (except certain skin cancers), or tumors obscured by hematoma/biopsy changes.

Inclusion Criteria

You can have a biopsy or surgery for suspected or confirmed invasive breast cancer in its early to advanced stages. If you have stage IV cancer, you can take part in the study to see if the treatment works, but your results won't be included in some of the analysis.

The main tumor is at least 1 cm in size based on clinical or radiologic measurements.

Exclusion Criteria

You had surgery to remove the main breast cancer before.

You have breast cancer with a specific genetic change called HER2-positive.

You have already received medication or radiation treatment for breast cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic

Patients undergo biopsy or surgery to obtain tumor sample for genetic testing

1-2 weeks

1 visit (in-person)

Treatment Assignment

Patients are assigned to 4 treatment cohorts as determined by genetic test results

Varies based on cohort

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Genetic Testing

Trial Overview The study is testing if genetic testing on tumor samples can predict how well these tumors will respond to standard breast cancer treatments like chemotherapy or hormonal therapy. This could help tailor treatment plans to individual patients.

How Is the Trial Designed?

Group I: Diagnostic (biopsy, surgery, genetic testing) Experimental Treatment 3 Interventions

Patients undergo biopsy or surgery to obtain tumor sample for genetic testing. Patients are then assigned to 4 treatment cohorts as determined by genetic test results.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Genetic testing in breast cancer treatment helps personalize care by providing crucial information for both germline and tumor testing, which aids in risk evaluation and treatment options.

Discussions about hereditary cancer genetic testing should cover potential results, management strategies, and concerns about privacy and discrimination, highlighting the role of genetic professionals in supporting patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cases in Precision Medicine: The Role of Tumor and Germline Genetic Testing in Breast Cancer Management. Tischler, J., Crew, KD., Chung, WK.[2020]

A survey of 80 genetic counselors revealed that 96% recommend confirmatory clinical-grade testing for patients with positive direct-to-consumer genetic test results for BRCA1/2 variants, indicating a strong consensus on the need for verification of these results.

However, there is significant variability in the specific types of confirmatory tests recommended, with options ranging from single-site analysis to multi-gene panel testing, highlighting the need for clearer guidelines in genetic counseling practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic counselor approaches to BRCA1/2 direct-to-consumer genetic testing results. Burke, S., Mork, M., Qualmann, K., et al.[2021]

Genetic testing for cancer-related mutations is becoming more accessible in general healthcare, moving beyond specialized genetic services.

Surgeons play a crucial role in identifying patients who may benefit from genetic testing and can adjust their treatment plans based on the test results, enhancing personalized cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic testing for cancer susceptibility. Calzone, KA., Soballe, PW.[2018]

There is a growing demand for breast cancer risk assessment due to increased awareness of genetic factors, highlighting the need for effective communication methods for conveying complex genetic information to consumers and their families.

Research is needed to evaluate the psychosocial and behavioral outcomes of web- and telephone-based genetic services, especially regarding how to communicate risks to at-risk relatives, including minors, to ensure effective risk management and support for those affected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controversies in communication of genetic risk for hereditary breast cancer. Mackenzie, A., Patrick-Miller, L., Bradbury, AR.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Cases in Precision Medicine: The Role of Tumor and Germline Genetic Testing in Breast Cancer Management. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Molecular Genomic Testing for Breast Cancer: Utility for Surgeons. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Genetic counselling and testing of susceptibility genes for therapeutic decision-making in breast cancer-an European consensus statement and expert recommendations. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Paired tumor sequencing and germline testing in breast cancer management: An experience of a single academic center. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

The validation and clinical implementation of BRCAplus: a comprehensive high-risk breast cancer diagnostic assay. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

The breast surgeon's role in BRCA1 and BRCA2 testing. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Genetic counselor approaches to BRCA1/2 direct-to-consumer genetic testing results. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Genetic testing for cancer susceptibility. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Controversies in communication of genetic risk for hereditary breast cancer. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Genetic tests to identify risk for breast cancer. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Genetics of Breast Cancer: Risk Models, Who to Test, and Management Options. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Breast Cancer Risk Genes - Association Analysis in More than 113,000 Women. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Interest in genetic testing for modest changes in breast cancer risk: implications for SNP testing. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Guidelines for genetic risk assessment of hereditary breast and ovarian cancer: early disagreements and low utilization. [2021]