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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether genetic testing can predict breast cancer tumors' response to standard treatments like chemotherapy or hormonal therapy. It focuses on patients with stage I-III HER2-negative invasive breast cancer to determine if certain tumor genes indicate sensitivity or resistance to these treatments. Participants will undergo a biopsy or surgery to collect tumor samples for genetic testing. The trial suits those with a primary tumor at least 1 cm in diameter who have not yet received any breast cancer treatment. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

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.

What prior data suggests that genetic testing is safe for predicting tumor response in breast cancer patients?

Research has shown that genetic testing for breast cancer, like the one in this trial, is generally safe. These tests examine tumor samples to determine if certain genes are active, which can help predict how tumors might respond to treatments.

Previous studies have demonstrated that genetic testing does not harm individuals. It involves a biopsy, a standard procedure to take a small piece of tissue for testing. No reports of serious side effects have been specifically linked to the genetic testing process itself.

While this trial is in an early stage, some evidence indicates safety, but more research is needed to fully confirm it. For those considering joining a trial, genetic testing is usually well-tolerated and does not pose significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about genetic testing for breast cancer response prediction because it offers a personalized approach to treatment. Unlike traditional methods that often apply a one-size-fits-all strategy, this technique uses genetic information from a patient's tumor to tailor treatment plans. This personalized strategy aims to improve treatment effectiveness and reduce unnecessary side effects by closely aligning therapies with the patient’s unique genetic makeup. Such a targeted approach could lead to better outcomes and a more efficient use of medical resources.

What evidence suggests that genetic testing is effective for predicting tumor response in breast cancer?

Research shows that genetic testing, which participants in this trial will undergo, can help predict how breast cancer tumors respond to treatment. Studies have found that testing for specific genetic markers indicates whether a tumor might be sensitive or resistant to treatments like chemotherapy or hormone therapy. One study discovered that genetic tests effectively assess certain tumor traits, aiding doctors in customizing treatments more accurately. Additionally, understanding a person's genetic makeup, such as their HRD status, predicts how well they might respond to certain cancer drugs, like those used in chemotherapy. Overall, genetic testing provides valuable insights that guide treatment decisions for breast cancer patients. ^{2 4 6 7 8}

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

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10706486/

Genetic Testing Enhances the Precision Diagnosis and ... Genetic testing of ctDNA effectively evaluates the TMB and molecular characteristics of advanced breast cancer and has certain clinical value ...

2. nature.com nature.com/articles/d42473-025-00336-y

Increasing genetic testing for breast cancer genes “An individual's HRD status can predict a tumour's response to therapies — such as platinum-based chemotherapy and PARP inhibitors — that are particularly ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12256763/

Recent Insights Into Breast Cancer: Molecular Pathways ... This review presents recent advances in breast cancer research, with a particular emphasis on molecular and epigenetic mechanisms that contribute to tumor ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0960977625000426

Comprehensive genomic profiling can predict response to ... This study suggests that comprehensive CDx testing can be explored as a prognostic tool in early-stage TNBC to predict responses to NACT and disease ...

5. cancer.gov cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet

BRCA Gene Changes: Cancer Risk and Genetic Testing The risks of developing breast and ovarian cancer are markedly increased in people who inherit a harmful change in BRCA1 or BRCA2.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4998965/

Genetic tests to identify risk for breast cancer - PMC This article provides oncology nurses and APNs with an overview of genetic tests for hereditary mutations that may increase a patient's personal risk of breast ...

7. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)47403-6/fulltext

Decisions and outcomes of genetic testing for inherited ... This article explores findings related to genetic test acceptance for inherited breast cancer risk and the impact of genetic test results on psychological ...

8. cancer.gov cancer.gov/about-cancer/causes-prevention/genetics/genetic-testing-fact-sheet

Genetic Testing Fact Sheet - NCI A fact sheet about genetic testing for inherited cancer risk. Includes who should consider testing, and how to understand test results.