Active Trials

Breast Cancer

The COMPASSHER2 Trials (Comprehensive Use of Pathologic Response Assessment to Optimize Therapy in HER2-Positive Breast Cancer): COMPASSHER2 Residual Disease (RD), A Double- Blinded, Phase III Randomized Trial of T-DM1 and Placebo Compered with T-DM1 and Tucatinib

Summary:

This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.

For more information: https://clinicaltrials.gov/study/NCT04457596

A Study of Imlunestrant versus Standard Endocrine Therapy in Participants with Early Breast Cancer (EMBER-4)

Summary:

The main purpose of this study is to measure how well Imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.

For more information: https://clinicaltrials.gov/study/NCT05514054

A Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER2-Negative, Oncotype Recurrence Score ≤ 18 Breast Cancer

Summary:

This study is for patients age 50-70, who have been diagnosed with early stage breast cancer who have had breast-conserving surgery also known as lumpectomy, with an Oncotype Recurrence Score equal to or less than 18 and is sensitive to hormones. The study compares the usual approach after lumpectomy to the use of hormonal drugs alone. This study will allow researchers to know whether treatment with hormonal drugs alone is better, the same or worse than the usual approach.

For more information: https://clinicaltrials.gov/ct2/show/NCT04852887

Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors: A Multi-Center Randomized Double-Blinded Controlled Trial

Summary:

This goal of this trial is to determine the efficacy of advanced cognitive training for cancer survivors suffering from cancer and cancer-treatment-related cognitive dysfunction.

For more information: https://clinicaltrials.gov/study/NCT05896189?term=NRG-CC011&rank=1

Colon Cancer

Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-US)

Summary:

This phase II/III study is for patients with stage III and high risk stage II colon cancer. The study will be seeking to determine whether chemotherapy is needed for all or only some patients in this population, and, if chemotherapy is needed, what kind of chemotherapy to recommend to patients based on the presence or absence of circulating tumor DNA (ctDNA) following surgery for colon cancer.

For more information: https://clinicaltrials.gov/study/NCT05174169

Lung Cancer

Randomized Phase III Study of Combination Osimertinib (AZD9291) and Bevacizumab versus Osimertinib (AZD9291) Alone as First-Line Treatment for Patients with Metastatic EGFR- Mutant Non-Small Cell Lung Cancer (NSCLC)

Summary:

A phase III study for patients who have been diagnosed with non-small lung cancer that has spread outside of the lungs and has a change in a gene called EGFR. The study compares the usual treatment approach of osimertinib alone to using bevacizumab plus osimertinib. This study will help researchers know whether this new approach of bevacizumab plus osimertinib is better, the same or worse than the usual approach.

For More Information: https://clinicaltrials.gov/ct2/show/NCT04181060

Prostate Cancer

Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic risk with Radiation

Summary:

A phase III trial for patients who have been diagnosed with high-risk prostate cancer. The study uses the Decipher risk score to decide if patients are assigned to the part of the study comparing a more aggressive treatment with the usual treatment for high Decipher risk score prostate cancer or assigned to the part of the study comparing a less aggressive treatment to the usual treatment for low Decipher score prostate cancer.

For more information: https://clinicaltrials.gov/ct2/show/NCT04513717

Parallel Phase III Randomized Trials of Genomic Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation

Summary:

A phase III trial uses the Decipher risk score to guide intensification or de-intensification of treatment to better match therapies to an individual patient’s cancer aggressiveness. The Decipher Risk score evaluates a prostate cancer for its potential to spread.

In patient with low gene risk scores, the trial compares radiation therapy alone to the usual treatment of radiation therapy and hormone therapy. Giving radiation treatment alone may be the same as the usual approach for controlling the cancer and preventing it from spreading, while avoiding the side effects with hormonal therapy. Additionally, researchers want to know if adding another new hormone therapy drug to the usual combination of radiation and hormone therapy increases the length of time without prostate cancer spreading for men with a higher gene risk score.

For more information: https://clinicaltrials.gov/study/NCT05050084?term=NRG-GU010&rank=1