Active Trials

Breast Cancer

Preoperative THP and postoperative HP in Patients who achieve a pathologic complete response

Summary:

This non-randomized Phase II trial is for patients who have been diagnosed with a type of breast cancer known as HER2-positive. The patient must not have yet received any treatment for this cancer. The purpose of the study is to test whether it is safe to eliminate additional chemotherapy in patients with HER2-positive breast cancer who have no remaining cancer at surgery after receiving a single dose chemotherapy drug with Trastuzumab and Pertuzumab for 12 weeks before surgery. This study will allow researchers to know whether this treatment approach may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual approach.

For more information: https://clinicaltrials.gov/ct2/show/NCT04266249

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 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

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

A Master Protocol to Evaluate Biomarker-Driven Therapies and Immunotherapies in Previously Treated Non-Small Cell Lung Cancer (Lung-MAP Screening Study)

Summary:

This screening study is for patients who have been diagnosed with non-small cell lung cancer. The patient will be asked to submit their tumor sample to test for specific genes and proteins. Based on the test results, the patient may be assigned to a treatment sub study. This will take place if and when the patient progresses.

For More Information: https://clinicaltrials.gov/ct2/show/NCT03851445?term=lungmap&draw=2&rank=1

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

This trial is for patients with non-squamous non-small cell lung cancer who have progressed. The usual treatment approach for patients being treated for second-line non-small cell lung cancer is treatment with chemotherapy. The purpose of this study is to compare the two investigational treatments Cabozantinib alone to using Cabozantinib plus the usual treatment Nivolumab to the current standard of care second line therapy. This study will help researchers know if either treatment with Cabozantinib or treatment with Cabozantinib plus Nivolumab is better, or the same as the standard chemotherapy approach.

For more information: https://clinicaltrials.gov/ct2/show/NCT04310007

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