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Breast Cancer

A Randomized Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with >/= 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy

Summary:

This randomized Phase III trial is for patients who have been diagnosed with “triple-negative” breast cancer. Triple negative means that this type of cancer does not have receptors for estrogen, progesterone, or the protein HER2 that may be found in other breast cancers. The patient must have had preoperative chemotherapy that the breast cancer has at least partially survived. The current standard of care may include no more treatment after surgery or the doctor may recommend further chemotherapy or radiation.

This study compares the usual approach (no treatment or additional treatment as recommended by your doctor) and one year of the experimental drug MK-3475 (also called pembrolizumab). This study will allow researchers to know whether treatment with MK-3475 is better, the same, or worse than the usual approach alone.

For More Information: https://clinicaltrials.gov/ct2/show/NCT02954874?term=s1418&draw=2&rank=1

A Randomized, Double-Blind, Phase III Trial of Paclitaxel/ Trastuzumab/ Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer

Summary:

This Phase III trial is for patients who have HER2-positive metastatic breast cancer. The usual approach to this cancer is chemotherapy combined with trastuzumab and pertuzumab. This trial compares the usual treatment and placebo versus the usual treatment and atezolizumab. Atezolizumab is already approved by the FDA for use in non-small cell lung and urinary cancer. The use in this study is considered experimental. This trial is double-blinded, meaning that neither the patient nor the health care team will know which treatment you will be receiving.

For More Information: https://clinicaltrials.gov/ct2/show/NCT03199885?term=br004&draw=2&rank=2

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

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

Lung Cancer

Lung Cancer In Older Adults: Treatment Toxicity Through the Patient’s Lens

Summary:

This study is for patients who are 65 years or older, have lung cancer and will be starting a new treatment. The purpose of this study is to learn more about how older adults tolerate lung cancer treatment and how treatment affects their daily lives.

For More Information: http://cancer.ucsf.edu/support/older-adult/research

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 substudy. 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

A Randomized Phase II Trial of Cabozantinib and Cabozantinib plus Nivolumab versus Standard Chemotherapy in Patients with Previously Treated Non-Squamous NSCLC

Summary:

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 standardard chemotherapy approach.

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

Colorectal Cancer

Duloxetine to Prevent Oxaliplatin-Induced Chemotherapy Induced Peripheral Neuropathy: A Randomized Double Blind, Placebo Controlled Phase II to Phase III Study

Summary:

This study is for patients who have been diagnosed with stage II – III colorectal cancer and are starting a cancer treatment with Oxaliplatin. The trial studies the best dose of duloxetine and how well it works in preventing pain, tingling, and numbness (peripheral neuropathy) caused by treatment with Oxaliplatin. There are no known treatment to prevent Oxaliplatin induced peripheral neuropathy. Giving duloxetine in patients undergoing treatment with Oxaliplatin for colorectal cancer may help prevent peripheral neuropathy.

For more information: https://clinicaltrials.gov/ct2/show/NCT04137107

GO: Gut Microbiome and Oral Fluoropyrimidine Study in Patients with Colorectal Cancer

Summary:

This purpose of this study is to investigate the alterations in the gut microbiome that occur during the course of treatment for colorectal cancer (CRC).

For More Information: https://clinicaltrials.ucsf.edu/trial/NCT04054908

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

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