Category: Breast Cancer

NCT#:	NCT05929768
NCT QR Code
Title:	Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study
Protocol:	S2212
Cancer Type	Breast
Study Sponsor:	SWOG Cancer Research Network
Brief Summary:	This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage triple negative breast cancer. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell’s deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body’s immune response. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Doxorubicin is an anthracycline chemotherapy drug that damages DNA and may kill cancer cells. Pembrolizumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Shorter treatment without anthracycline chemotherapy may work the same as the usual anthracycline chemotherapy treatment for early-stage triple negative breast cancer.
Study Type:	Interventional
Date Opened at SVH:	February 7, 2024
Recruitment Status:	Recruiting
Study Population:
Eligibility Criteria:	See SCHEMA
Principal Investigator:	Geetha N. Varma, MD, Oncology, Salinas Valley Health Cancer Care, (831) 755-1701
Participating Institution:	Salinas Valley Health
Salinas Valley Health Clinical Research Program:	Terri Nielsen, MSJ, RN, CCRP, Clinical Research Program Manager, [email protected]
Link to ClinicalTrials.gov	https://classic.clinicaltrials.gov/ct2/show/NCT05812807?term=NCT05812807&draw=2&rank=1
Summary	Summary

NCT#:	NCT05812807
NCT QR Code
Title:	OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy
Protocol:	A012103
Cancer Type	Breast
Study Sponsor:	Alliance/NCI
Brief Summary:	The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.
Study Type:	Interventional
Date Opened at SVH:	August 3, 2023
Recruitment Status:	Recruiting
Study Population:
Eligibility Criteria:	See SCHEMA
Principal Investigator:	Geetha N. Varma, MD, Oncology, Salinas Valley Health Cancer Care, (831) 755-1701
Participating Institution:	Salinas Valley Health
Salinas Valley Health Clinical Research Program:	Terri Nielsen, MSJ, RN, CCRP, Clinical Research Program Manager, [email protected]
Link to ClinicalTrials.gov	https://classic.clinicaltrials.gov/ct2/show/NCT05812807?term=NCT05812807&draw=2&rank=1
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NCT#:	NCT03488693
NCT QR Code
Title:	Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer (TAILOR RT)
Protocol:	CCTG MA.39
Cancer Type:	Breast
Study Sponsor:	Canadian Cancer Trials Group NCI CIRB
Brief Summary:	The purpose of this study is to compare the effects on low risk breast cancer receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back.
Study Type:	Interventional
Date Opened at SVH:	May 6, 2022
Recruitment Status:	Recruiting
Study Population:
Eligibility Criteria:	See SCHEMA
Principal Investigator:	Jacob Andrade MD PhD, Coastal Radiation Oncology Salinas, (831) 758-2724
Participating Institution:	Salinas Valley Health
SVH Clinical Research Program:	Terri Nielsen, MSJ, RN, CCRP, Clinical Research Program Manager, [email protected]
Link to ClinicaTrials.gov	https://clinicaltrials.gov/ct2/show/record/NCT03488693?term=CCTG+MA.3&draw=2&rank=1
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NCT#	NCT04457596
NCT QR Code
Title:	T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial
Protocol:	A011801
Cancer Type:	Breast
Study Sponsor:	NCI /Alliance
Brief 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.
Study Type:	Interventional
Date Opened at SVH:	4-Jan-2022
Recruitment Status:	Recruiting
Study Population:
Eligibility Criteria:	See SCHEMA
Principal Investigator:	Hong Zhao, MD, Oncology, Salinas Valley Health Cancer Care, (831) 755-1701
Participating Institution:	Salinas Valley Health
SVH Clinical Research Program:	Terri Nielsen, MSJ, RN, CCRP, Clinical Research Program Manager,  [email protected]
Link to ClinicalTrials.gov:	https://clinicaltrials.gov/ct2/show/record/NCT04457596?term=A011801&draw=2&rank=1
Schema & Protocol	A011801-Schema