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New Breast Cancer Clinical Trials

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ASPRIA: Atezolizumab with sacituzumab govitecan to prevent recurrence in triple negative breast cancer (Trial #20-028, NCT04434040)

Trial description:
This study is evaluating combination therapy with sacituzumab govitecan and atezolizumab in patients with residual triple negative breast cancer in the breast or lymph nodes after preoperative chemotherapy, and with detectable circulating tumor DNA (ctDNA) after completion of local therapy. Patients who test ctDNA-positive can receive 18 weeks of adjuvant sacituzumab and atezolizumab as an alternative to capecitabine.

Eligibility requirements:
Pathologically confirmed residual invasive breast cancer in the breast and/or lymph node(s), with detectable ctDNA on a research prescreening assessment, following neoadjuvant chemotherapy for triple negative breast cancer. In the absence of residual invasive disease in the breast, lymph node must contain at least 2mm of invasive disease. ctDNA testing should occur after completion of local therapy, but before starting capecitabine. 


 

TBCRC 056: Preoperative niraparib with dostarlimab for BRCA- or PALB2-mutated breast cancer (Trial #20-371, NCT04584255)

Trial description:
This research study offers 18 weeks of preoperative systemic therapy with combination niraparib (PARP inhibitor) and dostarlimab (anti PD-1 monoclonal antibody) for triple-negative or HR+/HER2- breast cancer in individuals with BRCA1/2 and/or PALB2 mutations.

Eligibility requirements:
Participants must have stage I-III invasive breast cancer with primary tumor size at least 1.5 cm, and a documented mutation in BRCA1, BRCA2, or PALB2. All tumors must be HER2-negative.


 

SERENA-6: Switching to oral SERD camizestrant + CDK4/6 inhibitor vs continuing aromatase inhibitor + CDK4/6 inhibitor in HR+/HER2- metastatic breast cancer patients who develop an ESR1 mutation (Trial #21-518, NCT04964934)

Trial description:
This study has two steps. Step 1 enrolls patients with HR+/HER2- metastatic breast cancer who have been stable on first-line aromatase inhibitor (AI) and CDK4/6 inhibitor for at least 6 months, and are then followed with serial ctDNA. If an ESR1 mutation is detected, patients may enroll in Step 2, which randomizes to camizestrant, an oral SERD, with CDK4/6 inhibitor versus AI with CDK4/6 inhibitor.

Eligibility requirements:
Eligible patients for Step 1 have metastatic HR+/HER2- breast cancer, currently on AI (letrozole or anastrozole) + CDK4/6 inhibitor (palbociclib or abemaciclib) ± LHRH as the initial endocrine-based treatment for advanced disease, with disease stability for at least 6 months, and evaluable disease. Patients become eligible for Step 2 if found to have an ESR1 mutation detected by central ctDNA testing performed in Step 1. 


 

PI3 kinase inhibitor GDC-0084 and trastuzumab for HER2+ brain metastases (Trial #18-516, NCT03765983)

Trial description:
This research study is evaluating the PI3 kinase inhibitor GDC-0084 in combination with trastuzumab (Herceptin®) as treatment for HER2-positive breast cancer with brain metastases.

Eligibility requirements:
HER2+ metastatic breast cancer with brain metastases that are new/untreated or progressing after local therapy. 


 

Abemaciclib in combination with endocrine therapy in patients age 70+ with ER+ metastatic breast cancer who have previously received a CDK4/6 inhibitor (Trial #21-707, NCT04305834)

Trial description:
This trial studies the tolerability of abemaciclib in combination with endocrine therapy in patients age 70 years and older with metastatic HR+/HER2- breast cancer who were previously treated with a different CDK4/6 inhibitor.


Eligibility requirements:
Eligible patients are >70 years old with metastatic HR+/HER2- breast cancer and prior progression on palbociclib or ribociclib.