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A Phase 1B Trial Evaluating the Safety of Ribociclib, Tucatinib, and Trastuzumab in Patients With Metastatic, HER2+ Breast Cancer and a Multicenter, Randomized, Open-Label, Phase 2 Study of Preoperative Treatment With Ribociclib,Ttrastuzumab, Tucatinib, and Fulvestrant Versus Docetaxel, Carboplatin,Ttrastuzumab, and Pertuzumab in HR+/HER2+ Breast Cancer and Ribociclib, Trastuzumab, and Tucatinib Versus Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab in Patients With HR-/HER2+ Breast Cancer

NCT05319873 is registered in ClinicalTrials.gov with Jonsson Comprehensive Cancer Center as lead sponsor.

NCT NCT05319873
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase 1B Trial Evaluating the Safety of Ribociclib, Tucatinib, and Trastuzumab in Patients With Metastatic, HER2+ Breast Cancer and a Multicenter, Randomized, Open-Label, Phase 2 Study of Preoperative Treatment With Ribociclib,Ttrastuzumab, Tucatinib, and Fulvestrant Versus Docetaxel, Carboplatin,Ttrastuzumab, and Pertuzumab in HR+/HER2+ Breast Cancer and Ribociclib, Trastuzumab, and Tucatinib Versus Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab in Patients With HR-/HER2+ Breast Cancer
Lead sponsor
Jonsson Comprehensive Cancer Center
Phase
Phase 1/2
Overall status
Active, not recruiting
Start date
April 7, 2022
Completion date
April 1, 2028
Enrollment
18 (estimated)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

anatomic stage ii breast cancer ajcc v8, anatomic stage iia breast cancer ajcc v8, anatomic stage iib breast cancer ajcc v8, anatomic stage iii breast cancer ajcc v8, anatomic stage iiia breast cancer ajcc v8, anatomic stage iiib breast cancer ajcc v8, anatomic stage iiic breast cancer ajcc v8, anatomic stage iv breast cancer ajcc v8, invasive breast carcinoma, locally advanced her2-positive breast carcinoma, metastatic her2-positive breast carcinoma, prognostic stage ib breast cancer ajcc v8, prognostic stage ii breast cancer ajcc v8, prognostic stage iia breast cancer ajcc v8, prognostic stage iib breast cancer ajcc v8, prognostic stage iii breast cancer ajcc v8, prognostic stage iiia breast cancer ajcc v8, prognostic stage iiib breast cancer ajcc v8, prognostic stage iiic breast cancer ajcc v8, prognostic stage iv breast cancer ajcc v8