Gemcitabine, Doxorubicin and Paclitaxel (GAT) as Neoadjuvant Treatment of Breast Cancer Patients
Phase II Pharmacogenomic and Clinical Trial for the Administration of Gemcitabine-doxorubicin-paclitaxel (GAT) as Neoadjuvant Treatment of Patients With Stage III Breast Cancer
Sponsor: Bristol-Myers Squibb
This PHASE2 trial investigates Breast Cancer and is currently completed. Bristol-Myers Squibb leads this study, which shows 9 recorded versions since 2003 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)2 treatment cycles of chemotherapy (one cycle = 2 weeks) must be administered to each patient before breast surgery.
The required number of patients has been calculated following Simon's method. 43 patients will be enrolled in two phases: first, 29 patients must be enrolled, and at least 2 pathological complete responses obtained. Patients recruitment will continue until 43 patients have been enrolled. Assumptions are that there is a 95% probability to obtain a rate of pathological complete responses of at least 10%.
2 treatment cycles of chemotherapy (one cycle = 2 weeks) must be administered to each patient before breast surgery.
The required number of patients has been calculated following Simon's method. 43 patients will be enrolled in two phases: first, 29 patients must be enrolled, and at least 2 pathological complete responses obtained. Patients recruitment will continue until 43 patients have been enrolled. Assumptions are that there is a 95% probability to obtain a rate of pathological complete responses of at least 10%.
Status Flow
Change History
9 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE2
-
Sep 2024 — Present [monthly]
Completed PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
-
Apr 2023 — Jul 2024 [monthly]
Completed PHASE2
-
Jan 2021 — Apr 2023 [monthly]
Completed PHASE2
▶ Show 4 earlier versions
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Jan 2019 — Jan 2021 [monthly]
Completed PHASE2
-
Jun 2018 — Jan 2019 [monthly]
Completed PHASE2
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Apr 2018 — Jun 2018 [monthly]
Completed PHASE2
-
Jan 2017 — Apr 2018 [monthly]
Completed PHASE2
First recorded
Mar 2003
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Bristol-Myers Squibb
- Eli Lilly and Company
- Spanish Breast Cancer Research Group
For direct contact, visit the study record on ClinicalTrials.gov .