A Phase 2 interventional study of Cisplatin and Gemcitabine in Breast Cancer, sponsored by The National Center of Oncology, Azerbaijan. Active, not recruiting at 1 site in Azerbaijan. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-08-01.
Sponsored by The National Center of Oncology, Azerbaijan · Phase 2, Interventional, and Treatment
The goal of the study is to investigate of the prognostics and predictive role of TUBB3 expression in locally advanced breast cancer
Using combination of gemcitabine plus cisplatine as first line treatment patients with locally advanced breast cancer with high TUBB3 expression
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 200 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →The National Center of Oncology, Azerbaijan is the lead sponsor of 4 studies on the registry; none are open to participants now.
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IIIC stage breast cancer patients
Exclusion Criteria:
Other stages breast cancer patients
Doxorubicin 60mg/m2(Adriblastin) plus Cyclophosphamide 600mg/m2 (endoxan) IV, on 1st days every 3 weeks of 4 cycles. Paclitaxel (Taxol) 80mg/m2, IV every week of 12 cycles or 175mg/m2, IV, on 1st days every 3 weeks of 4 cycles.
Drug: Doxorubicin · Drug: Cyclophosphamide · Drug: Paclitaxel
1250 mg/m2 Gemcitabine 1st and 8th days of 6 cycles and 75mg/m2 Cisplatine 1st day every 3 weeks of 6 cycles
Drug: Cisplatin · Drug: Gemcitabine
Every 21 days 6 cycles
Also known as: CDDP
Every 21 days (First and 8th days) 6 cycles
Also known as: Gemcitabine hydrochlorid
Every 21 days 4 cycles
Every 21 days 4 cycles
Every 21 days 4 cycles or once a week for 12 weeks
Clinical tumor regression rate
Chemotherapy combination Gemcitabine with Cisplatin
Time frame: 4 months
Increasing PFS and OS
Observation after chemotherapy
Time frame: 5 years and 10 years
Plan to share: Yes
Supporting information: Study protocol
Time frame: Available from 2022
Access criteria: Breast cancer specialists
No publications or documents are linked to this record.
The record gives a start of May 2014, a primary completion of Nov 2017 and a completion of May 2027. It does not say whether these dates are actual or estimated.
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This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Cisplatin · Gemcitabine
The National Center of Oncology, Azerbaijan