Breast CancerPhase 2NCT06531447
First-line Gemcitabine Plus Cisplatin in Locally Advanced (IIIC Stage) Breast Cancer Patients
A Phase 2 study testing Cisplatin, Gemcitabine and Doxorubicin in people with Breast Cancer, run by The National Center of Oncology, Azerbaijan at 1 site in Azerbaijan.
Trial summary
The goal of the study is to investigate of the prognostics and predictive role of TUBB3 expression in locally advanced breast cancer Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cisplatin, Gemcitabine and Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteAzerbaijan
- Study dates
- May 2014to May 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IIIC stage breast cancer patients
Who cannot join
- Other stages breast cancer patients
Trial locations and contacts
1 site in 1 country.
About this study
The goal of the study is to investigate of the prognostics and predictive role of TUBB3 expression in locally advanced breast cancer
Read the detailed description
Using combination of gemcitabine plus cisplatine as first line treatment patients with locally advanced breast cancer with high TUBB3 expression
- Conditions
- Breast Cancer
- Being tested
- Cisplatin, Gemcitabine, Doxorubicin, Cyclophosphamide, Paclitaxel
- Keywords
- Breast cancer, TUBB3 gene, ERCC1 gene, RMM1 gene, Prognosis and predictive
- Medical subject headings
- Breast Neoplasms, Fibrosis Of Extraocular Muscles, Congenital, 3A, with or without Extraocular Involvement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Also called CDDP
Every 21 days 6 cycles
GemcitabineDrug
Also called Gemcitabine hydrochlorid
Every 21 days (First and 8th days) 6 cycles
DoxorubicinDrug
Every 21 days 4 cycles
CyclophosphamideDrug
Every 21 days 4 cycles
PaclitaxelDrug
Every 21 days 4 cycles or once a week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | 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. Receives: Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Paclitaxel |
| Experimental group | Active comparator | 1250 mg/m2 Gemcitabine 1st and 8th days of 6 cycles and 75mg/m2 Cisplatine 1st day every 3 weeks of 6 cycles Receives: Drug: Cisplatin; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical tumor regression rate
Chemotherapy combination Gemcitabine with Cisplatin
Measured: 4 months
Secondary outcomes (1)
Increasing PFS and OS
Observation after chemotherapy
Measured: 5 years and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study startMay 2014
- Primary completionNov 2017
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The National Center of Oncology, Azerbaijan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Elchin Mansurov, The National Center of Oncology, Azerbaijan
- Investigators
- Elchin Mansurov, PhD, Principal investigator, The National Center of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531447
- Sponsor's protocol ID
- MOM-0004
- Status last verified
- Apr 2024
- First submitted
- 8 Apr 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes