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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-line Gemcitabine Plus Cisplatin in Locally Advanced (IIIC Stage) Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06531447
- Acronym / sponsor ID
- MOM-0004
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, TUBB3 gene, ERCC1 gene, RMM1 gene, Prognosis and predictive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The National Center of Oncology, AzerbaijanOther government
- Study start
- May 2014
- Primary completion
- Nov 2017 (actual)
- Study completion
- May 2027 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the study is to investigate of the prognostics and predictive role of TUBB3 expression in locally advanced breast cancer
Detailed description
Using combination of gemcitabine plus cisplatine as first line treatment patients with locally advanced breast cancer with high TUBB3 expression
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Doxorubicin, Drug: Cyclophosphamide, Drug: PaclitaxelDoxorubicin 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. |
| Experimental group | Active comparator | Drug: Cisplatin, Drug: Gemcitabine1250 mg/m2 Gemcitabine 1st and 8th days of 6 cycles and 75mg/m2 Cisplatine 1st day every 3 weeks of 6 cycles |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- IIIC stage breast cancer patients
Key exclusion criteria (1 listed)
- Other stages breast cancer patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CisplatinAlso: CDDPEvery 21 days 6 cycles | Drug | Experimental group |
| GemcitabineAlso: Gemcitabine hydrochloridEvery 21 days (First and 8th days) 6 cycles | Drug | Experimental group |
| DoxorubicinEvery 21 days 4 cycles | Drug | Control group |
| CyclophosphamideEvery 21 days 4 cycles | Drug | Control group |
| PaclitaxelEvery 21 days 4 cycles or once a week for 12 weeks | Drug | Control group |
Primary outcome
Clinical tumor regression rate
Time frame: 4 months
Chemotherapy combination Gemcitabine with Cisplatin
1 secondary outcome
Increasing PFS and OS
Time frame: 5 years and 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elchin Mansurov, PhD principal investigator
The National Center of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Azerbaijan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical tumor regression rate (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.