Breast CancerPhase 2NCT00128856
Gemcitabine, Doxorubicin and Paclitaxel (GAT) as Neoadjuvant Treatment of Breast Cancer Patients
A Phase 2 study testing Gemcitabine, Adriamycine and Paclitaxel in people with Breast Cancer, run by Spanish Breast Cancer Research Group at 10 sites in Spain.
Trial summary
This is a multicenter, open-label, phase II trial to assess the efficacy of the GAT neoadjuvant regimen in patients with stage III breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Gemcitabine, Adriamycine and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 10 sitesSpain
- Study dates
- Mar 2003to Jan 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage III breast cancer disease, with histological confirmation by true-cut or open-biopsy.
- Ages between 18 and 75 years old. Patients older than 70 must have an adequate quality of life to be eligible.
- Patients cannot have received previous treatment with chemotherapy, hormone therapy, radiotherapy or immune therapy.
- Performance status of 0,1, 2 Eastern Cooperative Oncology Group (ECOG).
- At least a 6 month life expectancy.
- Neutrophils > 1500; platelets > 100000; haemoglobin > 10 mg/dL.
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- Adequate renal and hepatic functions, with serum creatinine < 1.2 mg/dl and total bilirubin < 2 mg/dl.
- Adequate contraceptive methods during the study and up to 3 months after.
- Adequate cardiac function assessed by physical exam, electrocardiogram and left ventricular ejection fraction > 55%.
Who cannot join
- Inflammatory carcinoma or stage I, II or IV breast cancer disease.
- Males.
- Active infection.
- Other neoplasms except for basal skin carcinoma or cervical in situ carcinoma adequately treated. Other previous neoplasms are allowed if diagnosed and treated more than 5 years before study registration.
- Concomitant serious disease provoking organ failure (heart, renal, hepatic, respiratory).
- Pre-existing motor or sensorial neuropathy > grade 1.
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- Inability for treatment compliance.
- History of hypersensitivity to compounds such as cremophor, cyclosporine or vitamin K.
- History of arrhythmias or congestive heart failure, even when controlled; or active cardiac blocking of second or third grade.
- History of myocardial infarction in the previous 6 months.
- Hypertension not controlled.
- Pregnant or lactating women.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Complejo Hospitalario Unviesitario A Coruña
A Coruña, 15006
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, 28922
Hospital Infanta Cristina
Badajoz, 06080
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916
Complejo Hospitalario de Jaén
Jaén, 23007
Hospital Universitario La Princesa
Madrid, 28006
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Hospital General Universitario de Valencia
Valencia, 46014
Hospital Universitario Miguel Servet
Zaragoza, 50009
About this study
Official title: Phase II Pharmacogenomic and Clinical Trial for the Administration of Gemcitabine-doxorubicin-paclitaxel (GAT) as Neoadjuvant Treatment of Patients With Stage III Breast Cancer
This is a multicenter, open-label, phase II trial to assess the efficacy of the GAT neoadjuvant regimen in patients with stage III breast cancer.
Read the detailed description
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%.
- Conditions
- Breast Cancer
- Being tested
- Gemcitabine, Adriamycine, Paclitaxel
- Keywords
- Neoadjuvant chemotherapy., Stage III disease.
- Medical subject headings
- Breast Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar
AdriamycineDrug
Also called doxorubicin
PaclitaxelDrug
Also called Taxol
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine + Adriamycine + Paclitaxel | Experimental | Neoadjuvant chemotherapy consisted of adriamycine 40 mg/m2, administered on day 1 as an i.v. infusion. Paclitaxel 150 mg/m2 was administered on day 2 as an i.v infusion followed by gemcitabine 2000 mg/m2 as an i.v. infusion. The three drugs were administered every two weeks for 6 cycles. Receives: Drug: Gemcitabine; Drug: Adriamycine; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR) rate
pCR is defined as no invasive cells identifiable in breast sections at surgery. Response will be measured by physical exam and breast imaging before surgery and will be evaluated according to the World Health Organization (WHO) criteria. Pathological response after surgery, will be based on the proportion of remaining tumor and post-chemotherapy changes, evaluating separately the response in the breast and in the axilla lymph nodes.
Measured: Up to week 15
Secondary outcomes (5)
Overall response rate (ORR)
Tumor response is defined as the percentage of patients with a complete or partial response out of the patients who had measurable disease at baseline.
Measured: Up to week 12
Conservative surgery rate
To determine the percentage of conservative surgery rate versus other surgery
Measured: Up to week 15
The Number of Participants Who Experienced Adverse Events (AE)
According to the Common Terminology Criteria for Adverse Events (CTCAE) version 2.0
Measured: Through study treatment up to surgery
Disease-free survival
Time from the start of treatment to the progression of the disease (if it happens)
Measured: Up to 5 years since surgery
Tissue molecular markers and their correlation with response
Evaluation of changes in the tumor marker profile before and after treatment in tumor samples obtained before and after chemotherapy treatment.
Measured: Up to week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2005 (estimated)
- Study startMar 2003
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Breast Cancer Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Hospital Miguel ServetStudy Director, Study director, Complejo Hospitalrio de Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128856
- Sponsor's protocol ID
- GEICAM 2002-01
- Status last verified
- Mar 2023
- First submitted
- 9 Aug 2005
- Last updated
- 6 Mar 2023
- Results posted
- No
Publications
Sanchez-Rovira P, Anton A, Barnadas A, Velasco A, Lomas M, Rodriguez-Pinilla M, Ramirez JL, Ramirez C, Rios MJ, Castella E, Garcia-Andrade C, San Antonio B, Carrasco E, Palacios JL. Classical markers like ER and ki-67, but also survivin and pERK, could be involved in the pathological response to gemcitabine, adriamycin and paclitaxel (GAT) in locally advanced breast cancer patients: results from the GEICAM/2002-01 phase II study. Clin Transl Oncol. 2012 Jun;14(6):430-6. doi: 10.1007/s12094-012-0820-4.
PubMed 22634531
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Pharmacogenomic and Clinical Trial for the Administration of Gemcitabine-doxorubicin-paclitaxel (GAT) as Neoadjuvant Treatment of Patients With Stage III Breast Cancer
- ClinicalTrials.gov ID
- NCT00128856
- Acronym / sponsor ID
- GEICAM 2002-01
- Conditions
- Breast Cancer
- Keywords
- Neoadjuvant chemotherapy., Stage III disease.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Spanish Breast Cancer Research GroupUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, Bristol-Myers Squibb
- Study start
- Mar 2003 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 10 Aug 2005 (estimated)
- 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.
This is a multicenter, open-label, phase II trial to assess the efficacy of the GAT neoadjuvant regimen in patients with stage III breast cancer.
Detailed description
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine + Adriamycine + Paclitaxel | Experimental | Drug: Gemcitabine, Drug: Adriamycine, Drug: PaclitaxelNeoadjuvant chemotherapy consisted of adriamycine 40 mg/m2, administered on day 1 as an i.v. infusion. Paclitaxel 150 mg/m2 was administered on day 2 as an i.v infusion followed by gemcitabine 2000 mg/m2 as an i.v. infusion. The three drugs were administered every two weeks for 6 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Stage III breast cancer disease, with histological confirmation by true-cut or open-biopsy.
- Ages between 18 and 75 years old. Patients older than 70 must have an adequate quality of life to be eligible.
- Patients cannot have received previous treatment with chemotherapy, hormone therapy, radiotherapy or immune therapy.
- Performance status of 0,1, 2 Eastern Cooperative Oncology Group (ECOG).
- At least a 6 month life expectancy.
Key exclusion criteria (12 listed)
- Inflammatory carcinoma or stage I, II or IV breast cancer disease.
- Males.
- Active infection.
- Other neoplasms except for basal skin carcinoma or cervical in situ carcinoma adequately treated. Other previous neoplasms are allowed if diagnosed and treated more than 5 years before study registration.
- Concomitant serious disease provoking organ failure (heart, renal, hepatic, respiratory).
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 |
|---|---|---|
| GemcitabineAlso: Gemzar | Drug | Gemcitabine + Adriamycine + Paclitaxel |
| AdriamycineAlso: doxorubicin | Drug | Gemcitabine + Adriamycine + Paclitaxel |
| PaclitaxelAlso: Taxol | Drug | Gemcitabine + Adriamycine + Paclitaxel |
Primary outcome
Pathological complete response (pCR) rate
Time frame: Up to week 15
pCR is defined as no invasive cells identifiable in breast sections at surgery. Response will be measured by physical exam and breast imaging before surgery and will be evaluated according to the World Health Organization (WHO) criteria. Pathological response after surgery, will be based on the proportion of remaining tumor and post-chemotherapy changes, evaluating separately the response in the breast and in the axilla lymph nodes.
5 secondary outcomes
Overall response rate (ORR)
Time frame: Up to week 12
Conservative surgery rate
Time frame: Up to week 15
The Number of Participants Who Experienced Adverse Events (AE)
Time frame: Through study treatment up to surgery
Disease-free survival
Time frame: Up to 5 years since surgery
Tissue molecular markers and their correlation with response
Time frame: Up to week 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Results publication: PubMed 22634531Sanchez-Rovira P, Anton A, Barnadas A, Velasco A, Lomas M, Rodriguez-Pinilla M, Ramirez JL, Ramirez C, Rios MJ, Castella E, Garcia-Andrade C, San Antonio B, Carrasco E, Palacios JL. Classical markers like ER and ki-67, but also survivin and pERK, could be involved in the pathological response to gemcitabine, adriamycin and paclitaxel (GAT) in locally advanced breast cancer patients: results from the GEICAM/2002-01 phase II study. Clin Transl Oncol. 2012 Jun;14(6):430-6. doi: 10.1007/s12094-012-0820-4.
- Description Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research GroupLink provided by the sponsor.
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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.
Study Director study director
Hospital Miguel Servet
Study Director study director
Complejo Hospitalrio de Jaén
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine, Adriamycine and Paclitaxel in people with Breast Cancer, run by Spanish Breast Cancer Research Group at 10 sites in Spain.
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 9 inclusion and 12 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: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pathological complete response (pCR) rate (time frame: Up to week 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00128856, which also lists 1 linked publication.
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 6 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.