Breast CancerPhase 3NCT00294385
Study Comparing Concomitant Docetaxel + Gemcitabine to Sequential Therapy of Docetaxel Followed by Gemcitabine
A Phase 3 study testing Docetaxel and Gemcitabine, Docetaxel in people with Breast Cancer, run by Central European Cooperative Oncology Group at 18 sites in 7 countries.
Trial summary
The purpose of this study is to compare the Time To Disease Progression (TTDP) between those patients with unresectable, locally recurrent or metastatic breast cancer who are treated with concomitant Docetaxel plus Gemcitabine to those patients treated with sequential therapy of Docetaxel followed by Gemcitabine. 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?
- Docetaxel and Gemcitabine, Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 18 sitesin 7 countries
- Study dates
- Jun 2002to Oct 2005
- Phase
- Phase 3
- 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
- Patients with histologic or cytologic diagnosis of breast cancer with evidence of unresectable, locally recurrent, or metastatic disease.
- Females, 18 to 75 years of age
- pre-treated with ONE anthracyclines containing chemotherapy either in neoadjuvant/adjuvant or 1st line metastatic setting will be enrolled into the study
- Patients with clinically measurable lesions will be enrolled in this study. Measurability is determined according to RECIST criteria
- Performance status of 70 or higher on the Karnofsky Performance Scale
- Adequate bone marrow reserve
Show all 10Show fewer
- Adequate liver function
- Adequate renal function
- Informed consent form patient or guardian
- Childbearing potential either terminated by surgery, radiation, or menopause, use of an approved contraceptive method
Who cannot join
- Active infection (at the discretion of the investigator).
- Known or suspected brain metastases requiring steroid or radiation treatment.
- Pregnancy (recent negative urine pregnancy test for pre-menopausal patients mandatory)
- Breast-feeding
- Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin).
- Bone metastases, pleural effusion, or ascites as the only site of disease.
- Bone marrow transplantation or autologous stern cell infusion following high-dose chemotherapy for adjuvant or metastatic disease.
Trial locations and contacts
18 sites in 7 countries.
18 sites in 7 countries
Czechia5 sites
FN U sv. Anny
Brno, 656 91
Nemocnice Ceske Budejovice
Ceske
FN Hradec Kralove
Hradec Králové, 500 02
FN Bulovka
Prague, 186 00
Charles University Prague, Dep of Oncology
Prague
Austria3 sites
2. Med. Abteilung - LKH-Steyr
Steyr, 4400
Hanusch KrankenhausHämatologisch-Onkologisches Zentrum
Vienna, 1140
Intere IV Krankenhaus Wels
Wels, 4600
Bulgaria3 sites
Cancer Center Plovdiv
Plovdiv, 4000
SBALO National Oncology Center
Sofia, 1527
SBALO National Oncology Center
Sofia, 1756
Israel3 sites
Rambam Medical Center, Oncol. Dep
Haifa, 31096
Tel Aviv Sourasky Medical Center, Div of Oncology
Tel Aviv
"Sheba" Medical Center, Dep of Oncology
Tel HaShomer
Lebanon2 sites
American University of Beirut, Medical Center
Beirut
Rizk Hospital
Beirut
About this study
Official title: A Randomized Phase III Study Comparing Concomitant Docetaxel Plus Gemcitabine to Sequential Therapy of Docetaxel Followed by Gemcitabine in Anthracycline-Pretreated Metastatic or Locally Recurrent Breast Cancer Patients
The purpose of this study is to compare the Time To Disease Progression (TTDP) between those patients with unresectable, locally recurrent or metastatic breast cancer who are treated with concomitant Docetaxel plus Gemcitabine to those patients treated with sequential therapy of Docetaxel followed by Gemcitabine.
Read the detailed description
This is an open, multicenter, two-armed Phase III study
Patients will be randomized to either of the following two arms:
Arm A (concomitant arm), Gemcitabine 1000 mglm2 will be administered intravenously on Days 1 and 8, repeated on Day 22. Docetaxel 75 mg/m2 will be given on Day 8 (before Gemcitabine), repeated on Day 22. This 3-week schedule defines a cycle of treatment for this arm. Overall 8 cycles will be administered.
Arm B (sequential arm) four cycles of Docetaxel 100 mg/m2 an Day 1, repeated an Day 22, followed by four cycles of Gemcitabine 1250 mg/m2 an a Day 1 and 8, repeated an Day 22, will be given. Both drugs will be administered in a 3-week schedule.
Bimonthly follow-up for patients without confirmed disease progression until progression of disease. Long-term follow-up for patients with confirmed disease progression will be done in 4 intervals.
For therapy control frequent blood chemistry and hematology, physical examination, weight control, potential adverse events and imaging procedures (CT, X-ray, MRI, Bone scan) am foreseen.
- Conditions
- Breast Cancer
- Being tested
- Docetaxel, Gemcitabine, Docetaxel
- Keywords
- Breast Cancer, Docetaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Gemcitabine, DocetaxelDrug
Arm A (concomitant arm), Gemcitabine 1000 mglm2 will be administered intravenously on Days 1 and 8, repeated on Day 22. Docetaxel 75 mg/m2 will be given on Day 8 (before Gemcitabine), repeated on Day 22. This 3-week schedule defines a cycle of treatment for this arm. Overall 8 cycles will be administered.
DocetaxelDrug
rm B (sequential arm) four cycles of Docetaxel 100 mg/m2 an Day 1, repeated an Day 22, followed by four cycles of Gemcitabine 1250 mg/m2 an a Day 1 and 8, repeated an Day 22, will be given. Both drugs will be administered in a 3-week schedule.
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine, Docetaxel | Active comparator | Arm A (concomitant arm), Gemcitabine 1000 mglm2 will be administered intravenously on Days 1 and 8, repeated on Day 22. Docetaxel 75 mg/m2 will be given on Day 8 (before Gemcitabine), repeated on Day 22. This 3-week schedule defines a cycle of treatment for this arm. Overall 8 cycles will be administered. Receives: Drug: Docetaxel; Drug: Gemcitabine, Docetaxel |
| Docetaxel | Active comparator | Arm B (sequential arm) four cycles of Docetaxel 100 mg/m2 an Day 1, repeated an Day 22, followed by four cycles of Gemcitabine 1250 mg/m2 an a Day 1 and 8, repeated an Day 22, will be given. Both drugs will be administered in a 3-week schedule. Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
to compare the Time To Disease Progression between those patients with unresectable, locally recurrent or metastatic breast cancer who are treated with concomitant Docetaxel plus Gemcitabine to those patients treated with sequential therapy of Doc
Secondary outcomes (5)
Overall response rate
Response duration
Overall survival
Characterize changes in performance status, patient-reported pain, and disease-related symptoms in each arm
Characterize the nature of the toxicities experienced in each arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2006 (estimated)
- Study startJun 2002
- Study completionOct 2005
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central European Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Investigators
- Christoph Wiltschke, Prof, Principal investigator, Univ. Klinik f. Innere Medizin I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00294385
- Sponsor's protocol ID
- CECOG/BC 1.3.002
- Status last verified
- Jun 2011
- First submitted
- 20 Feb 2006
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Study Comparing Concomitant Docetaxel Plus Gemcitabine to Sequential Therapy of Docetaxel Followed by Gemcitabine in Anthracycline-Pretreated Metastatic or Locally Recurrent Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00294385
- Acronym / sponsor ID
- CECOG/BC 1.3.002
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Docetaxel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Central European Cooperative Oncology GroupUniversity, hospital or other
- Study start
- Jun 2002
- Study completion
- Oct 2005 (actual)
- First posted
- 22 Feb 2006 (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.
The purpose of this study is to compare the Time To Disease Progression (TTDP) between those patients with unresectable, locally recurrent or metastatic breast cancer who are treated with concomitant Docetaxel plus Gemcitabine to those patients treated with sequential therapy of Docetaxel followed by Gemcitabine.
Detailed description
This is an open, multicenter, two-armed Phase III study
Patients will be randomized to either of the following two arms:
Arm A (concomitant arm), Gemcitabine 1000 mglm2 will be administered intravenously on Days 1 and 8, repeated on Day 22. Docetaxel 75 mg/m2 will be given on Day 8 (before Gemcitabine), repeated on Day 22. This 3-week schedule defines a cycle of treatment for this arm. Overall 8 cycles will be administered.
Arm B (sequential arm) four cycles of Docetaxel 100 mg/m2 an Day 1, repeated an Day 22, followed by four cycles of Gemcitabine 1250 mg/m2 an a Day 1 and 8, repeated an Day 22, will be given. Both drugs will be administered in a 3-week schedule.
Bimonthly follow-up for patients without confirmed disease progression until progression of disease. Long-term follow-up for patients with confirmed disease progression will be done in 4 intervals.
For therapy control frequent blood chemistry and hematology, physical examination, weight control, potential adverse events and imaging procedures (CT, X-ray, MRI, Bone scan) am foreseen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine, Docetaxel | Active comparator | Drug: Docetaxel, Drug: Gemcitabine, DocetaxelArm A (concomitant arm), Gemcitabine 1000 mglm2 will be administered intravenously on Days 1 and 8, repeated on Day 22. Docetaxel 75 mg/m2 will be given on Day 8 (before Gemcitabine), repeated on Day 22. This 3-week schedule defines a cycle of treatment for this arm. Overall 8 cycles will be administered. |
| Docetaxel | Active comparator | Drug: DocetaxelArm B (sequential arm) four cycles of Docetaxel 100 mg/m2 an Day 1, repeated an Day 22, followed by four cycles of Gemcitabine 1250 mg/m2 an a Day 1 and 8, repeated an Day 22, will be given. Both drugs will be administered in a 3-week schedule. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with histologic or cytologic diagnosis of breast cancer with evidence of unresectable, locally recurrent, or metastatic disease.
- Females, 18 to 75 years of age
- pre-treated with ONE anthracyclines containing chemotherapy either in neoadjuvant/adjuvant or 1st line metastatic setting will be enrolled into the study
- Patients with clinically measurable lesions will be enrolled in this study. Measurability is determined according to RECIST criteria
- Performance status of 70 or higher on the Karnofsky Performance Scale
Key exclusion criteria (8 listed)
- Active infection (at the discretion of the investigator).
- Known or suspected brain metastases requiring steroid or radiation treatment.
- Pregnancy (recent negative urine pregnancy test for pre-menopausal patients mandatory)
- Breast-feeding
- Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
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 |
|---|---|---|
| Docetaxel | Drug | Docetaxel, Gemcitabine, Docetaxel |
| Gemcitabine, DocetaxelArm A (concomitant arm), Gemcitabine 1000 mglm2 will be administered intravenously on Days 1 and 8, repeated on Day 22. Docetaxel 75 mg/m2 will be given on Day 8 (before Gemcitabine), repeated on Day 22. This 3-week schedule defines a cycle of treatment for this arm. Overall 8 cycles will be administered. | Drug | Gemcitabine, Docetaxel |
| Docetaxelrm B (sequential arm) four cycles of Docetaxel 100 mg/m2 an Day 1, repeated an Day 22, followed by four cycles of Gemcitabine 1250 mg/m2 an a Day 1 and 8, repeated an Day 22, will be given. Both drugs will be administered in a 3-week schedule. | Drug | Docetaxel |
Primary outcome
to compare the Time To Disease Progression between those patients with unresectable, locally recurrent or metastatic breast cancer who are treated with concomitant Docetaxel plus Gemcitabine to those patients treated with sequential therapy of Doc
5 secondary outcomes
Overall response rate
Response duration
Overall survival
Characterize changes in performance status, patient-reported pain, and disease-related symptoms in each arm
Characterize the nature of the toxicities experienced in each arm
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 23 Jun 2011.
Related trials for Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Not yet recruitingPhase 1
A Study to Evaluate the Effects of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Participants With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negatve Breast Cancer
Advanced or Metastatic Breast Cancer
Not yet recruitingPhase 2
Netupitant/Palonosetron for Prevention of Nausea and Vomiting in Breast Cancer ADC Therapy
Breast Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
Not yet recruiting
Molecular Subtype-Guided Postoperative Radiotherapy for Phyllodes Tumor of the Breast
Radiotherapy, Adjuvant, Phyllodes Breast Tumor
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.
Christoph Wiltschke, Prof principal investigator
Univ. Klinik f. Innere Medizin I
18 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docetaxel and Gemcitabine, Docetaxel in people with Breast Cancer, run by Central European Cooperative Oncology Group at 18 sites in 7 countries.
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 10 inclusion and 8 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 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Czechia, Austria, Bulgaria, Israel, Lebanon and 2 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
to compare the Time To Disease Progression between those patients with unresectable, locally recurrent or metastatic breast cancer who are treated with concomitant Docetaxel plus Gemcitabine to those patients treated with sequential therapy of Doc. 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 23 Jun 2011.