Breast NeoplasmsPhase 3NCT00174707
Study of Docetaxel in Breast Cancer Patients
A Phase 3 study testing epidoxorubicine, ciclophosphamide, methotrexate, fluorouracile, epidoxorubicine, docetaxel, ciclophosphamide, methotrexate, fluorouracile and epidoxorubicine, docetaxel, cyclophosphamide in people with Breast Neoplasms, run by Sanofi at 1 site in Italy.
Trial summary
Primary objectives: To compare the disease free survival (DFS) in patients treated with the sequential epidoxorubicin, cyclophosphamide, methotrexate, and fluorouracil (CMF) regimen to that in patients treated with the same treatment plus docetaxel given sequentially after epidoxorubicin Secondary objectives: To… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- epidoxorubicine, ciclophosphamide, methotrexate, fluorouracile, epidoxorubicine, docetaxel, ciclophosphamide, methotrexate, fluorouracile and epidoxorubicine, docetaxel, cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 998 participants
- Where
- 1 siteItaly
- Study dates
- Dec 1997to Dec 2007
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven breast cancer at the first diagnosis with > or = 4 axillary nodes showing evidence of tumor among a minimum of 10 resected lymph nodes (American Joint Committee on Cancer 1992 pathologic staging pT1-4, pN1-2 [at least 1/10], M0)
- Ages ≥ 18 years and ≤ 70 years for patients who will be randomized to arm A and B. Ages ≥ 18 years and ≤ 65 years for patients who will be randomized to arm C
- World Health Organization performance status 0-1
- Definitive surgical treatment must be either mastectomy or breast conserving surgery, with axillary lymph node dissection for operable breast cancer (clinical T1-3, N1, M0). Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in situ. Lobular carcinoma in situ does not count as a positive margin. Patients with histologically-documented infiltration of the skin (pT4a) will be also eligible
- Surgical procedures completed within 8 weeks from the randomization.
- Laboratory requirements:
Show all 18Show fewer
- Hematology :
- Neutrophils ≥ 2 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Hemoglobin ≥ 10 g/DL
- Hepatic function:
- Total bilirubin ≤ 1 time the upper-normal limits of the institutional normal values.
- ASAT \& ALAT ≤ 2.5 UNL, alkaline phosphatase ≤ 5 UNL. Patients with ASAT \&/or ALAT > 1.5 x UNL associated with alkaline phosphatase > 2.5 x UNL are not eligible for the study
- Renal function :
- Creatinine ≤ 140 µmol/L (1.6 mg/DL); if limit values, the creatinine clearance should be performed and should be ≥ 60 ml/min
- Normal left ventricular ejection fraction or superior to the lower limits of the institution
- Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating center
- Complete work-up within 3 months prior to randomization. All patients will have bilateral mammography, chest X rays (posteroanterior [PA] and lateral), abdominal ultrasound and/or computed tomography scan, \& bone scan
Who cannot join
- Axillary lymph nodes free of involvement
- Primary breast cancer with histology other than adenocarcinoma
- Inflammatory carcinoma
- Any locally advanced (T4 and/or N2-known N3) or metastatic (M1) breast cancer
- Past or current history of ipsilateral or contralateral invasive or contralateral ductal in situ breast carcinoma. A past or current history of ipsilateral ductal in situ or lobular in situ (ipsilateral or contralateral) breast carcinoma is not an exclusion criterion
- Histologically positive resection margins. Patients undergoing conservative resection margins can be considered eligible if radically resected within 4 weeks from randomization
Show all 22Show fewer
- Pregnant or lactating women or women of childbearing potential (e.g. not using adequate contraception)
- History of prior or concomitant malignancies other than curatively treated basal cell skin cancer or excised cervical carcinoma in situ
- Symptomatic peripheral neuropathy > grade 2 according to the National Cancer Institute Common Toxicity Criteria
- Other serious illnesses or medical conditions:
- Congestive heart failure or angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled high risk hypertension or arrhythmias
- History of significant neurologic or psychiatric disorders including dementia or seizures
- Active infection
- Peptic ulcer, unstable diabetes mellitus or other contraindications for the use of dexamethasone
- Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational regimen within 30 days prior to study entry
- Concurrent treatment with any other anti-cancer therapy
- Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment should be stopped before study entry
- Prior systemic anticancer therapy for breast cancer (chemotherapy, hormonal therapy, immunotherapy, etc.) as adjuvant and/or neo-adjuvant therapy
- Concomitant treatment with corticosteroids used for reasons other than premedication; however, patients receiving chronic treatment with corticosteroids (>6 months) at low dose (≤ 20 mg of methylprednisolone or equivalent dose of other corticosteroids) for whichever reason are eligible
- Definite contraindications for the use of corticosteroids as premedication
- Prior radiation therapy
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III Randomized Study of Sequential Epidoxorubicin Followed By CMF: Cyclophosphamide+Methotrexate+Fluorouracil (Arm A) Versus Sequential Epidoxorubicin Followed By Docetaxel Followed By CMF (Arm B) Versus Sequential Intensified Epidoxorubicin Followed By Docetaxel Followed By High-Dose Cyclophosphamide (Arm C) in Early Breast Cancer Patients With Positive Axillary Lymph Nodes
Primary objectives:
- To compare the disease free survival (DFS) in patients treated with the sequential epidoxorubicin, cyclophosphamide, methotrexate, and fluorouracil (CMF) regimen to that in patients treated with the same treatment plus docetaxel given sequentially after epidoxorubicin
Read more
Secondary objectives:
- To compare the DFS in patients treated with the sequential epidoxorubicin, docetaxel and CMF (only patients with > or = 4 lymph nodes) regimen to that in patients treated with sequential intensified epidoxorubicin/docetaxel/high dose (HD) cyclophosphamide regimen
- To evaluate the overall survival in each arm
- To evaluate the tolerability of a sequential intensified epidoxorubicin/docetaxel/HD-cyclophosphamide (arm C)
- To compare the safety of a sequential epidoxorubicin/docetaxel/CMF (arm B) regimen versus a standard sequential epidoxorubicin/CMF regimen (arm A)
- Conditions
- Breast Neoplasms
- Being tested
- epidoxorubicine, ciclophosphamide, methotrexate, fluorouracile, epidoxorubicine, docetaxel, ciclophosphamide, methotrexate, fluorouracile, epidoxorubicine, docetaxel, cyclophosphamide
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidoxorubicine, ciclophosphamide, methotrexate, fluorouracileDrug
Sequential Epidoxorubicin followed by ciclophosphamide/Methotrexate/fluorouracile (±TAM)
epidoxorubicine, docetaxel, ciclophosphamide, methotrexate, fluorouracileDrug
Sequential Epidoxorubicin followed by Docetaxel followed by ciclophosphamide/methotrexate/fluorouracile (± TAM)
epidoxorubicine, docetaxel, cyclophosphamideDrug
Sequential Intensified Epidoxorubicin followed by Docetaxel followed by Cyclophosphamide (± TAM)
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Sequential Epidoxorubicin followed by CMF: ciclophosphamide/Methotrexate/fluorouracile (±TAM: tamoxifen) Receives: Drug: epidoxorubicine, ciclophosphamide, methotrexate, fluorouracile |
| B | Experimental | Sequential Epidoxorubicin followed by Docetaxel followed by ciclophosphamide/methotrexate/fluorouracile (± TAM) Receives: Drug: epidoxorubicine, docetaxel, ciclophosphamide, methotrexate, fluorouracile |
| C | Experimental | Sequential Intensified Epidoxorubicin followed by Docetaxel followed by Cyclophosphamide (± TAM) Receives: Drug: epidoxorubicine, docetaxel, cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive Disease-Free Survival (IDFS) - with exclusion of ductal carcinoma in situ- DCIS- either collateral or ipsilateral, according to STEEP in adjuvant breast cancer trial: Standardized Definitions for Efficacy Endpoints
Measured: Time between randomization date and date of local or distant recurrence or contralateral breast cancer or second primary (non breast) cancer or death from any cause, whichever occurs first
Secondary outcomes (3)
Recurrence-Free Survival (RFS)
Measured: Time between the date of randomization and the date of local or distant recurrence or death from any cause, whichever occurs first, thus excluding contralateral breast cancer or second primary (non breast) cancers
Overall Survival (OS)
Measured: Time between the date of randomization and date of death
Distant Disease-Free Survival (DDFS)
Measured: Time betwen the date of randomization and the date of distant recurrence or death from any cause, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startDec 1997
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- 998 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Georges Paizis, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174707
- Sponsor's protocol ID
- TAX_IT1_302
- Other IDs
- TAX_IT_216
- Status last verified
- Dec 2009
- First submitted
- 12 Sep 2005
- Last updated
- 7 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Study of Sequential Epidoxorubicin Followed By CMF: Cyclophosphamide+Methotrexate+Fluorouracil (Arm A) Versus Sequential Epidoxorubicin Followed By Docetaxel Followed By CMF (Arm B) Versus Sequential Intensified Epidoxorubicin Followed By Docetaxel Followed By High-Dose Cyclophosphamide (Arm C) in Early Breast Cancer Patients With Positive Axillary Lymph Nodes
- ClinicalTrials.gov ID
- NCT00174707
- Acronym / sponsor ID
- TAX_IT1_302
- Conditions
- Breast Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 998 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 1997
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 15 Sep 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.
Primary objectives:
- To compare the disease free survival (DFS) in patients treated with the sequential epidoxorubicin, cyclophosphamide, methotrexate, and fluorouracil (CMF) regimen to that in patients treated with the same treatment plus docetaxel given sequentially after epidoxorubicin
Secondary objectives:
- To compare the DFS in patients treated with the sequential epidoxorubicin, docetaxel and CMF (only patients with > or = 4 lymph nodes) regimen to that in patients treated with sequential intensified epidoxorubicin/docetaxel/high dose (HD) cyclophosphamide regimen
- To evaluate the overall survival in each arm
- To evaluate the tolerability of a sequential intensified epidoxorubicin/docetaxel/HD-cyclophosphamide (arm C)
- To compare the safety of a sequential epidoxorubicin/docetaxel/CMF (arm B) regimen versus a standard sequential epidoxorubicin/CMF regimen (arm A)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: epidoxorubicine, ciclophosphamide, methotrexate, fluorouracileSequential Epidoxorubicin followed by CMF: ciclophosphamide/Methotrexate/fluorouracile (±TAM: tamoxifen) |
| B | Experimental | Drug: epidoxorubicine, docetaxel, ciclophosphamide, methotrexate, fluorouracileSequential Epidoxorubicin followed by Docetaxel followed by ciclophosphamide/methotrexate/fluorouracile (± TAM) |
| C | Experimental | Drug: epidoxorubicine, docetaxel, cyclophosphamideSequential Intensified Epidoxorubicin followed by Docetaxel followed by Cyclophosphamide (± TAM) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically proven breast cancer at the first diagnosis with > or = 4 axillary nodes showing evidence of tumor among a minimum of 10 resected lymph nodes (American Joint Committee on Cancer 1992 pathologic staging pT1-4, pN1-2 [at least 1/10], M0)
- Ages ≥ 18 years and ≤ 70 years for patients who will be randomized to arm A and B. Ages ≥ 18 years and ≤ 65 years for patients who will be randomized to arm C
- World Health Organization performance status 0-1
- Definitive surgical treatment must be either mastectomy or breast conserving surgery, with axillary lymph node dissection for operable breast cancer (clinical T1-3, N1, M0). Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in situ. Lobular carcinoma in situ does not count as a positive margin. Patients with histologically-documented infiltration of the skin (pT4a) will be also eligible
- Surgical procedures completed within 8 weeks from the randomization.
Key exclusion criteria (22 listed)
- Axillary lymph nodes free of involvement
- Primary breast cancer with histology other than adenocarcinoma
- Inflammatory carcinoma
- Any locally advanced (T4 and/or N2-known N3) or metastatic (M1) breast cancer
- Past or current history of ipsilateral or contralateral invasive or contralateral ductal in situ breast carcinoma. A past or current history of ipsilateral ductal in situ or lobular in situ (ipsilateral or contralateral) breast carcinoma is not an exclusion criterion
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 |
|---|---|---|
| epidoxorubicine, ciclophosphamide, methotrexate, fluorouracileSequential Epidoxorubicin followed by ciclophosphamide/Methotrexate/fluorouracile (±TAM) | Drug | A |
| epidoxorubicine, docetaxel, ciclophosphamide, methotrexate, fluorouracileSequential Epidoxorubicin followed by Docetaxel followed by ciclophosphamide/methotrexate/fluorouracile (± TAM) | Drug | B |
| epidoxorubicine, docetaxel, cyclophosphamideSequential Intensified Epidoxorubicin followed by Docetaxel followed by Cyclophosphamide (± TAM) | Drug | C |
Primary outcome
Invasive Disease-Free Survival (IDFS) - with exclusion of ductal carcinoma in situ- DCIS- either collateral or ipsilateral, according to STEEP in adjuvant breast cancer trial: Standardized Definitions for Efficacy Endpoints
Time frame: Time between randomization date and date of local or distant recurrence or contralateral breast cancer or second primary (non breast) cancer or death from any cause, whichever occurs first
3 secondary outcomes
Recurrence-Free Survival (RFS)
Time frame: Time between the date of randomization and the date of local or distant recurrence or death from any cause, whichever occurs first, thus excluding contralateral breast cancer or second primary (non breast) cancers
Overall Survival (OS)
Time frame: Time between the date of randomization and date of death
Distant Disease-Free Survival (DDFS)
Time frame: Time betwen the date of randomization and the date of distant recurrence or death from any cause, whichever occurs first
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 7 Dec 2009.
Related trials for Breast Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Georges Paizis, MD study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing epidoxorubicine, ciclophosphamide, methotrexate, fluorouracile, epidoxorubicine, docetaxel, ciclophosphamide, methotrexate, fluorouracile and epidoxorubicine, docetaxel, cyclophosphamide in people with Breast Neoplasms, run by Sanofi at 1 site in Italy.
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 18 inclusion and 22 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 7 Dec 2009. 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 Italy. 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?
Invasive Disease-Free Survival (IDFS) - with exclusion of ductal carcinoma in situ- DCIS- either collateral or ipsilateral, according to STEEP in adjuvant breast cancer trial: Standardized Definitions for Efficacy Endpoints (time frame: Time between randomization date and date of local or distant recurrence or contralateral breast cancer or second primary (non breast) cancer or death from any cause, whichever occurs first). 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 7 Dec 2009; AzTrials last refreshed its copy on 7 Nov 2026.