Breast CancerPhase 3NCT00053911
Combination Chemotherapy Compared With Observation After Surgery in Treating Women With Relapsed Nonmetastatic Breast Cancer
A Phase 3 study testing anastrozole, cyclophosphamide and docetaxel in people with Breast Cancer, run by UNICANCER at 26 sites in France.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them after surgery, may kill any remaining tumor cells following surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- anastrozole, cyclophosphamide and docetaxel
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 26 sitesFrance
- Study dates
- Nov 2002to Apr 2004
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the breast
- No contralateral breast cancer
- Local tumor recurrence more than 6 months after conservative surgery
- Complete or conservative resection of the recurrent tumor NOTE: Initial complete surgical resection not allowed
- No local inflammatory disease or disease that is not amenable to complete surgical resection
- No positive axillary lymph nodes
- No distant metastases, including subclavicular lymph nodes
- Hormone receptor status:
- Hormone receptor status known
PATIENT CHARACTERISTICS:
Age
- 18 to 65
Sex
- Female
Menopausal status
- Menopausal status known
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than upper limit of normal (ULN)
- Transaminases no greater than 1.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
- No chronic hepatitis B
- No active hepatitis C
Renal
- Not specified
Cardiovascular
- Cardiac function normal by echocardiogram or isotopes
Other
- No contraindications to anthracyclines such as any of the following:
- Prior doxorubicin over 300 mg/m^2
- Prior epirubicin over 600 mg/m^2
- Prior mitoxantrone over 90 mg/m^2
- No other invasive malignancy
- No chronic somatic or psychiatric condition that would preclude study participation
- No familial, social, geographic, or psychological reason that would preclude study participation
- Not pregnant
- Fertile patients must use effective contraception
- HIV negative
- CA 153 no greater than 2 times ULN
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Patient Characteristics-Other
- No prior neoadjuvant chemotherapy
Endocrine therapy
- No prior neoadjuvant hormonal therapy
Radiotherapy
- No prior neoadjuvant radiotherapy
Surgery
- See Disease Characteristics
- At least 41 days since prior surgery
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
France26 sites
Clinique Claude Bernard
Albi, 81000
Centre Paul Papin
Angers, 49036
Centre Hospitalier d'Annecy
Annecy, 74011 Cedex
Institut Sainte Catherine
Avignon, 84082
Institut Bergonie
Bordeaux, 33076
C.H. Bourg En Bresse
Bourg-en-Bresse, 01012
CHU Hopital A. Morvan
Brest, 29609
Centre Hospitalier General
Brivé, 19101
Centre Regional Francois Baclesse
Caen, 14076
Centre Jean Perrin
Clermont-Ferrand, 63011
Centre Hospitalier Compiegne
Compiègne, 60321
Clinique du Petit Colmouilins
Harfleur, 76700
Centre Oscar Lambret
Lille, 59020
Institut J. Paoli and I. Calmettes
Marseille, 13273
Hopital Notre-Dame de Bon Secours
Metz, 57038
C.H. General Andre Boulloche
Montbéliard, 25209
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, 34298
Centre Hospitalier de Mulhouse
Mulhouse, 68051
Centre Regional Rene Gauducheau
Nantes-Saint Herblain, 44805
Clinique Saint - Pierre
Perpignan
Centre Eugene Marquis
Rennes, 35042
Clinique Armoricaine De Radiologie
Saint Brieux, F-22015
Polyclinique de L'Ormeau
Tarbes, 65000
Institut Claudius Regaud
Toulouse, 31052
Hopital J. Ducuing
Toulouse
Institut Gustave Roussy
Villejuif, F-94805
About this study
Official title: Randomized And Multicentric Phase III Study Evaluating The Benefit By Using A Chemotherapy With FEC 100 And Docetaxel In Non Metastatic Breast Cancer Which Has Relapsed After A Conservative Surgery
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them after surgery, may kill any remaining tumor cells following surgery. It is not yet known whether combination chemotherapy is more effective than observation in treating relapsed nonmetastatic breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with that of observation in treating women who have undergone surgery for relapsed nonmetastatic breast cancer.
Read the detailed description
OBJECTIVES:
- Compare the efficacy of adjuvant cyclophosphamide, epirubicin, and fluorouracil vs observation, in terms of disease-free 5-year survival, in women who have undergone resection for relapsed nonmetastatic breast cancer after initial conservative surgery.
- Compare the overall survival of women treated with these regimens.
- Determine the tolerance of these women to the chemotherapy regimen.
- Correlate prognostic factors of survival with efficacy of the chemotherapy regimen in these women.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to menopausal status and participating center. Patients are randomized to 1 of 2 treatment arms. Study begins within 42 days after resection of recurrent disease.
- Arm I: Patients receive fluorouracil IV over 1 hour, epirubicin IV over 1 hour, and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients are examined on days 1 and 63.
Patients who are hormone receptor positive also receive one of the following hormonal therapy regimens, depending on menopausal status:
- Oral tamoxifen daily for 5 years
- Oral tamoxifen daily for 5 years and oral luteinizing hormone-releasing hormone (LHRH) agonist therapy (e.g., goserelin) for 3 years
- Oral LHRH agonist therapy (e.g., goserelin) for 3 years
- Oral antiaromatase therapy (e.g., anastrozole) for 5 years Patients also undergo radiotherapy and may also undergo second complete resection.
Patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 370 patients (185 per treatment arm) will be accrued for this study within 3 years.
- Conditions
- Breast Cancer
- Being tested
- anastrozole, cyclophosphamide, docetaxel, epirubicin hydrochloride, fluorouracil
- Keywords
- recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anastrozoleDrug
cyclophosphamideDrug
docetaxelDrug
epirubicin hydrochlorideDrug
fluorouracilDrug
goserelin acetateDrug
tamoxifen citrateDrug
adjuvant therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the disease free survival
Measured: 5 years
Secondary outcomes (1)
Evaluation of the overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2003 (estimated)
- Study startNov 2002
- Primary completionApr 2004
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.
- More trials run by UNICANCERThe 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
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Investigators
- Gilles Romieu, MD, Study chair, Institut du Cancer de Montpellier - Val d'Aurelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00053911
- Sponsor's protocol ID
- PACS03
- Other IDs
- FRE-FNCLCC-PACS-03/003, EU-20237
- Status last verified
- Dec 2014
- First submitted
- 5 Feb 2003
- Last updated
- 16 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized And Multicentric Phase III Study Evaluating The Benefit By Using A Chemotherapy With FEC 100 And Docetaxel In Non Metastatic Breast Cancer Which Has Relapsed After A Conservative Surgery
- ClinicalTrials.gov ID
- NCT00053911
- Acronym / sponsor ID
- PACS03
- Conditions
- Breast Cancer
- Keywords
- recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- Nov 2002
- Primary completion
- Apr 2004 (actual)
- First posted
- 6 Feb 2003 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them after surgery, may kill any remaining tumor cells following surgery. It is not yet known whether combination chemotherapy is more effective than observation in treating relapsed nonmetastatic breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with that of observation in treating women who have undergone surgery for relapsed nonmetastatic breast cancer.
Detailed description
OBJECTIVES:
- Compare the efficacy of adjuvant cyclophosphamide, epirubicin, and fluorouracil vs observation, in terms of disease-free 5-year survival, in women who have undergone resection for relapsed nonmetastatic breast cancer after initial conservative surgery.
- Compare the overall survival of women treated with these regimens.
- Determine the tolerance of these women to the chemotherapy regimen.
- Correlate prognostic factors of survival with efficacy of the chemotherapy regimen in these women.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to menopausal status and participating center. Patients are randomized to 1 of 2 treatment arms. Study begins within 42 days after resection of recurrent disease.
- Arm I: Patients receive fluorouracil IV over 1 hour, epirubicin IV over 1 hour, and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients are examined on days 1 and 63.
Patients who are hormone receptor positive also receive one of the following hormonal therapy regimens, depending on menopausal status:
- Oral tamoxifen daily for 5 years
- Oral tamoxifen daily for 5 years and oral luteinizing hormone-releasing hormone (LHRH) agonist therapy (e.g., goserelin) for 3 years
- Oral LHRH agonist therapy (e.g., goserelin) for 3 years
- Oral antiaromatase therapy (e.g., anastrozole) for 5 years Patients also undergo radiotherapy and may also undergo second complete resection.
Patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 370 patients (185 per treatment arm) will be accrued for this study within 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| anastrozole | Drug | – |
| cyclophosphamide | Drug | – |
| docetaxel | Drug | – |
| epirubicin hydrochloride | Drug | – |
| fluorouracil | Drug | – |
| goserelin acetate | Drug | – |
| tamoxifen citrate | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
Primary outcome
Evaluation of the disease free survival
Time frame: 5 years
1 secondary outcome
Evaluation of the overall survival
Time frame: 5 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2014.
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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.
Gilles Romieu, MD study chair
Institut du Cancer de Montpellier - Val d'Aurelle
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing anastrozole, cyclophosphamide and docetaxel in people with Breast Cancer, run by UNICANCER at 26 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 16 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in France. 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 was stopped early. Results are not available in the source record.
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?
Evaluation of the disease free survival (time frame: 5 years). 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 16 Dec 2014.