Breast CancerPhase 3NCT00010140
Epirubicin and Tamoxifen With or Without Docetaxel in Treating Postmenopausal Women With Breast Cancer
A Phase 3 study testing docetaxel, epirubicin hydrochloride and tamoxifen citrate in people with Breast Cancer, run by International Collaborative Cancer Group at 1 site in United Kingdom.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. Combining chemotherapy with hormone therapy may kill more tumor cells. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- docetaxel, epirubicin hydrochloride and tamoxifen citrate
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 1997to not given
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically proven node-positive breast cancer
- Postmenopausal
- Last menstrual period more than 12 months before initial surgery OR
- Any age with prior bilateral oophorectomy OR
- Age 50 or over with prior hysterectomy without oophorectomy (unrelated to malignancy)
- No distant metastases
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- See Disease Characteristics
Sex:
- Female
Menopausal status:
- See Disease Characteristics
Performance status:
- WHO (ECOG) 0-1
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm3 OR
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Bilirubin normal
- SGOT and SGPT no greater than 1.5 times normal
- Alkaline phosphatase no greater than 1.5 times normal
Renal:
- Creatinine less than 1.5 times normal
Cardiovascular:
- No history of significant angina, congestive heart failure, or myocardial infarction within the past year
- No clinically significant arrhythmias or uncontrolled hypertension
- LVEF normal by MUGA, LV gated scan, or echocardiogram
Other:
- No other concurrent serious illness
- No other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Randomized Trial of Sequential Epirubicin and Docetaxel Versus Epirubicin in Node Positive Postmenopausal Breast Cancer Patients
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. Combining chemotherapy with hormone therapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of epirubicin and tamoxifen with or without docetaxel in treating postmenopausal women who have breast cancer that has spread to the lymph nodes.
Read the detailed description
OBJECTIVES:
- Compare the impact of adjuvant epirubicin with or without docetaxel and concurrent or sequential tamoxifen on time to relapse and overall survival in postmenopausal women with node-positive breast cancer.
- Compare the toxic effects of these regimens in this patient population.
- Compare the quality of life in terms of shift in long term toxicity and differences in recuperation in women treated with these regimens.
- Compare the incidence of thromboembolic events during the first 9 months of study and the influence of such events on compliance in women treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to one of two adjuvant chemotherapy treatment arms within 30 days after surgery.
- Arm I: Patients receive adjuvant epirubicin IV on days 1 and 8. Treatment continues every 28 days for 6 courses.
- Arm II: Patients receive adjuvant epirubicin IV on days 1 and 8. Treatment continues every 28 days for 3 courses. Patients then receive docetaxel IV over 1 hour on day 1. Treatment continues every 21 days for 3 courses.
Patients may be further randomized to one of two tamoxifen arms. Patients not randomized to the tamoxifen arms receive oral tamoxifen daily for 5 years concurrently with adjuvant chemotherapy.
- Arm I: Patients receive tamoxifen as above concurrently with adjuvant chemotherapy.
- Arm II: Patients receive sequential tamoxifen as above after completion of adjuvant chemotherapy.
Quality of life is assessed at baseline, 9 months, 2 years, and then at 5 years.
Patients are followed at 9 months, 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- docetaxel, epirubicin hydrochloride, tamoxifen citrate, adjuvant therapy
- Keywords
- stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC 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.
docetaxelDrug
epirubicin hydrochlorideDrug
tamoxifen citrateDrug
adjuvant therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Overall survival
Incidence of thromboembolic events during the first 9 months after randomization
Secondary outcomes (2)
Tolerability
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startAug 1997
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
Sponsor and investigators
- Lead sponsor
- International Collaborative Cancer Group
- Sponsor type
- University, hospital or other
- Investigators
- R. Charles Coombes, MD, MRCP, FRCP, PhD, FMedSci, Study chair, Hammersmith Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00010140
- Sponsor's protocol ID
- CDR0000068450
- Other IDs
- ICCG-C/14/96, EU-20040
- Status last verified
- Sep 2005
- First submitted
- 2 Feb 2001
- Last updated
- 18 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Trial of Sequential Epirubicin and Docetaxel Versus Epirubicin in Node Positive Postmenopausal Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00010140
- Acronym / sponsor ID
- CDR0000068450
- Conditions
- Breast Cancer
- Keywords
- stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- International Collaborative Cancer GroupUniversity, hospital or other
- Study start
- Aug 1997
- First posted
- 27 Jan 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. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. Combining chemotherapy with hormone therapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of epirubicin and tamoxifen with or without docetaxel in treating postmenopausal women who have breast cancer that has spread to the lymph nodes.
Detailed description
OBJECTIVES:
- Compare the impact of adjuvant epirubicin with or without docetaxel and concurrent or sequential tamoxifen on time to relapse and overall survival in postmenopausal women with node-positive breast cancer.
- Compare the toxic effects of these regimens in this patient population.
- Compare the quality of life in terms of shift in long term toxicity and differences in recuperation in women treated with these regimens.
- Compare the incidence of thromboembolic events during the first 9 months of study and the influence of such events on compliance in women treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to one of two adjuvant chemotherapy treatment arms within 30 days after surgery.
- Arm I: Patients receive adjuvant epirubicin IV on days 1 and 8. Treatment continues every 28 days for 6 courses.
- Arm II: Patients receive adjuvant epirubicin IV on days 1 and 8. Treatment continues every 28 days for 3 courses. Patients then receive docetaxel IV over 1 hour on day 1. Treatment continues every 21 days for 3 courses.
Patients may be further randomized to one of two tamoxifen arms. Patients not randomized to the tamoxifen arms receive oral tamoxifen daily for 5 years concurrently with adjuvant chemotherapy.
- Arm I: Patients receive tamoxifen as above concurrently with adjuvant chemotherapy.
- Arm II: Patients receive sequential tamoxifen as above after completion of adjuvant chemotherapy.
Quality of life is assessed at baseline, 9 months, 2 years, and then at 5 years.
Patients are followed at 9 months, 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| docetaxel | Drug | – |
| epirubicin hydrochloride | Drug | – |
| tamoxifen citrate | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
Primary outcome
Disease-free survival
Overall survival
Incidence of thromboembolic events during the first 9 months after randomization
2 secondary outcomes
Tolerability
Quality of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
Related trials for Breast Cancer
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.
R. Charles Coombes, MD, MRCP, FRCP, PhD, FMedSci study chair
Hammersmith Hospitals NHS Trust
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 docetaxel, epirubicin hydrochloride and tamoxifen citrate in people with Breast Cancer, run by International Collaborative Cancer Group at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2013. 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 United Kingdom. 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?
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?
Disease-free survival. The study lists 3 primary outcomes in all. 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 18 Dec 2013.