CClinicalTrials.gg
Sign In
Status unknownNCT00010140Updated Dec 18, 2013

Epirubicin and Tamoxifen With or Without Docetaxel in Treating Postmenopausal Women With Breast Cancer

A Phase 3 interventional study of docetaxel and epirubicin hydrochloride in Breast Cancer, sponsored by International Collaborative Cancer Group. Status unknown at 1 site in United Kingdom. Open to female participants. Per ClinicalTrials.gov, last updated 2013-12-18.

Sponsored by International Collaborative Cancer Group · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2005), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Allocation
Randomized
Sex
Female
01

Study 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.

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.

02

Conditions studied

  • Breast Cancer

Browse trials for

Keywords

  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

Browse Breast Neoplasms studies →

Lead sponsor

International Collaborative Cancer Group is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized

Interventions

  • Drugdocetaxel
  • Drugepirubicin hydrochloride
  • Drugtamoxifen citrate
  • Procedureadjuvant therapy
06

What researchers measure

Primary outcomes

  1. Disease-free survival

  2. Overall survival

  3. Incidence of thromboembolic events during the first 9 months after randomization

Secondary outcomes

  1. Tolerability

  2. Quality of life

07

Study locations

1 site
  • Charing Cross Hospital
    London, England W12 0NN, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00010140
Lead sponsor
International Collaborative Cancer Group
First posted
Jan 27, 2003
Start date
Aug 1997
Last update
Dec 18, 2013

Study contacts

R. Charles Coombes, MD, MRCP, FRCP, PhD, FMedSci
study chair · Hammersmith Hospitals NHS Trust
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Breast Neoplasms→

Other studies from this sponsor

International Collaborative Cancer Group

Start the discussion