Breast CancerPhase 3NCT00002580
Tamoxifen, Ovarian Ablation, and/or Combination Chemotherapy in Treating Premenopausal Women With Stage I, Stage II, or Stage IIIA Invasive Breast Cancer
A Phase 3 study testing cyclophosphamide, fluorouracil and goserelin acetate in people with Breast Cancer, run by Scottish Cancer Therapy Network at 10 sites in United Kingdom.
Trial summary
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study
- Who is it for?
- Ages Up to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- cyclophosphamide, fluorouracil and goserelin acetate
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 10 sitesUnited Kingdom
- Study dates
- Jun 1993to 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 Up to 70 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven unilateral, invasive breast cancer Stage T0-3, N0-1, M0 No carcinoma in situ alone, including Paget's disease of the nipple without underlying invasion No evidence of distant disease, including ipsilateral supraclavicular node enlargement unless proven benign No history of pure carcinoma in situ in either breast Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 70 and under Sex: Female Menopausal status: Premenopausal, defined by 1 of the following criteria: Last menstrual period less than 1 year before surgery Under age 50 with prior hysterectomy (for nonmalignant reason) without bilateral oophorectomy Under age 50 and on continuous oral contraception If at variance with the above definitions, hormonal assays in the premenopausal range take precedence Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing No other serious illness No other prior invasive malignancy except adequately treated basal cell or squamous cell skin cancer
PRIOR CONCURRENT THERAPY: Not specified
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United Kingdom10 sites
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
Ayr Hospital
Ayr, KA6 6DX
Ninewells Hospital and Medical School
Dundee, Scotland, DD1 9SY
Western General Hospital
Edinburgh, Scotland, EH4 9NQ
Falkirk Royal Infirmary
Falkirk, FK1 5RE
Beatson Oncology Centre
Glasgow, Scotland, G11 6NT
University of Glasgow
Glasgow, Scotland, G61 1BD
Raigmore Hospital
Inverness, Scotland, 1V2 3UJ
University Hospitals of Leicester
Leicester, England, LE1 5WW
Royal Alexandra Hospital
Paisley, Scotland
About this study
Official title: PROTOCOL FOR THE SCOTTISH PREMENOPAUSAL CHEMO-ENDOCRINE TRIAL
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with hormone therapy may kill more tumor cells. It is not yet known which treatment regimen is most effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with that of ovarian ablation, and/or combination chemotherapy in treating premenopausal women with stage I, stage II, or stage IIIA breast cancer.
Read the detailed description
OBJECTIVES: I. Compare the potential benefits of adjuvant tamoxifen with or without ovarian suppression and/or cyclophosphamide, methotrexate, and fluorouracil (CMF) in premenopausal women with stage I-IIIA, unilateral, invasive breast cancer.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to nodal status (positive vs negative or unknown) and hospital region. Patients undergo surgical resection with or without local radiotherapy, as appropriate. Radiotherapy begins within 8 weeks after surgery for patients randomized to arm I or III and within 4 weeks after completion of chemotherapy for patients randomized to arm II or IV. Patients are randomized to 1 of 4 treatment arms, preferably within 2 weeks after surgery. Arm I: Beginning within 4 weeks after surgery, patients receive oral tamoxifen daily. Treatment continues for 5 years in the absence of disease progression or unacceptable toxicity. Arm II: Beginning within 4 weeks after surgery, patients receive tamoxifen as in arm I and cyclophosphamide IV, methotrexate IV, and fluorouracil IV (CMF) on day 1. Chemotherapy continues every 3 weeks for 6 courses. Arm III: Beginning within 4 weeks after surgery, patients receive tamoxifen as in arm I and 1 of 3 ovarian suppression regimens, preferably regimen A. Regimen B is the preferred alternative to regimen A. Regimen A: Patients undergo oophorectomy. Regimen B: Patients undergo radiation-induced menopause comprising radiotherapy to the pelvis on days 1-4. Regimen C: Beginning 4 weeks after surgery, patients receive goserelin subcutaneously (SC) or leuprolide SC or intramuscularly on day 1. Treatment continues every 4 weeks for 2 years. Arm IV: Patients receive tamoxifen as in arm I and CMF as in arm II followed within 4 weeks by ovarian suppression as in arm III. Patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- cyclophosphamide, fluorouracil, goserelin acetate, leuprolide acetate, methotrexate
- Keywords
- 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.
cyclophosphamideDrug
fluorouracilDrug
goserelin acetateDrug
leuprolide acetateDrug
methotrexateDrug
tamoxifen citrateDrug
conventional surgeryProcedure or surgery
laparoscopic surgeryProcedure or surgery
oophorectomyProcedure or surgery
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2004 (estimated)
- Study startJun 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scottish Cancer Therapy Network
- Sponsor type
- University, hospital or other
- Investigators
- W.D. George, MD, MS, FRCS, Study chair, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002580
- Sponsor's protocol ID
- CDR0000063695
- Other IDs
- SCTN-BR9401, EU-94002, UKCCCR-ABC/BR9401
- Status last verified
- May 2007
- First submitted
- 1 Nov 1999
- Last updated
- 6 Nov 2013
- Results posted
- No
Publications
Featherstone C, Harnett AN, Brunt AM. Ultrasound localization of the ovaries for radiation-induced ovarian ablation. Clin Oncol (R Coll Radiol). 1999;11(6):393-7. doi: 10.1053/clon.1999.9090.
PubMed 10663329
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROTOCOL FOR THE SCOTTISH PREMENOPAUSAL CHEMO-ENDOCRINE TRIAL
- ClinicalTrials.gov ID
- NCT00002580
- Acronym / sponsor ID
- CDR0000063695
- Conditions
- Breast Cancer
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Scottish Cancer Therapy NetworkUniversity, hospital or other
- Study start
- Jun 1993
- First posted
- 11 Mar 2004 (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: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with hormone therapy may kill more tumor cells. It is not yet known which treatment regimen is most effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with that of ovarian ablation, and/or combination chemotherapy in treating premenopausal women with stage I, stage II, or stage IIIA breast cancer.
Detailed description
OBJECTIVES: I. Compare the potential benefits of adjuvant tamoxifen with or without ovarian suppression and/or cyclophosphamide, methotrexate, and fluorouracil (CMF) in premenopausal women with stage I-IIIA, unilateral, invasive breast cancer.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to nodal status (positive vs negative or unknown) and hospital region. Patients undergo surgical resection with or without local radiotherapy, as appropriate. Radiotherapy begins within 8 weeks after surgery for patients randomized to arm I or III and within 4 weeks after completion of chemotherapy for patients randomized to arm II or IV. Patients are randomized to 1 of 4 treatment arms, preferably within 2 weeks after surgery. Arm I: Beginning within 4 weeks after surgery, patients receive oral tamoxifen daily. Treatment continues for 5 years in the absence of disease progression or unacceptable toxicity. Arm II: Beginning within 4 weeks after surgery, patients receive tamoxifen as in arm I and cyclophosphamide IV, methotrexate IV, and fluorouracil IV (CMF) on day 1. Chemotherapy continues every 3 weeks for 6 courses. Arm III: Beginning within 4 weeks after surgery, patients receive tamoxifen as in arm I and 1 of 3 ovarian suppression regimens, preferably regimen A. Regimen B is the preferred alternative to regimen A. Regimen A: Patients undergo oophorectomy. Regimen B: Patients undergo radiation-induced menopause comprising radiotherapy to the pelvis on days 1-4. Regimen C: Beginning 4 weeks after surgery, patients receive goserelin subcutaneously (SC) or leuprolide SC or intramuscularly on day 1. Treatment continues every 4 weeks for 2 years. Arm IV: Patients receive tamoxifen as in arm I and CMF as in arm II followed within 4 weeks by ovarian suppression as in arm III. Patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- Up to 70 years
- 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 |
|---|---|---|
| cyclophosphamide | Drug | – |
| fluorouracil | Drug | – |
| goserelin acetate | Drug | – |
| leuprolide acetate | Drug | – |
| methotrexate | Drug | – |
| tamoxifen citrate | Drug | – |
| conventional surgery | Procedure or surgery | – |
| laparoscopic surgery | Procedure or surgery | – |
| oophorectomy | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
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 6 Nov 2013.
- Results publication: PubMed 10663329Featherstone C, Harnett AN, Brunt AM. Ultrasound localization of the ovaries for radiation-induced ovarian ablation. Clin Oncol (R Coll Radiol). 1999;11(6):393-7. doi: 10.1053/clon.1999.9090.
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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.
W.D. George, MD, MS, FRCS study chair
University of Glasgow
10 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 cyclophosphamide, fluorouracil and goserelin acetate in people with Breast Cancer, run by Scottish Cancer Therapy Network at 10 sites in United Kingdom.
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: finished, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002580, which also lists 1 linked publication.
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 6 Nov 2013.