search
Back to results

Adjuvant Hormone Therapy in Treating Women With Operable Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
goserelin acetate
tamoxifen citrate
ablative endocrine surgery
oophorectomy
Sponsored by
Cancer Research UK
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage I breast cancer, stage II breast cancer, stage IIIA breast cancer

Eligibility Criteria

undefined - 49 Years (Child, Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Operable, clinical Stage I/II breast cancer (T1-3, N0-1, M0) No evidence of distant metastases on x-ray of chest, spine, and pelvis Bone scan evidence alone of secondary mass allowed unless considered unequivocal evidence of metastasis No primary carcinoma fixed to underlying muscle or chest wall No deeply fixed axillary nodes No ulceration, skin infiltration, or peau d'orange involving more than 1/3 of breast No bilateral tumors Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: Under 50 Sex: Women only Menopausal status: Any status Performance status: Not specified Life expectancy: No limits on life expectancy due to intercurrent illness Hematopoietic: WBC at least 3,000 Platelets at least 90,000 Hemoglobin at least 10 g/dL Hepatic: Normal liver function required Renal: Normal kidney function required Other: Fit for surgery No prior treatment for other malignancies except: Nonmelanomatous skin cancer Cone-biopsied in situ carcinoma of the cervix English-speaking patients eligible for quality-of-life assessments PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Chemotherapy for high-risk patients allowed at the discretion of the clinician Endocrine therapy: At least 6 weeks since prior hormonal therapy No concomitant hormonal therapy including oral contraceptives (patients must discontinue the pill for 2 years) Radiotherapy: Not specified Surgery: Not specified

Sites / Locations

  • Hopital De Braine-L'Alleud-Waterloo
  • Institut Jules Bordet
  • U.Z. Sint-Rafael
  • Royal Sussex County Hospital
  • Castle Hill Hospital
  • Walsgrave Hospital
  • Mayday University Hospital
  • Huddersfield Royal Infirmary
  • Cookridge Hospital
  • Whittington Hospital
  • Guy's, King's and St. Thomas' Hospitals Trust
  • Cancer Research Campaign Clinical Trials Unit-London
  • Royal Marsden NHS Trust
  • Middlesex Hospital- Meyerstein Institute
  • Clatterbridge Centre for Oncology NHS Trust
  • South Tees Acute Hospitals NHS Trust
  • Newcastle General Hospital
  • Derriford Hospital
  • Portsmouth Hospitals NHS Trust
  • Salisbury General Infirmary
  • Royal South Hants Hospital
  • Southampton General Hospital
  • North Tees General Hospital
  • North Staffs Royal Infirmary
  • Radiotherapy Department
  • Sunderland Royal Infirmary
  • Royal Marsden Hospital
  • Royal Hampshire County Hospital
  • Belfast City Hospital Trust
  • Belfast City Hospital Trust
  • Mid-Ulster Hospital
  • Ards General Hospital
  • Ninewells Hospital and Medical School
  • Velindre Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
August 6, 2013
Sponsor
Cancer Research UK
search

1. Study Identification

Unique Protocol Identification Number
NCT00002460
Brief Title
Adjuvant Hormone Therapy in Treating Women With Operable Breast Cancer
Official Title
Phase III Randomized Study of Adjuvant Therapy With Tamoxifen vs Endocrine Ablation vs Tamoxifen Plus Endocrine Ablation vs No Adjuvant Therapy in Patients Under Age 50 With Operable Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Unknown status
Study Start Date
September 1987 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Cancer Research UK

4. Oversight

5. Study Description

Brief 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. PURPOSE: Phase III trial to compare the effectiveness of adjuvant therapy using tamoxifen or ovarian ablation with goserelin or both in treating women with stage I or stage II breast cancer.
Detailed Description
OBJECTIVES: I. Determine, in a prospective, randomized, controlled trial whether the administration of a course of adjuvant tamoxifen or ablation of ovarian function results in prolongation of time to recurrence or death in patients under 50 years of age with operable carcinoma of the breast. II. Determine how hormone manipulation affects mood and sexual functioning in these patients. OUTLINE: This is a randomized study. Patients are stratified by clinician. All patients are randomized following primary therapy, which, in addition to surgery, may include local irradiation, perioperative cyclophosphamide, or up to 6 cycles of cyclophosphamide, methotrexate, and fluorouracil (CMF) for high-risk patients. Clinicians may elect to randomize patients to all groups or to only those groups including tamoxifen. The first group receives no further therapy. Then second group receives tamoxifen daily for at least 2 years. The third group receives ovarian ablation with goserelin via monthly injection for at least 2 years. The final group receives ovarian ablation with goserelin plus daily tamoxifen for at least 2 years. All patients are followed every 3 months for 2 years, every 6 months for 3 years, then annually. PROJECTED ACCRUAL: 800 to 1,000 patients will be entered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage I breast cancer, stage II breast cancer, stage IIIA breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
goserelin acetate
Intervention Type
Drug
Intervention Name(s)
tamoxifen citrate
Intervention Type
Procedure
Intervention Name(s)
ablative endocrine surgery
Intervention Type
Procedure
Intervention Name(s)
oophorectomy

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Operable, clinical Stage I/II breast cancer (T1-3, N0-1, M0) No evidence of distant metastases on x-ray of chest, spine, and pelvis Bone scan evidence alone of secondary mass allowed unless considered unequivocal evidence of metastasis No primary carcinoma fixed to underlying muscle or chest wall No deeply fixed axillary nodes No ulceration, skin infiltration, or peau d'orange involving more than 1/3 of breast No bilateral tumors Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: Under 50 Sex: Women only Menopausal status: Any status Performance status: Not specified Life expectancy: No limits on life expectancy due to intercurrent illness Hematopoietic: WBC at least 3,000 Platelets at least 90,000 Hemoglobin at least 10 g/dL Hepatic: Normal liver function required Renal: Normal kidney function required Other: Fit for surgery No prior treatment for other malignancies except: Nonmelanomatous skin cancer Cone-biopsied in situ carcinoma of the cervix English-speaking patients eligible for quality-of-life assessments PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Chemotherapy for high-risk patients allowed at the discretion of the clinician Endocrine therapy: At least 6 weeks since prior hormonal therapy No concomitant hormonal therapy including oral contraceptives (patients must discontinue the pill for 2 years) Radiotherapy: Not specified Surgery: Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Baum, MD, ChM, FRCS
Organizational Affiliation
University College London Hospitals
Official's Role
Study Chair
Facility Information:
Facility Name
Hopital De Braine-L'Alleud-Waterloo
City
Braine-L'Alleud
ZIP/Postal Code
1420
Country
Belgium
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
U.Z. Sint-Rafael
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Royal Sussex County Hospital
City
Brighton
State/Province
England
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Castle Hill Hospital
City
Cottingham
State/Province
England
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Walsgrave Hospital
City
Coventry
State/Province
England
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Mayday University Hospital
City
Croydon
State/Province
England
Country
United Kingdom
Facility Name
Huddersfield Royal Infirmary
City
Huddersfield, West Yorks
State/Province
England
ZIP/Postal Code
HD3 3EA
Country
United Kingdom
Facility Name
Cookridge Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS16 6QB
Country
United Kingdom
Facility Name
Whittington Hospital
City
London
State/Province
England
ZIP/Postal Code
N19 5NF
Country
United Kingdom
Facility Name
Guy's, King's and St. Thomas' Hospitals Trust
City
London
State/Province
England
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Cancer Research Campaign Clinical Trials Unit-London
City
London
State/Province
England
ZIP/Postal Code
SE5 9NU
Country
United Kingdom
Facility Name
Royal Marsden NHS Trust
City
London
State/Province
England
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Middlesex Hospital- Meyerstein Institute
City
London
State/Province
England
ZIP/Postal Code
W1N 8AA
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology NHS Trust
City
Merseyside
State/Province
England
ZIP/Postal Code
L63 4JY
Country
United Kingdom
Facility Name
South Tees Acute Hospitals NHS Trust
City
Middlesbrough, Cleveland
State/Province
England
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Newcastle General Hospital
City
Newcastle Upon Tyne
State/Province
England
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
State/Province
England
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Portsmouth Hospitals NHS Trust
City
Portsmouth
State/Province
England
ZIP/Postal Code
P03 6AD
Country
United Kingdom
Facility Name
Salisbury General Infirmary
City
Salisbury
State/Province
England
ZIP/Postal Code
SP2 7SX
Country
United Kingdom
Facility Name
Royal South Hants Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO14 0YG
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
North Tees General Hospital
City
Stockton-On-Tees
State/Province
England
ZIP/Postal Code
TS19 8PE
Country
United Kingdom
Facility Name
North Staffs Royal Infirmary
City
Stoke-On-Trent
State/Province
England
ZIP/Postal Code
ST4 7LN
Country
United Kingdom
Facility Name
Radiotherapy Department
City
Stratford-on-Avon, Warwickshire
State/Province
England
ZIP/Postal Code
CV37 6NX
Country
United Kingdom
Facility Name
Sunderland Royal Infirmary
City
Sunderland
State/Province
England
ZIP/Postal Code
SR2 7JE
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Royal Hampshire County Hospital
City
Winchester
State/Province
England
ZIP/Postal Code
SO22 5DG
Country
United Kingdom
Facility Name
Belfast City Hospital Trust
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT8 8JR
Country
United Kingdom
Facility Name
Belfast City Hospital Trust
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Mid-Ulster Hospital
City
Londonderry
State/Province
Northern Ireland
ZIP/Postal Code
BT45 5EX
Country
United Kingdom
Facility Name
Ards General Hospital
City
Newtownards
State/Province
Northern Ireland
Country
United Kingdom
Facility Name
Ninewells Hospital and Medical School
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Velindre Hospital
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF4 7XL
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Adjuvant Hormone Therapy in Treating Women With Operable Breast Cancer

We'll reach out to this number within 24 hrs