Tamoxifen, Ovarian Ablation, and/or Combination Chemotherapy in Treating Premenopausal Women With Stage I, Stage II, or Stage IIIA Invasive Breast Cancer

NCT00002580 | Completed Phase 3

• 4 other identifiers: CDR0000063695SCTN-BR9401EU-94002UKCCCR-ABC/BR9401
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 10

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. 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.

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer; stage IIIA breast cancer

Interventions

cyclophosphamide DRUG

fluorouracil DRUG

goserelin acetate DRUG

leuprolide acetate DRUG

methotrexate DRUG

tamoxifen citrate DRUG

conventional surgery PROCEDURE

laparoscopic surgery PROCEDURE

oophorectomy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: Up to 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Scottish Cancer Therapy Network: lead

Study Sites (10)

University Hospitals of Leicester

Leicester, England, LE1 5WW, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Ninewells Hospital and Medical School

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Western General Hospital

Edinburgh, Scotland, EH4 9NQ, United Kingdom

Location

Beatson Oncology Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

University of Glasgow

Glasgow, Scotland, G61 1BD, United Kingdom

Location

Raigmore Hospital

Inverness, Scotland, 1V2 3UJ, United Kingdom

Location

Royal Alexandra Hospital

Paisley, Scotland, United Kingdom

Location

Ayr Hospital

Ayr, KA6 6DX, United Kingdom

Location

Falkirk Royal Infirmary

Falkirk, FK1 5RE, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 10663329 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cyclophosphamide; Fluorouracil; Goserelin; Leuprolide; Methotrexate; Tamoxifen; Laparoscopy; Ovariectomy; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Castration; Endocrine Surgical Procedures; Urogenital Surgical Procedures; Gynecologic Surgical Procedures; Therapeutics

Study Officials

• W.D. George, MD, MS, FRCS

  University of Glasgow

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: March 11, 2004
• Study Start: June 1, 1993
• Last Updated: November 6, 2013

Record last verified: 2007-05

Locations

GB (10)