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

NCT00002582 | Completed Phase 3

• 7 other identifiers: NCRI-ABCCDR0000063697CRC-TU-BR3010SCTN-BR9401/BR9402YRCO-ABCEU-94029UKCCCR-ABC
• Study Type: interventional
• Target: 6,000
• Locations: 1 country
• Sites: 2

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. Combination chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with or without chemotherapy and/or ovarian ablation in treating 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

CMF regimen DRUG

cyclophosphamide DRUG

doxorubicin hydrochloride DRUG

fluorouracil DRUG

goserelin acetate DRUG

leuprolide acetate DRUG

methotrexate DRUG

tamoxifen citrate DRUG

oophorectomy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed invasive carcinoma of the breast for which adjuvant systemic therapy is appropriate * Stage I, II, or IIIA * Pathologically positive or negative nodes * Any size primary tumor * No edema, peau d'orange, infiltration of the skin, or direct extension to the chest wall * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * Not specified Sex: * Female Menopausal status: * Pre-, peri-, or postmenopausal Performance status: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No prior malignancy except: * Basal cell carcinoma * Carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics Chemotherapy: * See Disease Characteristics Endocrine therapy: * See Disease Characteristics Radiotherapy: * Not specified Surgery: * Not specified Other: * No prior systemic treatment for breast cancer

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

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead
• Cancer Research Campaign Clinical Trials Centre: collaborator
• Scottish Cancer Therapy Network: collaborator
• Yorkshire Regional Clinical Trials Research Unit: collaborator

Study Sites (2)

Cancer Research Campaign Trials Unit-Birmingham (CRCTU)

Birmingham, England, B15 2TT, United Kingdom

Location

Beatson Oncology Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Related Publications (6)

• Perren TJ. Adjuvant therapy for operable breast cancer; more answers, new questions. Br J Cancer. 1995 Jun;71(6):1142-4. doi: 10.1038/bjc.1995.223. No abstract available.

  PMID: 7779702 BACKGROUND

• Brunt AM. The UKCCCR adjuvant breast cancer (ABC) trial. ABC Trial Steering Committee. Clin Oncol (R Coll Radiol). 1994;6(4):209-10. doi: 10.1016/s0936-6555(05)80287-0. No abstract available.

  PMID: 7986756 BACKGROUND

• Yarnold JR, Bliss JM, Brunt M, Earl H, Kaye S, Mason M, Mossman J, Perren T, Richards M. Management of breast cancer. Refer women to multidisciplinary breast clinics. BMJ. 1994 Mar 12;308(6930):714-5. doi: 10.1136/bmj.308.6930.714a. No abstract available.

  PMID: 8142803 BACKGROUND

• Bliss JM, Yarnold JR. Treatment of early breast cancer. Lancet. 1992 Apr 11;339(8798):936. doi: 10.1016/0140-6736(92)90981-8. No abstract available.

  PMID: 1348335 BACKGROUND

• Adjuvant Breast Cancer Trials Collaborative Group. Polychemotherapy for early breast cancer: results from the international adjuvant breast cancer chemotherapy randomized trial. J Natl Cancer Inst. 2007 Apr 4;99(7):506-15. doi: 10.1093/jnci/djk108.

  PMID: 17405995 RESULT

• Adjuvant Breast Cancer Trials Collaborative Group. Ovarian ablation or suppression in premenopausal early breast cancer: results from the international adjuvant breast cancer ovarian ablation or suppression randomized trial. J Natl Cancer Inst. 2007 Apr 4;99(7):516-25. doi: 10.1093/jnci/djk109.

  PMID: 17405996 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CMF regimen; Cyclophosphamide; Doxorubicin; Fluorouracil; Goserelin; Leuprolide; Methotrexate; Tamoxifen; 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; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; 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; Castration; Endocrine Surgical Procedures; Surgical Procedures, Operative; Urogenital Surgical Procedures; Gynecologic Surgical Procedures; Therapeutics

Study Officials

• John R. Yarnold, MD, FRCR

  Royal Marsden NHS Foundation Trust

  STUDY CHAIR

• Helena Earl, MBBS, PhD, FRCP

  Cancer Research Campaign Clinical Trials Centre

  STUDY CHAIR

• Stanley B. Kaye, MD, FRCP

  University of Glasgow

  STUDY CHAIR

• Tim J. Perren, MD

  Leeds Cancer Centre at St. James's University Hospital

  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: July 8, 2003
• Study Start: June 1, 1993
• Study Completion: April 1, 2007
• Last Updated: August 2, 2013

Record last verified: 2007-05

Locations

GB (2)