Search / Trial NCT00002582

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

Launched by INSTITUTE OF CANCER RESEARCH, UNITED KINGDOM · Jul 7, 2003

Trial Information

Current as of December 06, 2024

Completed

Keywords

Stage I Breast Cancer Stage Ii Breast Cancer Stage Iiia Breast Cancer

ClinConnect Summary

OBJECTIVES:

* Estimate overall and relapse-free survival of women with early-stage breast cancer receiving adjuvant tamoxifen with or without adjuvant chemotherapy and/or ovarian suppression.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating institution and choice of randomization option.

Postmenopausal women are randomized to the first or second groups.

Randomization for pre- and perimenopausal women is based on the clinician's judgement of appropriate adjuvant therapy (chemotherapy and/or ovarian suppression). Patients may be randomized as foll...

Gender

FEMALE

Eligibility criteria

  • 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

Trial Officials

John R. Yarnold, MD, FRCR

Study Chair

Royal Marsden NHS Foundation Trust

Helena Earl, MBBS, PhD, FRCP

Study Chair

Cancer Research Campaign Clinical Trials Centre

Stanley B. Kaye, MD, FRCP

Study Chair

University of Glasgow

Tim J. Perren, MD

Study Chair

Leeds Cancer Centre at St. James's University Hospital

About Institute Of Cancer Research, United Kingdom

The Institute of Cancer Research (ICR) in the United Kingdom is a leading cancer research organization dedicated to understanding the biology of cancer and developing innovative therapeutic strategies. Renowned for its pioneering contributions to cancer treatment and prevention, the ICR conducts cutting-edge clinical trials that translate laboratory discoveries into effective clinical applications. Collaborating with a network of academic, clinical, and industry partners, the ICR is committed to advancing cancer research and improving patient outcomes through rigorous scientific inquiry and a patient-centered approach.

Locations

Glasgow, Scotland, United Kingdom

Birmingham, England, United Kingdom

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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