Search / Trial NCT00002529

Hormone Therapy and Chemotherapy in Treating Perimenopausal or Postmenopausal Women With Node-Positive Breast Cancer

Launched by ETOP IBCSG PARTNERS FOUNDATION · Jul 28, 2004

Trial Information

Current as of December 07, 2024

Completed

Keywords

Stage Ii Breast Cancer Stage Iiia Breast Cancer

ClinConnect Summary

OBJECTIVES: I. Compare overall survival and local and systemic disease-free survival produced by adjuvant chemoendocrine therapy with 4 courses of anthracycline/cyclophosphamide and concurrent vs. sequential tamoxifen (TMX) or toremifene (TOR) in peri- and postmenopausal women with node-positive breast cancer who are considered suitable for endocrine therapy alone. II. Evaluate these same endpoints in patients randomized to chemoendocrine therapy vs. endocrine therapy alone. III. Evaluate these same endpoints in patients randomized to TMX vs. TOR as the endocrine therapy agent. IV. Compare ...

Gender

FEMALE

Eligibility criteria

  • DISEASE CHARACTERISTICS: Histologically proven stage T1-3, pN1, M0 carcinoma of the breast considered suitable for adjuvant treatment with endocrine therapy alone Estrogen receptor at least 10 fmol/mg cytosol protein or positive on immunohistochemical assay Potentially curative resection within 6 weeks of entry by one of the following: Total mastectomy with negative margins Breast-conserving procedure (lumpectomy or quadrantectomy) for tumors less than 5 cm Adequate re-resection or mastectomy within 4 weeks of initial surgery required if margins are positive after initial surgery Axillary clearance (not sampling) required at surgery, with at least 1 node positive upon histopathologic examination of at least 8 nodes Suspicious manifestations of metastatic disease (e.g., hot spots on bone scan, skeletal pain of unknown cause) must be proven benign No bilateral breast cancer Any mass in contralateral breast must be proven benign by biopsy
  • PATIENT CHARACTERISTICS: Age: 70 and under Sex: Women only Menopausal status: Peri/postmenopausal, i.e.: More than 6 months since last normal menstrual period (LNMP) with no prior hysterectomy and no hormone replacement therapy (HRT) Prior hysterectomy and no HRT and either age greater than 55 or age 55 or less with postmenopausal LH, FSH, and E2 levels On HRT and either age 50 or greater or LNMP more than 6 months prior to starting HRT Performance status: Not specified Hematopoietic: WBC greater than 4,000 Platelets greater than 100,000 Hepatic: Bilirubin less than 1.1 mg/dL (20 micromoles/L) AST less than 60 IU/L Renal: Creatinine less than 1.3 mg/dL (120 micromoles/L) Other: No nonmalignant systemic disease that would preclude protocol therapy or prolonged follow-up No psychiatric or addictive disorder that would preclude informed consent No prior or concurrent second malignancy except: Nonmelanomatous skin cancer Adequately treated in situ carcinoma of the cervix Geographically accessible for follow-up
  • PRIOR CONCURRENT THERAPY: No prior therapy for breast cancer other than potentially curative surgery (see Disease Characteristics)

Trial Officials

Edda Simoncini, MD

Study Chair

Spedali Civili di Brescia

About Etop Ibcsg Partners Foundation

The Etop IBCSG Partners Foundation is a collaborative organization dedicated to advancing cancer research and improving treatment outcomes through innovative clinical trials. Focused on breast cancer and other malignancies, the foundation brings together a network of international partners, including academic institutions, healthcare providers, and industry stakeholders. By fostering multidisciplinary collaboration and leveraging cutting-edge methodologies, the Etop IBCSG Partners Foundation aims to facilitate the development of new therapeutic strategies, enhance patient care, and contribute to the global body of knowledge in oncology.

Locations

Aviano, , Italy

Ljubljana, , Slovenia

Bern, , Switzerland

Zurich, , Switzerland

Lausanne, , Switzerland

Sydney, New South Wales, Australia

Adelaide, South Australia, Australia

Perth, Western Australia, Australia

Rimini, , Italy

Rome, , Italy

Auckland, , New Zealand

Cape Town, , South Africa

Gothenburg (Goteborg), , Sweden

Basel, , Switzerland

Newcastle, New South Wales, Australia

Carlton South, Victoria, Australia

Brescia, , Italy

Milano, , Italy

Neuchatel, , Switzerland

Saint Gallen, , Switzerland

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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