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A Randomized Phase III Study Comparing Cyclophosphamide + Methotrexate + Fluorouracil Vs. Goserelin + Tamoxifen in Premenopausal, Hormone Receptor-Positive, Lymph Node-Positive or -Negative Patients


Phase 3
19 Years
N/A
Not Enrolling
Female
Early-Stage Breast Cancer

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Trial Information

A Randomized Phase III Study Comparing Cyclophosphamide + Methotrexate + Fluorouracil Vs. Goserelin + Tamoxifen in Premenopausal, Hormone Receptor-Positive, Lymph Node-Positive or -Negative Patients


Inclusion Criteria:



- Premenopausal patients with histologically verified, lymph node-negative (pT1c-pT3)
or lymph node-positive (pT1a-pT3) breast cancer

- Hormone receptor-positive status

- More than 6 histologically examined lymph nodes

- Laboratory parameters

1. hematopoiesis: > 3500/l leukocytes, > 100,000/l thrombocytes

2. renal function: creatinin < 1.5mg%

3. hepatic function: GOT
4. bilirubin: < 1.5mg %

5. metabolic parameters: Na, Ca, K in normal range, normal level of blood sugar

6. blood coagulation: PZ > 60%

- Concluded healing process following surgery

-
- Informed consent

Exclusion Criteria:

- T4 carcinoma; inflammatory breast cancer, carcinoma in situ

- Simultaneous or sequential bilateral breast cancer

- Preoperative tumor-reducing radiotherapy or preoperative tumor-specific medical
treatment

- Male patients

- Pregnancy or lactation

- Lacking compliance or understanding of the disease

- General contraindication against cytostatic treatment

- Serious concomitant disease preventing implementation of adjuvant therapy or regular
follow-up

- Second carcinoma or status post second carcinoma (except for curatively treated
squamous cell carcinoma of the skin or cervical carcinoma in situ)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Principal Investigator

Raimund Jakesz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Austrian Breast & Colorectal Cancer Study Group

Authority:

Austria: Federal Ministry for Health and Women

Study ID:

ABCSG-5

NCT ID:

NCT00309478

Start Date:

December 1990

Completion Date:

Related Keywords:

  • Early-Stage Breast Cancer
  • Cyclophosphamide
  • Methotrexate
  • Fluorouracil
  • Goserelin
  • Tamoxifen
  • Breast cancer
  • Breast Neoplasms

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