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Octreotide with Tamoxifen and Chemotherapy in Early Breast Cancer
NCT00002967Phase 3
Key facts
- Status
- Completed
- Start
- May 1997
- Countries
- 2
- Sponsor
- NSABP Foundation
- Modality
- Peptides
- Drugs
- octreotide
- Conditions
- breast cancer
01
Overview
Phase 3, randomised, open-label trial of octreotide in breast cancer (4 arms), sponsored by NSABP Foundation. Primary endpoint: Disease Free Survival. Started May 1997; status: completed.
02
Design
4 arms- Study design
- RandomizedOpen-label
Tamoxifen
Tamoxifen 5 years
Tamoxifen + Octreotide
Tamoxifen 5 years + Octreotide 2 years
Tamoxifen + Chemo
AC Chemo x4 + Tamoxifen 5 years
Tamoxifen + Chemo + Octreotide
AC Chemo x4 + Tamoxifen 5 years + Octreotide 2 years
03
Who it enrols
Women with histologically confirmed Stage I or II invasive adenocarcinoma of the breast, ER-positive, and axillary node-negative (pN0). Must have undergone mastectomy or lumpectomy with clear margins. No prior systemic therapy for breast cancer.
04
Endpoints
Primary
Disease Free Survival
Secondary
Rate of Endometrial Cancer
Rate of Opposite Breast Cancer
Incidence of Gallstone Formation
Incidence of Hyper and Hypoglycemia
Incidence of Hypothyroidism
Incidence of Vitamin B12 Deficiency
Overall Survival
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