Status:
COMPLETED
Zoladex Plus Tamoxifen in Breast Cancer
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
Mammography
Estrogen
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
The purpose of this study is to compare Zoladex plus tamoxifen with tamoxifen alone as adjuvant hormonal therapy in pre- or perimenopausal women with early-stage breast cancer in terms of breast densi...
Detailed Description
After the completion of primary treatment(surgery and/or adjuvant chemotherapy, radiotherapy could be given concurrently with study medication), eligible patients will be randomized to receive Zoladex...
Eligibility Criteria
Inclusion
- provision of informed consent
- histologically proven HR+ operable invasive breast cancer
- completion of surgery and chemotherapy(if given).
- women defined as pre- or perimenopausal according to all of the following: aged 50 years or younger, at least one menstrual period during the last months.
Exclusion
- clinical evidence of metastatic disease
- pregnancy or breast-feeding
- bilateral oophorectomy;
- radiation of the ovaries
- patients who, for whatever reason(eg, confusion, infirmity,alcoholism),are unlikely to comply with trial requirements
- patients whose chemotherapy was started more than 8 weeks after completion of primary surgery or whose chemotherapy was completed more than 8 weeks before starting the study treatment. Chemotherapy, if given, should have been given post-operatively, ie, patients who received neoadjuvant chemotherapy are ineligible
- patients who have not received chemotherapy and whose primary surgery was completed more than 8 weeks before starting the study treatment
- previous hormonal therapy as adjuvant treatment for breast cancer
- patients unwilling to stop taking any drug known to affect sex hormonal status, or in whom it would be inappropriate to stop
- previous history of invasive malignancy within the last 5 years, other than squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied
- treatment with a non-approved or experimental drug during 1 month before entry into the study
- history of hypersensitivity to active or inactive excipients of tamoxifen and Zoladex
- history of bleeding diathesis (ie. Disseminated intravascular coagulation, clotting factor deficiency), or long term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin )
- leukopenia and/or thrombocytopenia
- history of ocular fundus diseases
- history of thromboembolic diseases
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00827307
Start Date
June 1 2008
End Date
August 1 2011
Last Update
August 8 2011
Active Locations (1)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022