Clinical trial · Interventional
Zoladex Plus Tamoxifen in Breast Cancer
The Effects of Adjuvant Zoladex Plus Tamoxifen on Breast Density in Pre- or Peri-menopausal Women With Early-stage Breast Cancer
NCT00827307CI-TRIAL-00005336completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 density, estrogen levels, lipidemia, endometrial thickness and ultrasonographic abnormalities.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrium | — | UNRESOLVED | — |
| Estrogen | — | UNRESOLVED | — |
| Lipemia | — | UNRESOLVED | — |
| Mammography | — | UNRESOLVED | — |
| Ultrasonography | — | UNRESOLVED | — |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Combination
- description
- In the combination arm, patients receive ZOLADEX 3.6 mg by subcutaneous injection every 4 weeks along with once-daily oral dose of tamoxifen 20 mg.
- interventionNames
- Drug: Goserelin
- type
- ACTIVE_COMPARATOR
- label
- Conctrol
- description
- In the monotherapy arm, patients receive once-daily oral dose of tamoxifen 20 mg.
- interventionNames
- Drug: tamoxifen
Primary outcomes (1)
- measure
- Mammographic percentage density at 18months
- timeFrame
- 18months after enrolled
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (1)
- DERIVEDYang H, Zong X, Yu Y, Shao G, Zhang L, Qian C, Bian Y, Xu X, Sun W, Meng X, Ding X, Chen D, Zou D, Xie S, Zheng Y, Zhang J, He X, Sun C, Yu X, Ni J. Combined effects of goserelin and tamoxifen on estradiol level, breast density, and endometrial thickness in premenopausal and perimenopausal women with early-stage hormone receptor-positive breast cancer: a randomised controlled clinical trial. Br J Cancer. 2013 Aug 6;109(3):582-8. doi: 10.1038/bjc.2013.324. Epub 2013 Jul 16. PMID 23860520