Zoladex Plus Tamoxifen in Breast Cancer

NCT00827307 | Completed

• 1 other identifier: D8666L00002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 density, estrogen levels, lipidemia, endometrial thickness and ultrasonographic abnormalities.

Conditions

Mammography; Estrogen; Lipemia; Endometrium; Ultrasonography

Keywords

breast carcinoma; goserelin; Mammographic density

Outcome Measures

Primary Outcomes (1)

• Mammographic percentage density at 18months

  18months after enrolled

Secondary Outcomes (1)

• estrogen levels, lipidemia, endometrial thickness and ultrasonographic abnormalities

  3,6,12,18 months

Study Arms (2)

Combination

EXPERIMENTAL

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.

Drug: Goserelin

Conctrol

ACTIVE COMPARATOR

In the monotherapy arm, patients receive once-daily oral dose of tamoxifen 20 mg.

Drug: tamoxifen

Interventions

tamoxifen DRUG

In the monotherapy arm, patients receive once-daily oral dose of tamoxifen 20 mg.

Also known as: TAM

Conctrol

Goserelin DRUG

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

Also known as: ZOLADEX

Combination

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Related Publications (1)

• Yang 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 DERIVED

MeSH Terms

Conditions

Hyperlipidemias; Breast Neoplasms

Interventions

Tamoxifen; Goserelin

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Hong-Jian Yang, MD.

  Zhejiang Provicial Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Xiang-Yun Zong, MD., PhD.

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 21, 2009
• First Posted: January 22, 2009
• Study Start: June 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 8, 2011

Record last verified: 2011-08

Locations

CN (1)