Zoladex Plus Tamoxifen in Breast Cancer - Full Text View

Sponsored by:	Zhejiang Cancer Hospital
Information provided by:	Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier:	NCT00827307

Purpose

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.

Condition	Intervention
Mammography Estrogen Lipemia Endometrium Ultrasonography	Drug: ZOLADEX plus tamoxifen Drug: tamoxifen

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Mammography Ultrasound

Drug Information available for: Tamoxifen Tamoxifen citrate Goserelin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	The Effects of Adjuvant Zoladex Plus Tamoxifen on Breast Density in Pre- or Peri-Menopausal Women With Early-Stage Breast Cancer

Further study details as provided by Zhejiang Cancer Hospital:

Primary Outcome Measures:

Mammographic percentage density at 18months [ Time Frame: 18months after enrolled ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

estrogen levels, lipidemia, endometrial thickness and ultrasonographic abnormalities [ Time Frame: 3,6,12,18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: 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: ZOLADEX plus tamoxifen 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
B: Active Comparator In the monotherapy arm, patients receive once-daily oral dose of tamoxifen 20 mg.	Drug: tamoxifen In the monotherapy arm, patients receive once-daily oral dose of tamoxifen 20 mg.

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 plus tamoxifen or tamoxifen alone. The duration of study medication along with the follow-up will be 18 months, or until disease recurrence,or discontinuation of study therapy (as a result of an adverse event, a patient's request, or an investigator's decision), further treatment will be at investigator's discretion. During the study period, contralateral mammograms and transvaginal ultrasound will be undertaken at baseline and after 6, 12 and 18 months of study medications. Mammographic density assessment will be undertaken by a single radiologist. Serum measurements including estrogen levels and lipidemia will be obtained at baseline and after 3, 6, 12 and 18 months of study medications.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827307

Contacts

Contact: Yang Hong-Jian, MD	0086-571-88122058	yhjzlyy@hotmail.com
Contact: Zong Xiang-Yun, MD	0086-571-88122052	tigerzong@msn.com

Locations

China, Zhejiang
Zhejiang Cancer Hospital	Recruiting
Hangzhou, Zhejiang, China, 310022
Principal Investigator: Yang Hong-Jian, MD

Sponsors and Collaborators

Zhejiang Cancer Hospital

Investigators

Principal Investigator:

YANG Hongjian, MD

Zhejiang provicial cancer hospital

More Information

No publications provided

Responsible Party:	Zhejiang Cancer Hospital ( Yang Hong-Jian, Zong Xiang-Yun )
Study ID Numbers:	D8666L00002
Study First Received:	January 21, 2009
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00827307 History of Changes
Health Authority:	China: Ministry of Health

Keywords provided by Zhejiang Cancer Hospital:

breast carcinoma; goserelin; Mammographic density

Study placed in the following topic categories:

Estrogen Antagonists
Estrogens
Hyperlipidemias
Skin Diseases
Antineoplastic Agents, Hormonal
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Goserelin
Adjuvants, Immunologic

Breast Neoplasms
Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
Hormones
Tamoxifen
Carcinoma
Estrogen Receptor Modulators
Breast Diseases
Menopause

Additional relevant MeSH terms:

Estrogen Antagonists
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Goserelin
Breast Neoplasms

Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
Tamoxifen
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Breast Diseases

ClinicalTrials.gov processed this record on May 06, 2009