Zoladex Plus Tamoxifen in Breast Cancer

August 5, 2011 updated by: Zhejiang Cancer Hospital

The Effects of Adjuvant Zoladex Plus Tamoxifen on Breast Density in Pre- or Peri-menopausal Women With Early-stage Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combination
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
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
Other Names:
  • ZOLADEX
Active Comparator: Conctrol
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.
Other Names:
  • TAM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mammographic percentage density at 18months
Time Frame: 18months after enrolled
18months after enrolled

Secondary Outcome Measures

Outcome Measure
Time Frame
estrogen levels, lipidemia, endometrial thickness and ultrasonographic abnormalities
Time Frame: 3,6,12,18 months
3,6,12,18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Cancer Hospital

Investigators

  • Principal Investigator: Hong-Jian Yang, MD., Zhejiang Provicial Cancer Hospital
  • Principal Investigator: Xiang-Yun Zong, MD., PhD., Zhejiang Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

January 21, 2009

First Submitted That Met QC Criteria

January 21, 2009

First Posted (Estimate)

January 22, 2009

Study Record Updates

Last Update Posted (Estimate)

August 8, 2011

Last Update Submitted That Met QC Criteria

August 5, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8666L00002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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