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Zoladex Plus Tamoxifen in Breast Cancer

Primary Purpose

Mammography, Estrogen, Lipemia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
tamoxifen
Goserelin
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mammography focused on measuring breast carcinoma; goserelin; Mammographic density

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Zhejiang Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combination

Conctrol

Arm 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.

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

Outcomes

Primary Outcome Measures

Mammographic percentage density at 18months

Secondary Outcome Measures

estrogen levels, lipidemia, endometrial thickness and ultrasonographic abnormalities

Full Information

First Posted
January 21, 2009
Last Updated
August 5, 2011
Sponsor
Zhejiang Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00827307
Brief Title
Zoladex Plus Tamoxifen in Breast Cancer
Official Title
The Effects of Adjuvant Zoladex Plus Tamoxifen on Breast Density in Pre- or Peri-menopausal Women With Early-stage Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Zhejiang Cancer Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mammography, Estrogen, Lipemia, Endometrium, Ultrasonography
Keywords
breast carcinoma; goserelin; Mammographic density

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combination
Arm Type
Experimental
Arm 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.
Arm Title
Conctrol
Arm Type
Active Comparator
Arm Description
In the monotherapy arm, patients receive once-daily oral dose of tamoxifen 20 mg.
Intervention Type
Drug
Intervention Name(s)
tamoxifen
Other Intervention Name(s)
TAM
Intervention Description
In the monotherapy arm, patients receive once-daily oral dose of tamoxifen 20 mg.
Intervention Type
Drug
Intervention Name(s)
Goserelin
Other Intervention Name(s)
ZOLADEX
Intervention 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
Primary Outcome Measure Information:
Title
Mammographic percentage density at 18months
Time Frame
18months after enrolled
Secondary Outcome Measure Information:
Title
estrogen levels, lipidemia, endometrial thickness and ultrasonographic abnormalities
Time Frame
3,6,12,18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong-Jian Yang, MD.
Organizational Affiliation
Zhejiang Provicial Cancer Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiang-Yun Zong, MD., PhD.
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
23860520
Citation
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.
Results Reference
derived

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Zoladex Plus Tamoxifen in Breast Cancer

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