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Zoladex Plus Tamoxifen in Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier:
NCT00827307
First received: January 21, 2009
Last updated: August 5, 2011
Last verified: August 2011
History of Changes
  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: tamoxifen
Drug: Goserelin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Adjuvant Zoladex Plus Tamoxifen on Breast Density in Pre- or Peri-menopausal Women With Early-stage Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

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
Study Completion Date: August 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: TAM

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

Locations
China, Zhejiang
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
Principal Investigator: Hong-Jian Yang, MD. Zhejiang Provicial Cancer Hospital
Principal Investigator: Xiang-Yun Zong, MD., PhD. Zhejiang Provincial Cancer Hospital
  More Information

No publications provided

Responsible Party: Yang Hong-Jian, Zong Xiang-Yun, Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT00827307     History of Changes
Other Study ID Numbers: D8666L00002
Study First Received: January 21, 2009
Last Updated: August 5, 2011
Health Authority: China: Ministry of Health

Keywords provided by Zhejiang Cancer Hospital:
breast carcinoma; goserelin; Mammographic density

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Goserelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on May 23, 2013