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

18 Years
50 Years
Not Enrolling
Mammography, Estrogen, Lipemia, Endometrium, Ultrasonography

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Trial Information

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

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Mammographic percentage density at 18months

Outcome Time Frame:

18months after enrolled

Safety Issue:


Principal Investigator

Hong-Jian Yang, MD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Zhejiang Provicial Cancer Hospital


China: Ministry of Health

Study ID:




Start Date:

June 2008

Completion Date:

August 2011

Related Keywords:

  • Mammography
  • Estrogen
  • Lipemia
  • Endometrium
  • Ultrasonography
  • breast carcinoma; goserelin; Mammographic density
  • Breast Neoplasms