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临床试验/NCT02311647
NCT02311647Unknown不适用

Uterine Cavity Assessment and Endometrial Gene Expression in Tamoxifen Treated Breast Cancer Patients

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Endometrial cells gene expression post Tamoxifen exposure

研究概览

简要总结

The aim of this multi-center study is to assess the effects of Tamoxifen on the uterine cavity and endometrial abnormalities in young premenopausal women diagnosed with breast cancer.

The research contains two parts: a clinical study and a laboratory study.

  • Clinical part: to evaluate the association between tamoxifen treatment and uterine abnormalities.
  • Laboratory part: to investigate the effect of Tamoxifen treatment on endometrial tissue, by exploring the molecular aspect of endometrial receptivity.

详细描述

Breast cancer is the most prevalent malignancy amongst women and approximately 13% of newly diagnosed breast cancer patients are diagnosed between the ages 20-34 [1]. At this age group women are at the peak of their reproductive years, and many have not yet completed family planning. Moreover the age at first birth has steadily increasing in developed nations [2] and more than a quarter of the deliveries are in women above the age of 35. Despite repeated reports in the literature of a worse prognosis in young breast cancer patients, newer treatments have none-the-less improved the outcome amongst young women and for some early stage disease subtypes the outcome is similar to that of older women [3,4]. These increasing numbers of breast cancer survivors are concerned with post-cancer quality of life issues, such as the ability to have children after completing treatment [5-6], hence it is critical to discuss fertility preservation and the ability to conceive when breast cancer is diagnosed [7-9].

Treatment for early breast cancer involves local therapy that includes surgery and adjuvant radiation therapy as well as systemic therapies including chemotherapy, biological therapy and hormonal therapy. Chemotherapy protocols for breast cancer include different combinations of alkylating agents, platinum derivates and taxanes that are toxic to the ovaries, destroy primordial follicle stockpiles, which directly represent ovarian reserve and can result in infertility and premature menopause [10-12].

Tamoxifen Citrate, a Selective Estrogen Receptor Modulator (SERM), competes with estrogen for binding sites in the Estrogen Receptor (ER) in target tissues such as breast. The drug has been in use for over 30 years with a proven high therapeutic index and significant efficacy. The drug is effective in reducing breast cancer recurrence and improving patient's survival across all age groups. The drug is effective in young pre-menopausal breast cancer patients [13-15] . Recently, it has been reported (16) that breast cancer survivors who take tamoxifen for ten years have half the risk of dying from estrogen receptor positive breast cancer. Therefore the new ASCO (American Society of Clinical Oncology ) recommendations are to increase the period of tamoxifen treatment.

However, at this period these patients cannot conceive, in order to enable pregnancy patients should hold Tamoxifen treatment, either with complete termination, or (a more suitable option with the new recommendations) a tamoxifen free window to allow pregnancy should be offered. If ovarian function is preserved women can try to get a spontaneous pregnancy. In patients that suffer from ovarian failure post chemotherapy treatments or embryos (or eggs) that were stored at diagnosis during fertility preservation procedure can be used.

Pregnancies post (and even during) tamoxifen treatment are reported but former breast cancer patients achieve lower pregnancy rate when performing embryo transfer with embryos that were frozen prior to treatment. The chances to conceive post tamoxifen treatments and even more with prolong Tamoxifen treatments are not determined. This becomes of major importance when a limited window of time is allowed for conception.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Breast cancer patients who are:
  • < 45 years
  • premenopausal
  • Had no previous uterine operations (previous D&C is allowed)
  • Currently receiving or having received Tamoxifen for at least 1 year.

排除标准

  • 未提供

结局指标

主要结局

Endometrial cells gene expression post Tamoxifen exposure

时间窗: 2 years

次要结局

  • Endometrial polyps post Tamoxifen exposure(2 years)
  • Endometrial thickness post Tamoxifen exposure(2 Years)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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