Reproductive Health in Breast Cancer Survivor
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 22,000
- 试验地点
- 4
- 主要终点
- to describe pregnancies (number, origin and outcome) after stage 1 to 3 breast cancer in women aged 18 to 40 at diagnosis, according to age at diagnosis and treatment received.
研究概览
简要总结
With the age of first pregnancy increasing (average age of mother at childbirth: 31.0 in 2022), and the incidence of breast cancer increasing in young women (+2.1% per year according to some registries, more and more women will develop breast cancer before they have a child. FP must be offered to all women under 40 who are going to receive potentially gonadotoxic treatment (French bioethics law of 06/08/04, revised on 07/07/2011). It therefore seems appropriate to collect data from patients aged between 18 and 40 at diagnosis (previous fertility, fertility preservation before chemotherapy). Furthermore, the theoretical risk of pregnancy persists until the menopause. For the study of contraception, patients aged up to 50 at diagnosis will therefore be included. In view of the EMA's recent warning on the genotoxic risk of tamoxifen, the investigator feel that it would be relevant to collect data on the health status of newborns born after breast cancer (three compulsory medical examinations in the first month of life to detect any malformative pathologies).
A better understanding of these issues would enable national and even international recommendations to be updated, patients to be better informed and the long-term consequences on fertility to be better managed.
详细描述
The impact of cancer treatments on reproductive life and the health of unborn children is a major concern for young patients diagnosed and treated for cancer.
The information gathered by this project will make it possible to provide clearer and more accurate information to patients about the consequences of cancer therapies on their reproductive lives. In addition, the investigator hope to be able to reassure doctors about the use of fertility preservation before breast cancer and MPA after breast cancer, and to have arguments for fertility preservation and MPA to be offered more systematically to patients.
Answering such questions in prospective trials would require a long follow-up period and the inclusion of a very large number of patients. The creation of a multicentre retrospective database could provide answers to a large number of questions about the impact of anti-cancer therapies on reproductive life in the management of female breast cancer. In addition, to limit the risk of bias, these data will be compared with those of a population of women of the same age without breast cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Exposed cohort (Breast cancer patient)
- •Inclusion Criteria:
- •Patients aged between 18 and 50 at the time of diagnosis of breast cancer
- •Diagnosed with stage 1 to 3 breast cancer between 01/01/2010 and 31/12/2018
- •Patients treated in one of the identified ConSoRe partner centres (CLB, ICO, COL, IC)
排除标准
- •Diagnosis of metastatic breast cancer (stage 4)
- •Patients opposed to the use of their data for research purposes
- •Unexposed cohort (data from the SNDS) :
- •Population derived from the SNDS, among women not diagnosed with breast cancer, of the same ages (same year of birth) and the same geographical area (same département of residence) as the exposed population.
研究组 & 干预措施
Exposed cohort
Patients in ConSoRe data with a diagnosis of stage 1 to 3 breast cancer between 01/01/2010 and 31/12/2018.
Non-exposed cohort
Women present in the SNDS data, without a diagnosis of breast cancer, born between 01/01/1970 and 31/12/2000.
Cohort associated with the exposed cohort
Children of included patients born after diagnosis of breast cancer.
结局指标
主要结局
to describe pregnancies (number, origin and outcome) after stage 1 to 3 breast cancer in women aged 18 to 40 at diagnosis, according to age at diagnosis and treatment received.
时间窗: 4 years
Number of spontaneous and MPA pregnancies, with viable child or not, after stage 1 to 3 breast cancer in women aged 18 to 40 at diagnosis, according to age at diagnosis and treatments received.
次要结局
- a) Compare the pregnancy rate after breast cancer, for patients aged 18 to 40 at the time of diagnosis of breast cancer, with the pregnancy rate in a sample of women without breast cancer from the general population, overall and, for patients, by sub-gro(4 years)
- b) To describe the use of fertility preservation before chemotherapy: oncofertility consultation, preservation techniques for patients aged between 18 and 40 at the time of diagnosis of breast cancer.(4 years)
- c) Describe the link between recourse to MAP after cancer and the risk of recurrence, for patients aged between 18 and 40 at the time of diagnosis of breast cancer.(4 years)
- d) To describe the risk of breast cancer recurrence according to the time between stopping and restarting tamoxifen, for patients aged 18 to 40 at the time of diagnosis of breast cancer.(4 years)
- g) To describe the care pathway for patients aged between 18 and 50 at the time of diagnosis of breast cancer(4 years)
- e) To describe fetal malformations and perinatal pathologies in children born according to the duration of tamoxifen discontinuation (3 to 9 months vs. > 9 months), for patients aged 18 to 40 years at the time of breast cancer diagnosis.(4 years)
- f) To describe fetal malformations and perinatal pathologies in children born after tamoxifen was stopped 3 to 9 months before the start of pregnancy and after no tamoxifen was taken, in patients aged 18 to 40 at the time of diagnosis of breast cancer.(4 years)
- h) To describe contraception and the rate of abortion during and after treatment for breast cancer in patients aged between 18 and 50 at the time of their diagnosis.(4 years)