A study evaluating the pregnancy outcomes and safety of interrupting endocrine therapy for young women with endocrine responsive breast cancer who desire pregnancy - POSITIVE study

IBCSG Coordinating Center0 个研究点目标入组 60 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•-Age * 18 and * 42 years at enrollment.
•-Has received adjuvant endocrine therapy (SERM alone, GnRH analogue plus SERM or AI) for *18 months but *30 months for early breast cancer.
•-The adjuvant endocrine therapy must have stopped within 1 month prior to enrollment.
•- Patient wishes to become pregnant.
•- Breast cancer for which patient is receiving endocrine therapy must have
•been histologically-proven stage I-III, endocrine-responsive (i.e., estrogen
•and/or progesterone receptor positive, according to local definition of
•positive, determined using immunohistochemistry (IHC)), and treated
•with curative intent.
•-Patient must be premenopausal at breast cancer diagnosis, as determined locally and documented in patient record.
•-Patient must be without clinical evidence of loco-regional and distant disease, as evaluated according to institutional assessment standards and documented in the patient record.
•- Written informed consent (IC) for trial participation *
•- Written consent to biological material submission
•- The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines.
•-Patient must be accessible for follow-up.

•- Post-menopausal patients at BC diagnosis, as determined locally.
•- History of hysterectomy, bilateral oophorectomy or ovarian irradiation.
•- Patients with current local, loco-regional relapse and/or distant metastatic breast cancer.
•- Patients with a history of prior (ipsi- and/or contralateral) invasive BC.
•- Patients with previous or concomitant non-breast invasive malignancy.
•Exceptions are limited exclusively to patients with the following previous
•malignancies, if adequately treated: basal or squamous cell carcinoma of
•the skin, in situ non-breast carcinoma, contra- or ipsilateral in situ breast
•carcinoma, stage Ia carcinoma of the cervix.
•- Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical disorder that would interfere with the patient*s safety.
•- Patients with a history of noncompliance to medical treatments and/or considered potentially unreliable.
•- Patients with psychiatric, addictive, or any disorder that would prevent compliance with protocol requirements.

发起方

IBCSG Coordinating Center