NL-OMON42456
Recruiting
Not Applicable
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 sites60 target enrollmentStarted: TBDLast updated:
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- IBCSG Coordinating Center
- Enrollment
- 60
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational invasive
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •\-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.
Exclusion Criteria
- •\- 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.
Investigators
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