A study evaluating the pregnancy outcomes and safety of interrupting endocrine therapy for young women with endocrine responsive breast cancer who desire pregnancy
- Conditions
- breast cancer1000629110013356
- Registration Number
- NL-OMON42456
- Lead Sponsor
- IBCSG Coordinating Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
-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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint:<br /><br>Breast cancer free interval (BCFI) defined as the time from enrollment in the<br /><br>study to the first invasive BC event (local, regional, or distant<br /><br>recurrence or a new invasive contralateral BC).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints:<br /><br>Menstruation recovery and pattern.<br /><br>Pregnancy (determined by pregnancy test).<br /><br>Pregnancy outcome: full term pregnancy, caesarean section, abortion,<br /><br>miscarriage, ectopic, stillbirth.<br /><br>Offspring outcome: preterm birth, low birth weight, birth defects.<br /><br>Breastfeeding; pattern of breastfeeding (duration, use ipsilateral breast if<br /><br>previous breast conservation, side exclusivity).<br /><br>Use of assisted reproductive technology (ART).<br /><br>Adherence to endocrine treatment assessed by:<br /><br>- Treatment resumption after the ~2 year ET break.<br /><br>- Total duration of at least 5 years of ET.<br /><br>Distant recurrence-free interval (DRFI), defined as the time from enrollment in<br /><br>the study to the first BC recurrence in a distant site,<br /><br>excluding second (non-breast) primary cancers and contralateral breast cancer.</p><br>