Premenopausal endocrine responsive early breast cancer
Conditions
Interventions
Endocrine therapy interruption after having completed between >
= 18 months and <
= 30 months 3 months wash-out between treatment interruption and pregnancy attempt Up to 2 years interruption to allow pregnancy, delivery, breastfeeding or failure to conceive Endocrine therapy re
s preference
Sponsors
International Breast Cancer Study Group (IBCSG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: -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 must be signed and dated by the patient and the investigator prior to enrollment. -Written consent to biological material submission, indicating the patient has been informed of and agrees to tissue and blood material use, transfer and handling, must be signed and dated by the patient and the investigator prior to any procedures specific for this trial. -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.
Exclusion criteria
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. -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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Breast Cancer free interval (BCFI) defined as the time from enrollment in the study to the first invasive BC event (local, regional, or distant recurrence or a new invasive contralateral BC). | — |
Secondary
| Measure | Time frame |
|---|---|
| -Menstruation recovery and pattern. -Pregnancy (determined by pregnancy test). -Pregnancy outcome: full term pregnancy, caesarean section, abortion, miscarriage, ectopic, stillbirth. -Offspring outcome: preterm birth, low birth weight, birth defects. -Breastfeeding; pattern of breastfeeding (duration, use ipsilateral breast if previous breast conservation, side exclusivity). -Use of assisted reproductive technology (ART). -Adherence to endocrine treatment assessed by: -- Treatment resumption after the ~2 year ET break. -- Total duration of at least 5 years of ET. -Distant recurrence-free interval (DRFI), defined as the time from enrollment in the study to the first BC recurrence in a distant site, excluding second (non-breast) primary cancers and contralateral breast cancer. | — |
Countries
Japan,Asia(except Japan),North America,Australia,Europe
Contacts
Public ContactJun Fukase
JBCRG (Japan Breast Cancer Research Group) Head office
Outcome results
None listed