Primary objectiveTo assess the risk of breast cancer relapse associated with temporaryinterruption of endocrine therapy (ET) to permit pregnancy.Secondary objectiveTo evaluate factors associated with pregnancy success after interruption ofendocrine…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint:
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 outcome
Secondary endpoints:
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.
Background summary
Breast cancer in young women often occurs before the completion of reproductive
plans. Infertility has a significant impact on quality of life, resulting in
substantial distress in younger women with breast cancer and influencing
treatment decisions in a consistent proportion of patients. For women desiring
pregnancy after a breast cancer, 5-10 years of ET may substantially reduce the
chance of conception; however, a shorter duration of ET in this population has
not been studied in a prospective manner. The best available evidence suggests
that pregnancy after breast cancer does not increase a woman*s risk of
developing a recurrence. Birth outcome after breast cancer has not been shown
to be different from that of the normal population, but increased risks of
delivery complications, cesarean section, preterm birth and low birth weight
have been reported. Endocrine agents are potentially teratogenic: taking into
account their median half-life, waiting 3 months after their interruption
before attempting conception is considered safe. The limited evidence available
on breastfeeding after breast cancer reports successful lactation from the
treated breast in approximately 30% of women without detrimental effect on
survival. Currenty there are no prospective data.
Study objective
Primary objective
To assess the risk of breast cancer relapse associated with temporary
interruption of endocrine therapy (ET) to permit pregnancy.
Secondary objective
To evaluate factors associated with pregnancy success after interruption of
endocrine therapy.
Study design
A single-arm, phase II trial evaluating the pregnancy outcomes and safety of
interrupting endocrine therapy for young women with endocrine responsive breast
cancer who desire pregnancy
Study burden and risks
Burden: extra bloodsampling and outpatient clinic visits
Risks: prospectively unkown if interruption of hormonal therapy after 18-30
monthes is safe for breast cancer ercurrence
Effingerstrasse 40
Bern CH-3008
CH
Effingerstrasse 40
Bern CH-3008
CH
Listed location countries
Age
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.
-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.
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
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02308085 |
| CCMO | NL54300.058.15 |