Description:
The best available evidence suggests that pregnancy after breast cancer does not increase a
woman's risk of developing a recurrence from her breast cancer. In particular, the most
recent data suggest that this is the case also in women with a hormone receptor-positive
breast cancer. There is also no indication of increased risk for delivery complications or
for the newborn. The aim of the study is to investigate if temporary interruption of
endocrine therapy, with the goal to permit pregnancy, is associated with a higher risk of
breast cancer recurrence.The study aims also to evaluate different specific indicators
related to fertility, pregnancy and breast cancer biology in young women. A
psycho-oncological companion study on fertility concerns, psychological well-being and
decisional conflicts will be conducted in interested Centers.
Title
- Brief Title: Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer
- Official Title: A Study Evaluating the Pregnancy Outcomes and Safety of Interrupting Endocrine Therapy for Young Women With Endocrine Responsive Breast Cancer Who Desire Pregnancy
Clinical Trial IDs
- ORG STUDY ID:
IBCSG 48-14 / BIG 8-13
- SECONDARY ID:
Alliance A221405
- SECONDARY ID:
NCIC CTG MAC.18
- NCT ID:
NCT02308085
Conditions
Purpose
The best available evidence suggests that pregnancy after breast cancer does not increase a
woman's risk of developing a recurrence from her breast cancer. In particular, the most
recent data suggest that this is the case also in women with a hormone receptor-positive
breast cancer. There is also no indication of increased risk for delivery complications or
for the newborn. The aim of the study is to investigate if temporary interruption of
endocrine therapy, with the goal to permit pregnancy, is associated with a higher risk of
breast cancer recurrence.The study aims also to evaluate different specific indicators
related to fertility, pregnancy and breast cancer biology in young women. A
psycho-oncological companion study on fertility concerns, psychological well-being and
decisional conflicts will be conducted in interested Centers.
Detailed Description
Recent decades have witnessed a delay in childbearing for a variety of reasons including
cultural, educational, and professional. As a consequence, 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.The best available
evidence suggests that pregnancy after breast cancer does not increase a woman's risk of
developing a recurrence.For women desiring pregnancy after a breast cancer, 5-10 years of
endocrine therapy may substantially reduce the chance of conception; however, a shorter
duration of endocrine therapy in this population has not been studied in a prospective
manner.
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. No prospective definitive data are available.
Trial Arms
Name | Type | Description | Interventions |
---|
Endocrine therapy interruption | Experimental | Endocrine therapy interruption after having completed between ≥ 18 months and ≤ 30 months. | |
Eligibility Criteria
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.
Note: Patients who have received neo/adjuvant endocrine treatment within a clinical trial
and patients who have received pharmaco-prevention are eligible.
- The adjuvant endocrine therapy must have stopped within 1 month prior to enrollment.
- Patient wishes to become pregnant. Note: Patients who have undergone
oocyte/embryo/ovarian tissue cryopreservation at breast cancer diagnosis and/or have a
previous history of assisted reproductive technology (ART) are eligible.
- 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.
Note:
- Patients with synchronous bilateral invasive breast cancer (diagnosed histologically
within 2 months) are eligible.
- Patient with invasive breast cancer or synchronous bilateral invasive breast cancer
(diagnosed histologically within 2 months) during pregnancy are eligible.
- Patients with BRCA1/2 mutations are eligible.
- Patients could have received neo/adjuvant chemotherapy, or other systemic therapy
(e.g., neo/adjuvant HER2-targeted therapy) according to institutional policy and
patient's desire.
- 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:
- 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.
Maximum Eligible Age: | 42 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Breast Cancer free interval (BCFI) |
Time Frame: | From enrollment until the first invasive BC event, assessed up to 14 years |
Safety Issue: | |
Description: | Kaplan-Meier Analysis |
Secondary Outcome Measures
Measure: | Information on Menstruation recovery and pattern |
Time Frame: | Up to 24 months after enrollment |
Safety Issue: | |
Description: | Menstrual diary |
Measure: | Pregnancy rate (determined by pregnancy test) |
Time Frame: | Up to 24 months after enrollment |
Safety Issue: | |
Description: | Pregnancy test |
Measure: | Pregnancy outcome |
Time Frame: | Up to 33 months after enrollment |
Safety Issue: | |
Description: | Labor and delivery Information, full term pregnancy, caesarean section, abortion, miscarriage, ectopic, stillbirth rates. |
Measure: | Offspring outcome |
Time Frame: | Up to 33 months after enrollment |
Safety Issue: | |
Description: | Collect information on preterm birth, low birth weight, births defects rates. |
Measure: | Breastfeeding pattern |
Time Frame: | Up to 36 months after enrollment |
Safety Issue: | |
Description: | Analysis of pattern e.g Duration, use of ipsilateral breast if previous breast conservation, side exclusivity |
Measure: | Use of assisted reproductive Technology (ART) |
Time Frame: | Up to 24 months after enrollment |
Safety Issue: | |
Description: | ART use will be tabulated |
Measure: | Distant recurrence-free interval (DRFI) |
Time Frame: | Time from enrollment in the study to the first breast cancer recurrence in a distant site, assessed up to 14 years |
Safety Issue: | |
Description: | Kaplan-Meier Analysis |
Details
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | International Breast Cancer Study Group |
Trial Keywords
- Premenopausal
- endocrine responsive
- Breast
- Pregnancy
Last Updated
February 15, 2021