Clinical Trials /

Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer

NCT02308085

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

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

  • Early Breast Cancer

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

NameTypeDescriptionInterventions
Endocrine therapy interruptionExperimentalEndocrine 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:Recruiting
    Lead Sponsor:International Breast Cancer Study Group

    Trial Keywords

    • Premenopausal
    • endocrine responsive
    • Breast
    • Pregnancy

    Last Updated