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

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 16-002730
    NCT ID: NCT02308085
    Sponsor Protocol Number: IBCSG 48-14/BIG 8-13,

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kathryn Ruddy, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

  • Brice B. Leclère, Florence F. Molinié, Brigitte B. Trétarre, Fabrizio F. Stracci, Laetitia L. Daubisse-Marliac, Marc M. Colonna, . . Cancer epidemiology 2013 Oct; (37):544-9 5

    Young women are not usually screened for breast cancer (BC). The trends in incidence in this population may better reflect changes in risk factors. However, studies on this subject are scarce and heterogeneous. The aim of this study was to describe the trends in incidence of BC in women under 40 from 1990 to 2008, using pooled European data. Thirty-seven European population-based cancer registries from Belgium, Bulgaria, France, Italy, Portugal, Spain and Switzerland participated in this study. World age-standardized incidence rates were first analyzed graphically and then using a Poisson regression model, in order to estimate average annual percent changes (AAPCs). The overall incidence rate of BC in the area covered increased linearly during the study period by 1.19% (0.93; 1.46) on average per year. This increase varied between countries from 0.20% (-0.53; 0.64) in Bulgaria to 2.68% (1.97; 3.40) in Portugal. In Italy, after a significant rise of 2.33% (1.14; 3.54) per year, BC incidence began decreasing in 2002 by -2.30% (-4.07; -0.50) yearly. The rise in incidence was greater for women under 35 and for ductal carcinomas. This increase can be due to a rise in risk factors and/or changes in diagnosis and surveillance practices, but we could not clearly distinguish between these two non-exclusive explanations.

  • Louise A LA. Brinton, Mark E ME. Sherman, J Daniel JD. Carreon, William F WF. Anderson. Journal of the National Cancer Institute 2008 Nov; (100):1643-8 22

    Increases in the incidence of postmenopausal breast cancers have been linked to screening and menopausal hormone use, but younger women have received less attention. Thus, we analyzed trends in breast cancer incidence (N = 387 231) using the National Cancer Institute's Surveillance, Epidemiology, and End Results Program 13-Registry database (1992-2004). Whites had higher incidence rates than blacks after age 40 years, but the reverse was true among younger women (black-white crossover). Among younger women, the rate per 100,000 woman-years was 16.8 for black vs 15.1 for white women; the highest black-white incidence rate ratio (IRR) was seen among women younger than 30 years (IRR = 1.52, 95% confidence interval = 1.34 to 1.73). This risk pattern was not observed in other ethnic groups. The black-white crossover among younger women was largely restricted to breast cancers with favorable tumor characteristics. The annual percentage change in the incidence of invasive breast cancers decreased modestly among older women but increased among younger (<40 years) white women. Continued surveillance of trends is needed, particularly for molecular subtypes that preferentially occur among young women.

  • Carey K CK. Anders, David S DS. Hsu, Gloria G. Broadwater, Chaitanya R CR. Acharya, John A JA. Foekens, Yi Y. Zhang, Yixin Y. Wang, P Kelly PK. Marcom, Jeffrey R JR. Marks, Phillip G PG. Febbo, Joseph R JR. Nevins, Anil A. Potti, Kimberly L KL. Blackwell. Journal of clinical oncology : official journal of the American Society of Clinical Oncology 2008 Jul; (26):3324-30 20

    Breast cancer arising in young women is correlated with inferior survival and higher incidence of negative clinicopathologic features. The biology driving this aggressive disease has yet to be defined.

  • Niels N. Bentzon, Maria M. Düring, Birgitte Bruun BB. Rasmussen, Henning H. Mouridsen, Niels N. Kroman. International journal of cancer 2008 Mar; (122):1089-94 5

    Estrogen receptor (ER) status is considered as an important prognostic factor as well as a predictive factor for endocrine responsiveness in breast cancer. We analyzed the distribution of ER status across age and estimated variations in the prognostic impact of ER status related to patients' age and time since diagnosis. Overall, 26,944 patients with primary breast cancer diagnosed from 1989 to 2004 were included. The proportion of ER positive tumors increased over age from 51 to 82%. In multivariate analysis of overall survival, ER positive status was found to be a significantly positive prognostic factor over all age groups. This effect was limited to the first 5 years after diagnosis, RR: 2.08 (95% CI: 1.95-2.22, p < 0.0001). Overall survival during the following 5 years was slightly superior for women with ER negative tumors, RR of death: 0.89 (95% CI: 0.79-1.00, p = 0.049). Results were unchanged in patients who did not receive adjuvant systemic therapy (n = 6,272). Thus, positive ER status does not confer a negative impact on survival in young women as has been previously reported. The inferior prognosis for ER negative patients during the first 5 years after diagnosis changes into a slightly superior residual prognosis compared to ER positive patients independent of use of adjuvant systemic therapy. This may have an impact on future designing of guidelines for adjuvant endocrine therapy beyond 5 years.

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20310178

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