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Breast Cancer, Young Women, Pregnancy Outcomes (POSITIVE) (A221405)

A Study Evaluating the Pregnancy Outcomes and Safety of Interrupting endocrine Therapy for Young Women With Endocrine Responsive Breast Cancer Who Desire Pregnancy (POSITIVE)

Objective

Overview

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.

Key Inclusion Criteria

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 inten

Key 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.

Study Type: Interventional

Learn More

ClinicalTrials.Gov

IRB Protocol Number
A221405
Principal Investigator(s)
Dr. Amarinthia Curtis, M.D.

Clinical Trial Categories

  • Symptom Management & Cancer Control
  • Oncology
  • Breast Cancer
Sponsor(s)
International Breast Cancer Study Group
Contact
Kristy Smith, RN at 864-560-1051
or ksmith4@srhs.com
How to Participate

Kristy Smith, RN

864-560-1051 or 864-560-6812

ksmith4@srhs.com

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