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Endocrine Therapy Interruption for Breast Cancer During Pregnancy (POSITIVE Trial)
POSITIVE Trial Summary
This trial is investigating whether or not temporarily interrupting endocrine therapy, in order to allow pregnancy, increases the risk of breast cancer recurrence. The study will also evaluate different indicators related to fertility, pregnancy, and breast cancer biology.
POSITIVE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPOSITIVE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.POSITIVE Trial Design
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Who is running the clinical trial?
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- I do not have any health conditions that would make it unsafe for me to join the study.I have been part of a clinical trial for hormone therapy or received preventive drug treatment.I want to become pregnant.I have or had another type of cancer besides breast cancer.I have had a hysterectomy, both ovaries removed, or radiation to the ovaries.I may have had chemotherapy or other treatments for my cancer before or after surgery, based on my doctor's advice and my choice.I was diagnosed with cancer in both breasts within the last 2 months.I was post-menopausal at the time of my breast cancer diagnosis.I am between 18 and 42 years old.I have had breast cancer before, either in the same or the other breast.I stopped my hormone therapy for cancer less than a month ago.I was premenopausal when diagnosed with breast cancer.My records show no signs of cancer spread in my body.I have a BRCA1 or BRCA2 gene mutation.I have taken hormone therapy for breast cancer for 18 to 30 months.I was diagnosed with breast cancer during my pregnancy.My breast cancer has returned or spread to other parts.
- Group 1: Endocrine therapy interruption
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are participants being actively recruited for this medical experiment?
"As reported on clinicaltrials.gov, this medical study has concluded its recruitment phase and is no longer taking applications. Initially posted in December 2014 with a final update made in August 2022, this trial has been superseded by the other 2290 trials currently recruiting participants."
Is it feasible for me to register in this clinical trial?
"This clinical trial, which is enrolling 518 individuals afflicted with breast cancer between 18 and 42 years of age, mandates that participants have only recently stopped adjuvant endocrine therapy (SERM alone, GnRH analogue plus SERM or AI) for a period of 18-30 months. Moreover, those wishing to become pregnant are eligible as well as patients who underwent oocyte/embryo/ovarian tissue cryopreservation at the time of diagnosis or received pharmaco-prevention. Lastly, neo/adjuvant chemotherapy and other systemic therapies may have been administered according to institutional policy and patient preference."
In what locations can this research be accessed?
"Potential participants of this study can find a trial site at Sanford Clinic North - Bemidji in Minnesota, Bozeman Deaconess Hospital in Montana, and the Roger Maris Cancer Centre in Fargo. Additionally, there are over 100 other medical locations involved as well."
Is this investigative research open to individuals 80 years of age or older?
"This medical trial is limited to patients aged 18-42. While there are 64 other trials for minors, 2208 studies exist that enroll individuals over the age of 65."
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