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



Status:Recruiting
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 42
Updated:12/12/2018
Start Date:December 2014
End Date:December 2028

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

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.

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.

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.
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4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
(763) 236-6000
Principal Investigator: Daniel M Anderson, MD
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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3400 N Charles St
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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825 Eastlake Ave E
Seattle, Washington 98109
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1100 Fairview Avenue North
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5301 McAuley Drive
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550 Peachtree St NE
Atlanta, Georgia 30308
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450 Brookline Ave
Boston, Massachusetts 2215
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915 Highland Blvd
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7575 Grand River Avenue
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1825 Eastchester Road
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Bronx, New York 10461
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1969 W Ogden Ave
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John H. Stroger, Jr. Hospital of Cook County The Level 1 Trauma Center is one...
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6401 France Ave S
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Fairfield, Connecticut 06824
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820 4th Street North
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737 North Broadway Drive
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1024 S Lemay Ave
Fort Collins, Colorado 80524
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2100 Pfingsten Road
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Hartford, Connecticut 06105
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777 Park Avenue West
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888 S King St
Honolulu, Hawaii 96813
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Straub Clinic And Hospital Founded in 1921, Straub Clinic & Hospital is a fully integrated...
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321 N Kuakini St
Honolulu, Hawaii 96817
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Oncare Hawaii Inc-Kuakini OnCare Hawaii is a Certified PROVENGE® Treatment Center. PROVENGE (sipuleucel-T) is the...
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239 Station Street
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Laredo, Texas 78041
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Lebanon, New Hampshire 03756
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8260 Atlee Road
Mechanicsville, Virginia 23116
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13710 Saint Francis Boulevard
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800 East 28th Street
Minneapolis, Minnesota 55407
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900 South 8th Street
Minneapolis, Minnesota 55415
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333 Cedar Street
New Haven, Connecticut 06510
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445 E 69th St
New York, New York 10021
(212) 746-1067
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Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
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4701 Ogletown-Stanton Road
Newark, Delaware 19713
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4755 Ogletown-Stanton Road
Newark, Delaware 19718
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4701 Ogletown-Stanton Road
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12 Salvado Road
Perth, Western Australia 6008
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3015 North Ballas Road
Saint Louis, Missouri 63131
(314) 996-5000
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640 Jackson Street
Saint Paul, Minnesota 55101
651-254-3456
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
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1959 NE Pacific St
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Seneca, South Carolina 29672
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1309 West 17th Street
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Spartanburg, South Carolina 29307
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750 East Adams Street
Syracuse, New York 13210
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200 Kennedy Drive
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Urbana, Illinois 61801
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5255 Loughboro Rd NW
Washington, District of Columbia 20016
(202) 537-4000
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 444-2000
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Waterbury, Connecticut 06708
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203 Cox Boulevard
Wilson, North Carolina 27534
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5301 East Huron River Drive
Ypsilanti, Michigan 48197
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