Breast Cancer Clinical Trial
Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer
Summary
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.
Full 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.
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.
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There are 138 Locations for this study
Los Angeles California, 90211, United States
Palo Alto California, 94305, United States
San Diego California, , United States
Aurora Colorado, 80045, United States
Boulder Colorado, 80303, United States
Denver Colorado, 80218, United States
Fort Collins Colorado, 80524, United States
Derby Connecticut, 06418, United States
Fairfield Connecticut, 06824, United States
Hartford Connecticut, 06105, United States
New Haven Connecticut, 06520, United States
North Haven Connecticut, 06473, United States
Orange Connecticut, 06477, United States
Torrington Connecticut, 06790, United States
Trumbull Connecticut, 06611, United States
Waterbury Connecticut, 06708, United States
Newark Delaware, 19713, United States
Newark Delaware, 19718, United States
Newport Delaware, 19713, United States
Newport Delaware, 19713, United States
Washington District of Columbia, 20007, United States
Washington District of Columbia, 20016, United States
Atlanta Georgia, 30308, United States
Atlanta Georgia, 30322, United States
Honolulu Hawaii, 96701, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96817, United States
Chicago Illinois, 60612, United States
Danville Illinois, 61832, United States
Effingham Illinois, 62401, United States
Evanston Illinois, 60201, United States
Evanston Illinois, 60201, United States
Glenview Illinois, 60026, United States
Highland Park Illinois, 60035, United States
Mattoon Illinois, 61938, United States
Skokie Illinois, 60076, United States
Urbana Illinois, 61801, United States
Urbana Illinois, 61801, United States
Indianapolis Indiana, 46202, United States
Baltimore Maryland, 21204, United States
Baltimore Maryland, 21218, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48103, United States
Brighton Michigan, 48114, United States
Brighton Michigan, 48114, United States
Canton Michigan, 48188, United States
Canton Michigan, 48188, United States
Chelsea Michigan, 48118, United States
Chelsea Michigan, 48118, United States
Ypsilanti Michigan, 48198, United States
Bemidji Minnesota, 56501, United States
Coon Rapids Minnesota, 55433, United States
Duluth Minnesota, 55805, United States
Edina Minnesota, 55435, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55415, United States
Rochester Minnesota, 55902, United States
Saint Louis Park Minnesota, 55343, United States
Saint Paul Minnesota, 55101, United States
Saint Louis Missouri, 63131, United States
Bozeman Montana, 59715, United States
Lebanon New Hampshire, 03756, United States
Albuquerque New Mexico, 87131, United States
Bronx New York, 10461, United States
Bronx New York, 10461, United States
Bronx New York, 10467, United States
New York New York, 10065, United States
Syracuse New York, 13210, United States
White Plains New York, 10601, United States
Chapel Hill North Carolina, 27599, United States
Clinton North Carolina, 28328, United States
Goldsboro North Carolina, 27534, United States
Hendersonville North Carolina, , United States
Jacksonville North Carolina, 28546, United States
Wilson North Carolina, 27534, United States
Bismarck North Dakota, 58501, United States
Fargo North Dakota, 58102, United States
Fargo North Dakota, 58122, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43210, United States
Orange Village Ohio, 44122, United States
Pittsburgh Pennsylvania, 15213, United States
Providence Rhode Island, 02905, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29611, United States
Greer South Carolina, 29650, United States
Seneca South Carolina, 29672, United States
Spartanburg South Carolina, 29303, United States
Spartanburg South Carolina, 29307, United States
Sioux Falls South Dakota, 57104, United States
Sioux Falls South Dakota, 57104, United States
Laredo Texas, 78045, United States
Salt Lake City Utah, 84112, United States
Burlington Vermont, 05401, United States
Mechanicsville Virginia, 23116, United States
Midlothian Virginia, 23114, United States
Richmond Virginia, 23223, United States
Seattle Washington, 98109, United States
Seattle Washington, 98109, United States
Seattle Washington, 98195, United States
Perth Western Australia, 6008, Australia
Graz , 8036, Austria
Innsbruck , 6020, Austria
Salzburg , 5020, Austria
Vienna , 1090, Austria
Brussels , 1200, Belgium
Brussels , , Belgium
Brussels , , Belgium
Leuven , 3000, Belgium
Liege , 4000, Belgium
Namur , 5000, Belgium
Calgary Alberta, T2N 4, Canada
Vancouver British Columbia, V5Z 1, Canada
Toronto Ontario, M5B 1, Canada
Toronto Ontario, M5G 1, Canada
Toronto Ontario, , Canada
Montréal Quebec, H2X 3, Canada
Quebec City Quebec, G1S 4, Canada
Sherbrooke Quebec, , Canada
København , 2100, Denmark
Bordeaux , 33076, France
Lille , 59020, France
Lyon , 69373, France
Paris , , France
Stavrakia Crete, 71110, Greece
Athens , , Greece
Debrecen , , Hungary
Dublin 8 , , Ireland
Dublin , , Ireland
Galway , , Ireland
Limerick , , Ireland
Waterford , , Ireland
Jerusalem , , Israel
Tel Hashomer , 52656, Israel
Prato Firenze, , Italy
Carpi Modena, 41012, Italy
Castellanza Vareze, , Italy
Aviano , 33081, Italy
Biella , , Italy
Bolzano , 39100, Italy
Genova , , Italy
Meldola , , Italy
Milan , 20141, Italy
Novara , 28100, Italy
Pavia , 27100, Italy
Rimini , 47923, Italy
Rome , , Italy
Trento , 38122, Italy
Varese , 21100, Italy
Viterbo , , Italy
Amagasaki Hyogo, 660-8, Japan
Hamamatsu Shizuoka, , Japan
Fukuoka , 811-1, Japan
Kagoshima , , Japan
Kawasaki , , Japan
Kyoto , , Japan
Matsuyama , , Japan
Minato-ku, Tokyo , 105-8, Japan
Nagoya , 463-0, Japan
Okayama , , Japan
Sendai , , Japan
Tokyo , , Japan
Tokyo , , Japan
Tokyo , , Japan
Tokyo , , Japan
Tokyo , , Japan
Tsukuba , , Japan
Ōsaka , , Japan
Seoul , 06351, Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Beirut , , Lebanon
Leiden , 2300 , Netherlands
Oslo , , Norway
Lisbon , , Portugal
Belgrade , , Serbia
Ljubljana , , Slovenia
El Palmar Murcia, , Spain
Barcelona , 08035, Spain
Barcelona , , Spain
Donostia , , Spain
Gerona , , Spain
Madrid , 28050, Spain
Madrid , , Spain
Madrid , , Spain
Málaga , 29010, Spain
Oviedo , , Spain
Palma , , Spain
Pamplona , , Spain
Santiago de Compostela , , Spain
Sevilla , 41013, Spain
Sevilla , , Spain
Toledo , , Spain
Valencia , , Spain
Zaragoza , , Spain
Thun Bern, 3600, Switzerland
Baden , 5404, Switzerland
Basel , 4031, Switzerland
Bellinzona , , Switzerland
Bern , 3010, Switzerland
Bern , 3012, Switzerland
Frauenfeld , , Switzerland
Genève , 1211, Switzerland
Lausanne , , Switzerland
Sion , 736, Switzerland
St. Gallen , 9007, Switzerland
Zurich , 8091, Switzerland
Zürich , 8008, Switzerland
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