Non-steroidal aromatase inhibitors breast cancer

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its identifier (NCT number): NCT02278120
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Sponsors and Collaborators Novartis Pharmaceuticals Investigators Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals   More Information
Responsible Party: Novartis Pharmaceuticals Identifier: NCT02278120     History of Changes Other Study ID Numbers: CLEE011E2301
First Submitted: October 22, 2014 First Posted: October 29, 2014 Last Update Posted: July 11, 2017 Last Verified: July 2017 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: Undecided Plan Description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

KEEP OUT OF REACH OF CHILDREN. WARNING: NOT FOR USE BY INDIVIDUALS UNDER THE AGE OF 21 YEARS. Consult a physician or licensed qualified health care professional before using this product if you have, or have a family history of,prostate cancer prostate enlargement, heart disease, low “good” cholesterol (HDL), or if you are using any other dietary supplement,prescription drug, or over-the-counter drug. Do not exceed recommended serving. Exceeding recommended serving may cause serious adverse health effects. Possible side effects include acne, hair loss, hair growth on the face (in women), aggressiveness, irritability, and increased levels of estrogen. Discontinue use and call a physician or licensed qualified health care professional immediately if you experience rapid heart beat, dizziness, blurred vision, or other similar symptoms. Made in a facility that may process dairy, peanuts, tree nuts, wheat, fish, barley and shellfish. Do not use if governed by any body that prohibits hormone use.

Aromatase inhibitor drugs (patent pharmaceuticals) are “approved” for estrogen receptor positive (ER+) early breast cancer and following Tamoxifen therapy. They include Aromasin ® (exemestane), an irreversible steroidal inhibitor; Femara ® (letrozole) and Arimidex ® (anastrozole), which are non-steroidal inhibitors. Aromatase inhibitors are generally not used to treat breast cancer in premenopausal women, since the decrease in estrogen stimulates androgen production by the ovaries, which will counteract their effect. The most common side effects of aromatase inhibitors are joint stiffness or joint pain. Regular bone density testing is recommended for those taking aromatase inhibitor drugs. 23-25

Oral administration of Anastrozole to female rats (from 2 weeks before mating to pregnancy day 7) produced significant incidence of infertility and reduced numbers of viable pregnancies at 1 mg/kg/day (about 10 times the recommended human dose on a mg/m 2 basis and 9 times higher than the AUC 0-24 hr found in postmenopausal volunteers at the recommended dose). Pre-implantation loss of ova or fetus was increased at doses equal to or greater than mg/kg/day (about one-fifth the recommended human dose on a mg/m 2 basis). Recovery of fertility was observed following a 5-week non-dosing period which followed 3 weeks of dosing. It is not known whether these effects observed in female rats are indicative of impaired fertility in humans.

Non-steroidal aromatase inhibitors breast cancer

non-steroidal aromatase inhibitors breast cancer

Oral administration of Anastrozole to female rats (from 2 weeks before mating to pregnancy day 7) produced significant incidence of infertility and reduced numbers of viable pregnancies at 1 mg/kg/day (about 10 times the recommended human dose on a mg/m 2 basis and 9 times higher than the AUC 0-24 hr found in postmenopausal volunteers at the recommended dose). Pre-implantation loss of ova or fetus was increased at doses equal to or greater than mg/kg/day (about one-fifth the recommended human dose on a mg/m 2 basis). Recovery of fertility was observed following a 5-week non-dosing period which followed 3 weeks of dosing. It is not known whether these effects observed in female rats are indicative of impaired fertility in humans.

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