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Real-world evidence is woven into the fabric of how we innovate and advance care for patients with breast cancer, supporting our randomized clinicaltrials,” said Chris Boshoff, M.D., However, this observational analysis differs from the randomized clinicaltrial in several ways.
Across clinicaltrials (PALOMA-1, PALOMA-2, PALOMA-3), 1.0% IBRANCE may impair fertility in males and has the potential to cause genotoxicity. Advise women not to breastfeed during IBRANCE treatment and for 3 weeks after the last dose because of the potential for serious adverse reactions in nursing infants.
Exposure to sorbitol during lactation causes metabolic alterations and genotoxic effects in rat offspring. based weight loss intervention in adults with obesity: A randomized clinicaltrial. Proceedings of the National Academy of Sciences of the United States of America. 2012;109(16):5984-5988. DOI: 10.1073/pnas.1120794109.
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