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Brief Title: TRIal evalUating the Menstrual and Ovarian Function of Young Breast Cancer Patients Treated With a cycloPHosphamide-free Regimen
Official Title: A Phase II TRIal evalUating the Menstrual and Ovarian Function of Young Breast Cancer Patients Treated With a cycloPHosphamide-free Regimen Composed of Doxorubicin and Paclitaxel
Study ID: NCT02053597
Brief Summary: Recently, there has been a rising trend of delaying childbearing and hence more women are diagnosed with breast cancer before completing their families. Given the continuous decline in recurrences and death secondary to breast cancer and the reassuring data on the safety of pregnancy following breast cancer more women are inquiring into the possibility of preserving fertility following chemotherapy. The challenge remains in using a regimen that is devoid of cyclophosphamide, but is as effective as the standard regimens that incorporate cyclophosphamide. The combination doxorubicin (50 mg/m2) and paclitaxel (200 mg/m2) (AP) followed by 12 weeks of paclitaxel (80 mg/m2) (P) emerges as a treatment option with convincing results regarding its effectiveness in the early setting, and could be potentially associated with less ovarian toxicity being devoid of cyclophosphamide.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
GZA Ziekenhuisen Campus Sint-Augustinus - Iridium Kankernetwerk, Antwerp, Wilrijk, Belgium
Jules Bordet Institute, Brussels, , Belgium
Hôpital Erasme, Brussels, , Belgium
Clinique et Maternité Sainte Elisabeth, Namur, , Belgium
Name: Daphné Tkint de Roodenbeke, MD, PhD
Affiliation: Jules Bordet Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Hatem Azim, MD, PhD
Affiliation: Jules Bordet Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Isabelle Demeestere, MD, PhD
Affiliation: Hôpital Erasme
Role: PRINCIPAL_INVESTIGATOR