drugset / Trial / NCT02053597

TRIal evalUating the Menstrual and Ovarian Function of Young Breast Cancer Patients Treated With a cycloPHosphamide-free Regimen

NCT02053597 ↗

Phase 2 Withdrawn Jules Bordet Institute
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2014-10
Primary completion
2015-07
Completion
2015-07

Outcome

Outcome not reported

Stopped: “due to evolving scientific knowledge in the field that would make the questions being addressed in the trial less relevant”

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxorubicin Other / unclassified 50 mg/m2 —
Subject Paclitaxel Small molecule 80 mg/m2 —

Indications