Genotype and phenotype guided supplementation of TAMoxifen standard therapy with ENDOXifen in breast cancer patients

Phase 2

• Conditions: C50; Malignant neoplasm of breast

• Registration Number: DRKS00017765
• Lead Sponsor: Robert Bosch Gesellschaft für medizinische Forschung mbH (RBMF)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-30
• Study Completion: 2021-05-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 356

Inclusion Criteria

Main Inclusion Criteria: Pre- and postmenopausal female patients with DCIS or stage I, IIA, IIB or IIIA invasive breast cancer who have received at least three months standard tamoxifen treatment before baseline visit.

Exclusion Criteria

Main Exclusion Criteria: Locally advanced (Stadium IIIB or IIIC) or metastatic (Stage IV) breast cancer, ongoing chemotherapy and/or treatment with trastuzumab within the last three months, other active second malignancy, pregnancy, breast feeding/lactation, severe chronic or acute respiratory, cardiac, renal or endocrine diseases.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is reached if in one or both intervention groups, the proportion of patients with steady state (Z)-endoxifen plasma concentration > 32 nM is greater or equal to the proportion of patients in the control group that reaches steady state (Z)-endoxifen plasma concentration of > 32 nM at the end of the 6 weeks intervention period.

Secondary Outcome Measures

Name	Time	Method
• Increase in steady state (Z)-endoxifen concentration from baseline to end of intervention (Visit 3) in patients with or without supplementation of (Z)-endoxifen <br>• Steady state plasma concentrations of tamoxifen, desmethyltamoxifen, 4-hydroxytamoxifen, and other tamoxifen metabolites following (Z)-endoxifen supplementation for 6 weeks