Early Cardiac Toxicity of Adjuvant CT in Elderly BC.

Phase 2

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: epirubicin, cyclophosphamide, docetaxel

• Registration Number: NCT01301040
• Lead Sponsor: Jules Bordet Institute

Brief Summary

The primary objective is to evaluate the difference in cardiac strain rate evolution in elderly early BC patients treated with (neo) adjuvant anthracycline-based chemotherapy compared with a non-anthracycline regimen (Taxotere-cyclophosphamide) CT.

This study also will compare the serum biomarkers profile during and after the (neo) adjuvant CT in both treatment arms, assess whether MRI allows detecting earlier than standard echocardiography the signs of cardiotoxicity, during and after adjuvant (neo) CT, assess whether brain PET-CT allows detecting regional functional impairment in patients receiving CT, evaluate cognitive function before and after (neo) adjuvant CT in both treatment arms, evaluate distress and functional autonomy before and after (neo) adjuvant CT in both treatment arms, evaluate psychological state and burden of primary caregivers before and after (neo) adjuvant CT in both treatment arms, evaluate primary caregivers abilities to detect patients' distress and functional autonomy before and after (neo) adjuvant CT in both treatment arms, evaluate the short and long-term toxicity profile of the regimens, estimate the 10-year risk of relapse and/or death using the Adjuvant!Online tool, and estimate the Framingham risk score for Hard Coronary Heart Disease (10-year risk).

Detailed Description

Considering that both anthracycline-based and Taxotere-cyclophosphamide CT have established efficacy in the adjuvant treatment of elderly patients with early breast cancer, and the paucity of data for early cardiac toxicities with anthracycline-based adjuvant therapy compared to non-anthracycline regimen, this is the first randomized study to evaluate early cardiac signs based on doppler myocardial imaging (DMI). The results of this study could improve the monitoring of the cardiac function of elderly patients candidates to receive adjuvant chemotherapy for early breast cancer.

Study Timeline

• Status Verified: 2011-02
• Study First Submitted: 2011-02-18
• Study First Submitted QC: 2011-02-18
• Study First Posted: 2011-02-23
• Study Start: 2011-03
• Primary Completion: 2013-03
• Last Update Submitted: 2013-08-29
• Last Update Posted: 2013-08-30
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epirubicin/Cyclophosphamide	epirubicin, cyclophosphamide, docetaxel	Treatment arm 1: EC - epirubicin (100mg/m2 IV) and cyclophosphamide (600mg/m2 IV) every 3 weeks for 4 cycles
docetaxel/cyclophosphamide	epirubicin, cyclophosphamide, docetaxel	Treatment Arm 2: TC - docetaxel (Taxotere) (75mg/m2 IV) and cyclophosphamide (600mg/m2 IV) every 3 weeks for 4 cycles.

Primary Outcome Measures

Name	Time	Method
The difference between cardiac strain rates measured at baseline and after 4 cycles of chemotherapy.	Before chemotherapy, after chemotherapy, at 6 months, one , two and 3 years from randomization.	The primary null hypothesis is that the means are equal versus the alternative hypothesis that the means are different. We plan to perform the comparison using a two-sided Student's t-test with α=5%. The power of the study to detect the difference described below has been set at 90%.; One hundred twenty patients candidate to receive neoadjuvant or adjuvant CT for early BC will be randomized 1:1 to receive either epirubicin-cyclophosphamide (EC) or docetaxel (Taxotere) -cyclophosphamide (TC) for 4 cycles.

Trial Locations

Locations (1)

Institut Jules Bordet; 🇧🇪 Brussels, Belgium