Epirubicin or Not in Patients With TOP2A (Topoisomerase (DNA) II Alpha (170kD)) Normal Early Breast Cancer

Phase 3

Completed

• Conditions: Breast Neoplasms
• Interventions: Drug: docetaxel, cyclophosphamide; Drug: Epirubicin, cyclophosphamide and docetaxel

• Registration Number: NCT00689156
• Lead Sponsor: Danish Breast Cancer Cooperative Group

Brief Summary

The Danish Breast Cancer Cooperative Group (DBCG) wishes to clarify if recurrence-free and overall life expectancy is longer after docetaxel and cyclophosphamide compared to epirubicin and cyclophosphamide followed by docetaxel in patients with TOP2A normal and operable breast cancer.

Detailed Description

In DBCG trial 89D we in more than 1,200 patients showed that substitution in CMF chemotherapy of methotrexate with epirubicin improves survival for patients with primary and operable breast cancer. In a retrospective evaluation we have also shown that approximately 20% of all patients in 89D have tumors with numerical changes of the TOP2A gene, and that only patients with abnormal TOP2A benefit from epirubicin. In the current trial the DBCG wishes to clarify if recurrence-free and overall life expectancy is longer after docetaxel and cyclophosphamide compared to epirubicin and cyclophosphamide followed by docetaxel in patients with TOP2A normal and operable breast cancer.

Study Timeline

• Study First Submitted: 2008-05-29
• Study Start: 2008-06
• Study First Submitted QC: 2008-06-02
• Study First Posted: 2008-06-03
• Status Verified: 2013-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2015

Inclusion Criteria

1. Signed informed consent
2. Histologically confirmed invasive breast carcinoma which has been micro-radical removed by breast preserving surgery or mastectomy according to DBCG's guideline
3. TOP2A normal tumor (score of 0.8 - 2.0)

Exclusion Criteria

1. Pregnancy or breast-feeding
2. Earlier medical cancer treatment, including docetaxel, epirubicin or cyclophosphamide.
3. Distant metastases or bilateral breast cancer (excluded after checking by means of chest radiography, bilateral mammography and normal blood samples as a minimum).
4. Other active, malign disease in the latest 5 years, except for adequately treated and cured carcinoma in situ cervices uteri or non-melanoma skin cancer.
5. Comorbidity score > 3 (patients with a score of 1-2 start at dose level -1).
6. Treatment with a non-approved product or test product in the latest 30 days.
7. Known severe hypersensitivity to docetaxel, epirubicin or cyclophosphamide or auxiliary agents in these products.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regimen 2	docetaxel, cyclophosphamide	Docetaxel 75 mg/m2 plus cyclophosphamide 600 mg/m2 intravenously day 1 every 3 weeks times six
Regimen 1	Epirubicin, cyclophosphamide and docetaxel	Epirubicin 90 mg/m2 plus cyclophosphamide 600 mg/m2 intravenously day 1 every 3 weeks times three followed by docetaxel 100 mg/m2 intravenously day 1 every 3 weeks times three

Primary Outcome Measures

Name	Time	Method
IDFS; invasive disease-free survival	Within 10-yeras

Secondary Outcome Measures

Name	Time	Method
Overall survival	Life-long observation
DDFS; distant disease-free survival	Within 10-years
Serious adverse events	Within 10-years

Trial Locations

Locations (13)

Dept. of Oncology; Herlev Hospital; 🇩🇰 Herlev, Denmark

Dept. of Oncology; Nordsjællands Hospital Hillerød; 🇩🇰 Hillerød, Denmark

Dept. of Oncology; Aalborg Sygehus; 🇩🇰 Aalborg, Denmark

Dept. of Oncology; Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Dept. of Oncology; Sydvestjysk Sygehus Esbjerg; 🇩🇰 Esbjerg, Denmark

Dept. of Oncology; Odense University Hospital; 🇩🇰 Odense, Denmark

Dept. of Oncology; Sygehus Syd Næstved; 🇩🇰 Næstved, Denmark

Dept. of Oncology; Regionshospitalet Herning; 🇩🇰 Herning, Denmark

Dept. of Oncology; Sygehus Øst Roskilde; 🇩🇰 Roskilde, Denmark

Dept. of internal medicine; Bornholms Hospital; 🇩🇰 Rønne, Denmark

Dept. of Oncology; Vejle Sygehus; 🇩🇰 Vejle, Denmark

Dept. of Oncology; Århus Sygehus; 🇩🇰 Århus, Denmark

Dept. of Oncology; Regionshospitalet Viborg; 🇩🇰 Viborg, Denmark