A Randomized Controlled Study of Docetaxel Monotherapy or Docetaxel and DOXIL for the Treatment of Advanced Breast Cancer - DOXIL BCA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000617-19-HU

Enrollment

720

Registered

2004-07-21

Start date

2004-09-13

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

Trade Name: TAXOTERE 20mg/0.5ml koncentrÃ¡tum infÃºziÃ³hoz Product Name: Docetaxel 20mg/0.5ml vials Product Code: injection concentrate Pharmaceutical Form: Solution for infusion INN or Proposed INN:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Female - Age 18 years or older - Advanced breast cancer (Stage IIIb, not amenable to surgical treatment or Stage IV), for which there is histologic or cytologic proof of malignancy - Presence of measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) provided in Attachment 4, RECIST Criteria Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - More than 1 prior cytotoxic chemotherapy regimen for advanced breast cancer (this does not include treatment given in the neoadjuvant or adjuvant setting) - Treatment of advanced breast cancer with an anthracycline, paclitaxel, docetaxel, vinorelbine, or vinblastine (prior treatment of advanced breast cancer with 1 regimen that includes alkylating agents or antimetabolite agents is acceptable)

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to evaluate whether the overall survival for the DOXIL/CAELYX and docetaxel treatment group is superior to that of the group treated with docetaxel monotherapy;Secondary Objective: Secondary objectives are to compare the objective response (complete response plus partial response) rate, time to progression, and safety profile between the treatment groups, and to explore the impact of treatment on quality of life experienced by the subjects, by using the Functional Assessment of Cancer Therapy-Breast(FACT-B). Pharmacogenomic studies will evaluate the relationship between genes that might increase the likelihood of anthracycline-induced cardiotoxicity and clinical events observed during treatment on the study.;Primary end point(s): Primary End point Overall survival: the interval between the date of randomization and the subject's death from any cause.	—

Measure

Time frame

Main Objective: The primary objective of this study is to evaluate whether the overall survival for the DOXIL/CAELYX and docetaxel treatment group is superior to that of the group treated with docetaxel monotherapy;Secondary Objective: Secondary objectives are to compare the objective response (complete response plus partial response) rate, time to progression, and safety profile between the treatment groups, and to explore the impact of treatment on quality of life experienced by the subjects, by using the Functional Assessment of Cancer Therapy-Breast(FACT-B). Pharmacogenomic studies will evaluate the relationship between genes that might increase the likelihood of anthracycline-induced cardiotoxicity and clinical events observed during treatment on the study.;Primary end point(s): Primary End point Overall survival: the interval between the date of randomization and the subject's death from any cause.

—

Countries

Estonia, Germany, Hungary, Italy, Latvia, Lithuania, Spain, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026