Cyclophosphamide and Docetaxel or Doxorubicin in Treating Women With Newly Diagnosed Breast Cancer That Can Be Removed by Surgery
|ClinicalTrials.gov Identifier: NCT00801411|
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : December 3, 2008
Last Update Posted : June 17, 2009
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, docetaxel, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known which chemotherapy regimen is more effective in treating breast cancer.
PURPOSE: This randomized phase II trial is studying cyclophosphamide given together with docetaxel to see how well it works compared with cyclophosphamide given together with doxorubicin in treating women with newly diagnosed breast cancer that can be removed by surgery.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: cyclophosphamide Drug: docetaxel Drug: doxorubicin hydrochloride||Phase 2|
- To evaluate tumor pathological complete response rate after neoadjuvant cyclophosphamide in combination with docetaxel vs doxorubicin hydrochloride in women with operable clinically node-negative breast cancer and normal topoisomerase IIα expression.
- To assess tumor clinical and pathological overall response rates in patients treated with these regimens.
- To assess the safety and toxicity of these regimens.
- To assess disease-free survival and overall survival of these patients.
- To assess the efficacy of short-course (3 days) filgrastim (G-CSF) as primary and secondary prophylaxis against febrile neutropenia in patients receiving docetaxel and cyclophosphamide.
OUTLINE: This is a multicenter study.
Patients are stratified according to hormone receptor status (estrogen receptor [ER]- or progesterone receptor [PR]-positive vs ER- and PR-negative) and T stage (T2 vs T3). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cyclophosphamide IV and docetaxel IV over 1 hour on day 1.
- Arm II: Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1.
In both arms, treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of neoadjuvant chemotherapy, all patients undergo surgery.
Tumor specimens obtained prior to neoadjuvant chemotherapy are analyzed for topoisomerase IIα gene and protein expression by IHC and FISH. Tissue samples are also collected at surgery for future studies.
After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||318 participants|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Phase 2 Study of Neoadjuvant Docetaxel and Cyclophosphamide Compared to Doxorubicin and Cyclophosphamide in Operable Node Negative Breast Cancer With Normal Topoisomerase IIα Expression|
|Study Start Date :||October 2008|
Experimental: Arm I
Patients receive cyclophosphamide IV and docetaxel IV over 1 hour on day 1.
Given IVDrug: docetaxel
Active Comparator: Arm II
Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1.
Given IVDrug: doxorubicin hydrochloride
- Pathological complete response rate
- Clinical and pathological overall response rate
- Toxicity as assessed by NCI CTCAE v3.0
- Overall survival
- Disease-free survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00801411
|Singapore General Hospital||Recruiting|
|Singapore, Singapore, 169608|
|Contact: Wong Chow Yin 65-6222-3322|
|National Cancer Centre - Singapore||Recruiting|
|Singapore, Singapore, 169610|
|Contact: Wong Nan Soon, MBBS, MRCP, FAMS 65-6-436-8088|
|Principal Investigator:||Wong Nan Soon, MBBS, MRCP, FAMS||National Cancer Centre, Singapore|