Study Comparing Concomitant Docetaxel + Gemcitabine to Sequential Therapy of Docetaxel Followed by Gemcitabine

Phase 3

Completed

Brief Summary: The purpose of this study is to compare the Time To Disease Progression (TTDP) between those patients with unresectable, locally recurrent or metastatic breast cancer who are treated with concomitant Docetaxel plus Gemcitabine to those patients treated with sequential therapy of Docetaxel followed by Gemcitabine.

Detailed Description: This is an open, multicenter, two-armed Phase III study

Patients will be randomized to either of the following two arms:

Arm A (concomitant arm), Gemcitabine 1000 mglm2 will be administered intravenously on Days 1 and 8, repeated on Day 22. Docetaxel 75 mg/m2 will be given on Day 8 (before Gemcitabine), repeated on Day 22. This 3-week schedule defines a cycle of treatment for this arm. Overall 8 cycles will be administered.

Arm B (sequential arm) four cycles of Docetaxel 100 mg/m2 an Day 1, repeated an Day 22, followed by four cycles of Gemcitabine 1250 mg/m2 an a Day 1 and 8, repeated an Day 22, will be given. Both drugs will be administered in a 3-week schedule.

Bimonthly follow-up for patients without confirmed disease progression until progression of disease. Long-term follow-up for patients with confirmed disease progression will be done in 4 intervals.

For therapy control frequent blood chemistry and hematology, physical examination, weight control, potential adverse events and imaging procedures (CT, X-ray, MRI, Bone scan) am foreseen.

Recruitment & Eligibility

Inclusion Criteria

Patients with histologic or cytologic diagnosis of breast cancer with evidence of unresectable, locally recurrent, or metastatic disease.
Females, 18 to 75 years of age
pre-treated with ONE anthracyclines containing chemotherapy either in neoadjuvant/adjuvant or 1st line metastatic setting will be enrolled into the study
Patients with clinically measurable lesions will be enrolled in this study. Measurability is determined according to RECIST criteria
Performance status of 70 or higher on the Karnofsky Performance Scale
Adequate bone marrow reserve
Adequate liver function
Adequate renal function
Informed consent form patient or guardian
Childbearing potential either terminated by surgery, radiation, or menopause, use of an approved contraceptive method

Exclusion Criteria

Active infection (at the discretion of the investigator).
Known or suspected brain metastases requiring steroid or radiation treatment.
Pregnancy (recent negative urine pregnancy test for pre-menopausal patients mandatory)
Breast-feeding
Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin).
Bone metastases, pleural effusion, or ascites as the only site of disease.
Bone marrow transplantation or autologous stern cell infusion following high-dose chemotherapy for adjuvant or metastatic disease.

Arm && Interventions

Group	Intervention	Description
Gemcitabine, Docetaxel	Gemcitabine, Docetaxel	Arm A (concomitant arm), Gemcitabine 1000 mglm2 will be administered intravenously on Days 1 and 8, repeated on Day 22. Docetaxel 75 mg/m2 will be given on Day 8 (before Gemcitabine), repeated on Day 22. This 3-week schedule defines a cycle of treatment for this arm. Overall 8 cycles will be administered.
Gemcitabine, Docetaxel	Docetaxel	Arm A (concomitant arm), Gemcitabine 1000 mglm2 will be administered intravenously on Days 1 and 8, repeated on Day 22. Docetaxel 75 mg/m2 will be given on Day 8 (before Gemcitabine), repeated on Day 22. This 3-week schedule defines a cycle of treatment for this arm. Overall 8 cycles will be administered.
Docetaxel	Docetaxel	Arm B (sequential arm) four cycles of Docetaxel 100 mg/m2 an Day 1, repeated an Day 22, followed by four cycles of Gemcitabine 1250 mg/m2 an a Day 1 and 8, repeated an Day 22, will be given. Both drugs will be administered in a 3-week schedule.

Primary Outcome Measures

Name	Time	Method
to compare the Time To Disease Progression between those patients with unresectable, locally recurrent or metastatic breast cancer who are treated with concomitant Docetaxel plus Gemcitabine to those patients treated with sequential therapy of Doc

Secondary Outcome Measures

Name	Time	Method
Overall response rate
Response duration
Overall survival
Characterize changes in performance status, patient-reported pain, and disease-related symptoms in each arm
Characterize the nature of the toxicities experienced in each arm

Locations (17): Rizk Hospital
🇱🇧
Beirut, Lebanon
Nomocnica Sv. Alzbety, Narodny Onkologicky Ustav
🇸🇰
Bratislava, Slovakia
Rambam Medical Center, Oncol. Dep
🇮🇱
Haifa, Israel
Tel Aviv Sourasky Medical Center, Div of Oncology
🇮🇱
Tel Aviv, Israel
"Sheba" Medical Center, Dep of Oncology
🇮🇱
Tel Hashomer, Israel
American University of Beirut, Medical Center
🇱🇧
Beirut, Lebanon
2. Med. Abteilung - LKH-Steyr
🇦🇹
Steyr, Austria
FN Hradec Kralove
🇨🇿
Hradec Kralove, Czech Republic
Charles University Prague, Dep of Oncology
🇨🇿
Prague, Czech Republic
Cancer Center Plovdiv
🇧🇬
Plovdiv, Bulgaria
Intere IV Krankenhaus Wels
🇦🇹
Wels, Austria
Hanusch KrankenhausHämatologisch-Onkologisches Zentrum
🇦🇹
Vienna, Austria
SBALO National Oncology Center
🇧🇬
Sofia, Bulgaria
FN U sv. Anny
🇨🇿
Brno, Czech Republic
Nemocnice Ceske Budejovice
🇨🇿
Ceske, Czech Republic
FN Bulovka
🇨🇿
Prague, Czech Republic
Klinika Onkologii CMuJ
🇵🇱
Krakow, Poland