Simultaneous Study of Gemcitabine-Docetaxel Combination adjuvant treatment, as well as Extended Bisphosphonate and Surveillance-Trial SUCCESS-Trial - SUCCESS
- Conditions
- This is an open-label, multicenter, 2x2 factorial design, randomized controlled, Phase III study comparing the time to recurrence after randomisation in patients with early primary breast cancer.
- Registration Number
- EUCTR2005-000490-21-DE
- Lead Sponsor
- 1. Frauenklinik der LMU- Innenstadt
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
Patients may be included in the study only if they meet all the following criteria:
1. Primary epithelial invasive carcinoma of the breast pT1-4, pM0
2. Histopathological proof of axillary lymph node metastases (pN1-3) or high risk node negative, defined as: pT>2 or histopathological grade 3, or age < 35 and negative hormone receptor
3. Complete resection the primary tumor with margins of resection free of invasive carcinoma not more than 6 weeks ago
4. Females >18 years of age
5. Performance Status <2 on ECOG-Scale
6. Estimated life expectancy of at least 32 weeks
7. Adequate bone marrow reserve: leucocytes >3.0 x 109/l and platelets >100 x 109/l
8. Bilirubin within one fold of the reference laboratory’s normal range, ASAT (SGOT), ALAT (SGPT) and AP within 1.5 fold of the reference laboratory’s normal range for patients
9. Intention of regular follow up visits for the duration of the study
10. Ability to understand the nature of the study and to give written informed consentconsent
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) yes
F.1.3.1 Number of subjects for this age range
1. Inflammatory breast cancer
2. Previous or concomitant cytotoxic or other systemic antineoplastic treatment which is not part of this study
3. History of treatment or disease affecting bone metabolism (e.g., Paget’s disease, primary hyperparathyroidism)
4. Prior treatment with bisphosphonates within the last 6 months
5. Severe renal insufficiency as evidenced by creatinine clearance < 30 ml/min as calculates using the Cockcroft-Gault-Formula:CrCl: 140- Alter (Jahre) x Gewicht (kg) x 0,85/ 75 x Serum-Kreatinin (mg/dl)
6. A second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
7. Cardiomyopathy with impaired ventricular function (NYHA > II), cardiac arrythmias influencing LVEF and requiring medication, history of myocardial infarction or angina pectoris within the last 6 months, or arterial hypertension not being controlled by medication
8. Any known hypersensitivity against docetaxel, epirubicin, cyclophosphamide, fluorouracil, gemcitabine or any other medication included in the study protocol
9. Use of any investigational agent within 3 weeks prior to inclusion
10. Patients in pregnancy or breast feeding (in premenopausal women anticonception has to be assured)
11. Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
12. Recent (within 6 weeks) or planned dental or jaw surgery (e.g..extraction, implants)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method