Breast Cancer
Conditions
Brief summary
The trial will evaluate the optimal treatment with nab-paclitaxel in combination with either carboplatin or gemcitabine for patients with triple negative breast cancer.
Interventions
DRUGnab-Paclitaxel
DRUGGemcitabine
DRUGCarboplatin
Sponsors
Celgene
West German Study Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Female patients, age at diagnosis 18 years and above (consider patients at 70 years and above for ADAPT Elderly) * Histologically confirmed unilateral primary invasive carcinoma of the breast * Clinical T1 - T4 (except inflammatory breast cancer) * All clinical N (cN) * No clinical evidence for distant metastasis (M0) * Known HR status and HER2 status (local pathology) * Tumor block available for central pathology review * Performance Status ECOG \< 1 or KI \> 80 % * Negative pregnancy test (urine or serum) within 7 days prior to start of induction treatment in premenopausal patients * Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements * The patient must be accessible for treatment and follow-up Additional Inclusion Criteria for patients receiving chemotherapy: * Laboratory requirements for patients receiving neoadjuvant chemotherapy (within 14 days prior to induction treatment): * Leucocytes \>= 3.5 10\^9/L * Platelets \>= 100 10\^9/L * Hemoglobin \>= 10 g/dL * Total bilirubin \<= 1 x ULN * ASAT (SGOT) and ALAT (SGPT) \<= 2.5 x UNL * Creatinine \<= 175 µmol/L (2 mg/dl) * LVEF within normal limits of each institution measured by echocardiography and normal ECG (within 42 days prior to induction treatment)
Exclusion criteria
* Known hypersensitivity reaction to the compounds or incorporated substances * Prior malignancy with a disease-free survival of \< 10 years, except curatively treated basalioma of the skin or pTis of the cervix uteri * Non-operable breast cancer including inflammatory breast cancer * Previous or concurrent treatment with cytotoxic agents for any reason after consultation with the sponsor * Concurrent treatment with other experimental drugs. Participation in another interventional clinical trial with or without any investigational not marketed drug within 30 days prior to study entry * Male breast cancer * Concurrent pregnancy; patients of childbearing potential must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment * Breast feeding woman * Sequential breast cancer * Reasons indicating risk of poor compliance * Patients not able to consent Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison: pCR in nab-paclitaxel/carboplatin vs. nab-paclitaxel/gemcitabine | After 12 weeks of therapy | pCR will be measured after 12 weeks of randomized treatment. |
| Comparison: pCR in responders vs. non-responders | After 12 weeks of therapy | pCR will be measured after 12 weeks of randomized treatment. |
Countries
Germany
Outcome results
None listed