Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer - Triple Negative Breast Cancer
This trial is active, not recruiting.
|Treatments||nab-paclitaxel, gemcitabine, carboplatin|
|Sponsor||West German Study Group|
|Start date||June 2013|
|End date||March 2015|
|Trial size||336 participants|
|Trial identifier||NCT01815242, WSG-AM06 / ADAPT TN|
The trial will evaluate the optimal treatment with nab-paclitaxel in combination with either carboplatin or gemcitabine for patients with triple negative breast cancer.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
nab-Paclitaxel + gemcitabine
nab-Paclitaxel + carboplatin
Comparison: pCR in nab-paclitaxel/carboplatin vs. nab-paclitaxel/gemcitabine
time frame: After 12 weeks of therapy
Comparison: pCR in responders vs. non-responders
time frame: After 12 weeks of therapy
Female participants from 18 years up to 75 years old.
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 Exclusion Criteria for patients receiving chemotherapy: - Known polyneuropathy ≥ grade 2 - Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study including acute cystitis and ischuria and chronic kidney disease - Uncompensated cardiac function - Inadequate organ function including: - Leucocytes < 3.5 x 10^9/l - Platelets < 100 x 10^9/l - Bilirubin above normal limits - Alkaline phosphatase > 5 x UNL - ASAT and/or ALAT associated with AP > 2.5 x UNL
|Official title||Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer - Triple Negative Breast Cancer|
|Principal investigator||Nadia Harbeck, Prof. Dr.|
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