Status:
COMPLETED
Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer - Triple Negative Breast Cancer
Lead Sponsor:
West German Study Group
Collaborating Sponsors:
Celgene
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2025
Estimated Enrollment :
336 Patients enrolled
Trial Details
Trial ID
NCT01815242
Start Date
June 1 2013
End Date
January 15 2025
Last Update
February 27 2025
Active Locations (1)
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1
Ev. Krankenhaus Bethesda Brustzentrum Niederrhein, Mönchengladbach, Germany
Mönchengladbach, Germany, 41061