Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer - Triple Negative Breast Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Women's Cancer Study Group GmbH
With
Celgene
Age
18–75
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
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)
You may not be if
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
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
Clareo Health | Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer - Triple Negative Breast Cancer
