Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer - Triple Negative Breast Cancer

• Status: Unknown status
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: West German Study Group
• Collaborators: Celgene; Celgene Corporation
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Gemcitabine; Paclitaxel

Criteria

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