Overview

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