| Eligibility |
General Inclusion Criteria for ADAPT:
- Female patients, age at diagnosis 18 years and above (consider patients at 70 years
and above for ADAPT Elderly)
- Candidate for chemotherapy on the basis of conventional criteria
- Histologically confirmed unilateral primary invasive carcinoma of the breast
- Clinical T1 - T4a-c
- 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%
- 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
- Patients must qualify for neoadjuvant treatment
- LVEF > 50%; LVEF within normal limits of each institution measured by echocardiography
and normal ECG (within 42 days prior to chemotherapy)
- Laboratory requirements :
- Leucocytes = 3.5 x 109/L
- Platelets = 100 x 109/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)
Additional inclusion criteria ADAPT Elderly:
- = 70 years old
- Charlson scale = 2
- HR+/HER2- disease: if RS and sequential testing are available N0-1/RS 12-25/poor
response or N0-1/RS =26
- All G3 with Ki-67 =40% in tumors >1cm
- All N2
- All TN
- All subtypes
General Exclusion Criteria for ADAPT:
- 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, 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 clinical
trial with any investigational not marketed drug within 30 days prior to study entry
(concurrent participation in non-interventional post authorization safety studies not
influencing the primary study endpoints is allowed, e.g. WSG PROTROCA for evaluation
of primary/secondary G-CSF prophylaxis)
- Male breast cancer
- Sequential breast cancer
- Reasons indicating risk of poor compliance
- Patient not able to consent
Additional Exclusion Criteria ADAPT Elderly:
- Known polyneuropathy = grade 2
- Severe and relevant co-morbidity that would interact with the application of cytotoxic
agents or the participation in the study
- Inadequate organ function (e.g. hepatic impairment, pulmonary disease, etc.)
- Uncompensated cardiac function (current unstable ventricular arrhythmia requiring
treatment, history of symptomatic CHF NYHA classes II-IV), history of myocardial
infarction or unstable angina pectoris within 12 months of enrollment, history of
severe hypertension, CAD - coronary artery disease)
- Severe dyspnea
- Pneumonitis
- Abnormal blood values:
- Thrombocytopenia > CTCAE grade 1
- Increases in ALT/AST > CTCAE grade 1
- Hypokalaemia > CTCAE grade 1
- Neutropenia > CTCAE grade 1
- Anaemia > CTCAE grade 1
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