Neo Adjuvant Chemotherapy in Triple Negative Breast Cancer (neo-TN)
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Neo adjuvant, Triple negative, primary tumor over 2 cm and/or positive lymphnodes
Eligibility Criteria
Inclusion Criteria:
- Proven infiltrating breast cancer with either a primary tumor over 2 cm in size (MRI or ultrasound examination) and/or cytologically proven spread to the axillary lymph nodes.
- Patients with 'locally advanced breast cancer' are consequently eligible, including those with ipsilateral supraclavicular lymph node metastases.
- The tumor must be HER2/neu-negative (either score 0 or 1 at immunohistochemistry or negative at in situ hybridization [CISH or FISH] in case of score 2 or 3 at immunohistochemistry).
- The tumor must be Estrogen receptor (ER) -negative (< 10% nuclear staining at IHC) and Progesterone receptor (PR) -negative (< 10% nuclear staining at IHC). However, the rare tumors that are ER-negative and PR-positive will be eligible, if this pattern of hormone receptor expression can be verified in the NKI-AVL reference pathology lab.
- Age 18 to 59 years; patients older than 59 years may be included when considered 'biologically 59 years or younger' (as judged by the investigator).
- Performance status: WHO 0 or I.
- Adequate bone marrow function (W.B.C. count > 3.0 x 109/l, platelets > 100 x 109/l).
- Adequate hepatic function (ALAT, ASAT and bilirubin < 2 x upper limit of normal, or minor abnormalities of these tests judged to be of no consequence by the study coordinator).
- Adequate renal function (creatinine clearance > 60 ml/min).
- Informed consent
Exclusion Criteria:
- Previous radiation therapy or chemotherapy.
- Other malignancy except carcinoma in situ, unless the other malignancy was treated 5 or more years ago with curative intent without the use of chemotherapy or radiation therapy.
- Pregnancy or breast feeding.
- Evidence of distant metastases. Staging examinations must have included a chest roentgenogram, an ultrasound examination of the liver and an isotope bone scan. Abnormal uptake on the isotope bone scan can only be accepted if bone metastases were excluded by MRI
Sites / Locations
- Medisch Centrum Alkmaar
- NKI-AVL
- OLVG
- Reinier de Graaf Groep
- Medisch Centrum Haaglanden
- Deventer Ziekenhuis
- Albert Schweitzer ziekenhuis
- Ziekenhuis Gelderse Vallei
- Kennemer Gasthuis
- Atrium Medisch Centrum Parkstad
- Spaarne Ziekenhuis
- LUMC
- Maasstad ziekenhuis
- Isala Klinieken
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Active Comparator
Active Comparator
Active Comparator
Active Comparator
HRD; 1x ddAC, 2x tCTC
HRD; 3x CP
non-HRD;3x CP
non-HRD; response; 3x ddAC
non-HRD; response; 3x CP
HRD positive tumors; irrespective of response; - a fourth course of AC followed by Peripheral Blood Progenitor Cell (PBPC) harvest and tandem intermediate-dose alkylating therapy (miniCTC, carboplatin 800 mg/m2, thiotepa 250 mg/m2, and cyclophosphamide 3000 mg/m2) with PBPC-reinfusion.
HRD tumors; any response to 3x ddAC; 3 courses of CP
non-HRD tumors; unfavourable response to 3x ddAC; 3 courses of Carboplatin and Paclitaxel
non-HRD tumors; favourable response to 3x ddAC; 3 more courses of ddAC
non-HRD tumors; favourable response to 3x ddAC; 3 courses of Carboplatin and Paclitaxel