This study investigates the effect of high-dose alkylating chemotherapy compared with standard chemotherapy as part of a multimodality treatment approach in patients with oligo-metastatic breast cancer harboring homologous recombination deficiency.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
74
tandem intermediate-dose alkylating therapy: carboplatin 800 mg/m2, thiotepa 240 mg/m2, and cyclophosphamide 3000 mg/m2) with PBPC-reinfusion.
* chemotherapy naïve;three cycles of docetaxel, doxorubicin, and cyclofosfamide * chemotherapy naïve;1 cycle of dose-dense Adriamycin and cyclophosphamide followed by 4 cycles of carboplatin and paclitaxel * previously received anthracyclines without taxanes;three cycles of carboplatin and paclitaxel * previously received anthracyclines and taxanes;three cycles of carboplatin and gemcitabine
NKI-AVL
Amsterdam, Netherlands
Event free survival
time from randomization to local recurrence, second primary, distant recurrence or death, whichever comes first
Time frame: assessed up to 120 months
Difference in median overall survival
time from randomization to death from any cause
Time frame: assessed up to 120 months
Difference in percentage of patients with grade >2 hematologic toxicity (CTCAE v4.0)
Difference in percentage of patients with grade \>2 hematologic toxicity (CTCAE v4.0)
Time frame: 6 months after start of treament
Difference in percentage of patients with grade >2 non-hematologic toxicity (CTCAE v4.0)
Difference in percentage of patients with grade \>2 non-hematologic toxicity (CTCAE v4.0)
Time frame: 6 months after start of treatment
Difference in quality of life (EORTC QLQ-C30 v 3.0)
Difference in quality of life (EORTC QLQ-C30 v 3.0)
Time frame: 6 and 12 months post treatment
Difference in event free survival
o Difference in event free survival in the subgroups based on: * Estrogen receptor status; * Origin of the oligo-metastatic lesion (lymphnodes versus bone versus visceral metastases); * Primary or recurrent oligometastatic breast cancer; * BRCA1 mutation/profile or BRCA2 mutation/profile; * HRD based on BRCA1 or BRCA2 mutation and HRD based on BRCA1-like and/or BRCA2-like profile.
Time frame: assessed up to 120 months
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