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Clinical study for patients with breast cancer that has spread to other parts of the body and that does not respond to hormonal or anti-HER2 therapy ('triple negative disease'), comparing a chemothera...

Update Il y a 4 ans
Reference: EUCTR2013-000113-20

Clinical study for patients with breast cancer that has spread to other parts of the body and that does not respond to hormonal or anti-HER2 therapy ('triple negative disease'), comparing a chemotherapy treatment (carboplatin + gemcitabine) with an experimental treatment of nab-paclitaxel plus chemotherapy (carboplatin OR gemcitabine)

Woman Man

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Extract

- Phase 2: evaluate the benefit and risk profiles of the two nab-paclitaxel experimental arms and identify the nab-paclitaxel combination that will be used in the Phase 3. - Phase 3: compare the progression-free survival (PFS) of nab-paclitaxel plus carboplatin to gemcitabine/carboplatin in subjects with TNMBC, as assessed by independent blinded radiologist(s) using RECIST 1.1 guidelines.

Inclusion criteria

  • ER, PgR, and HER2 negative (triple negative) metastatic breast cancer

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