NeoSphere

NCT00545688 📎

Regimen

Experimental
4 arms: (A) trastuzumab + docetaxel; (B) pertuzumab + trastuzumab + docetaxel; (C) pertuzumab + trastuzumab (no chemo); (D) pertuzumab + docetaxel. 4 cycles neoadjuvant.
Control
Arm A (trastuzumab + docetaxel) serves as the standard comparator.

Population

HER2-positive operable, locally advanced or inflammatory breast cancer >= 2 cm, previously untreated.

Key finding

NeoSphere first demonstrated that adding pertuzumab to trastuzumab + docetaxel nearly doubles pCR rate in HER2+ breast cancer. Key data supporting FDA accelerated approval of neoadjuvant pertuzumab (2013) -- the first ever neoadjuvant-indication approval.

Source: PMID 22153890

Timeline

  • Publication: 2012 Jan

Guideline citations

  • NCCN BREAST