NcXHF

PRECISION MEDICINE FOR BREAST CANCER
Chemoresistant Triple-Negative Breast Cancer) trial. This is
a single-arm, phase II, open-label, preoperative study of a
small-molecule NOTCH inhibitor that is administered for 9
days after completion of neoadjuvant chemotherapy in
patients with triple-negative breast cancer that is
chemotherapy-resistant.
CONCLUSION
To the present day, great progress has been made in the molecular
profıling of breast cancer, with an expanding array of
molecular aberrations being identifıed. The subsequent development
of experimental targeted agents promises to
improve cancer treatment for patients bearing specifıc molecular
aberrations. A major challenge is the assessment of
the functional signifıcance of such aberrations and the verifıcation
of their relevance as predictors of sensitivity to their
matched targeted agents under development. The latter can
be achieved through well-conducted clinical trials that match
several specifıc genotypes of the disease with a number of targeted
agents. To this end, innovative study designs must
be implemented to expedite anticancer drug development.
Such studies need to be coupled with next-generation
molecular profıling techniques that have been validated to
secure fındings’ reproducibility. The one-size-fıts-all paradigm
of conventional study design must be abandoned,
and the approval strategies revisited in some cases. More
extensive collaboration between academia around the
world, regulatory agencies, and pharmaceutical companies
developing new anticancer compounds is becoming a
necessity for these innovative study designs to be successfully
implemented.
Disclosures of Potential Conflicts of Interest
Relationships are considered self-held and compensated unless otherwise noted. Relationships marked “L” indicate leadership positions. Relationships marked “I” are those held by an immediate
family member; those marked “B” are held by the author and an immediate family member. Institutional relationships are marked “Inst.” Relationships marked “U” are uncompensated.
Employment: None. Leadership Position: None. Stock or Other Ownership Interests: None. Honoraria: None. Consulting or Advisory Role: Martine
J. Piccart-Gebhart, Amgen, Astellas, AstraZeneca, Bayer, Eli Lilly, Invivis, MSD, Novartis, Pfizer, Roche-Genentech, sanofi Aventis, Symphogen, Synthon,
Verastem. Speakers’ Bureau: None. Research Funding: Martine J. Piccart-Gebhart, Amgen (Inst), Astellas (Inst), AstraZeneca (Inst), Bayer (Inst), Eli Lilly
(Inst), Invivis (Inst), MSD (Inst), Novartis (Inst), Pfizer (Inst), Roche-Genentech (Inst), Sanofi Aventis (Inst), Symphogen (Inst), Synthon (Inst), Verastem (Inst).
Patents, Royalties, or Other Intellectual Property: None. Expert Testimony: None. Travel, Accommodations, Expenses: None. Other Relationships:
None.
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