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INFORM Extended

Primary Objectives:
The goal of the current trial is to collect information about post-surgery adjuvant therapy (systemic and radiation), breast cancer recurrences (local and distant) and death for patients who completed the INFORM trial (DF-HCC 12-258; TBCRC 031) in order to determine if:
1. 3-yr recurrence-free survival (RFS) is significantly better for germline BRCA mutation (gBRCAm) carriers with newly diagnosed HER2-negative breast cancer allocated to cisplatin vs. AC (doxorubicin and cyclophosphamide) chemotherapy as part of the INFORM trial.
2. 3-yr RFS is significantly improved for gBRCAm carriers who achieved pathologic complete response (pCR) as part of the INFORM trial (both arms of the INFORM trial combined) compared with those who did not.
Secondary Objective:
To evaluate whether the predictors of pathologic response we are evaluating in the INFORM trial (TILs, ptDNA, BRCA reversion mutations, homologous recombination function assays such as RAD51C foci assessments) are also predictive of 3-yr recurrence-free survival.

Protocol Number: 042101
Phase: N/A
Applicable Disease Sites: Breast
Principal Investigator: Deborah Toppmeyer M.D.
Scope: National
Participating Institutions:
  • Rutgers Cancer Institute of New Jersey

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