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Table 1 Clinical characteristics and response

From: A randomized phase I trial of nanoparticle albumin-bound paclitaxel with or without mifepristone for advanced breast cancer

Patient

Cycle 1 randomization

# Prior Txs for MBC

Prior taxanea

Taxane refractoryb

Best response

Dose level 1: nab-paclitaxel 100 mg/m2 + mifepristone 300 mg

 1

Placebo

0

N

N/A

PR

 2

Mifepristone

0

Y

N

PD

 3

Placebo

2

Y

N

PD

 4

Mifepristone

2

Y

N

CR

Dose level −1: nab-paclitaxel 80 mg/m2 + mifepristone 300 mg

 5

Mifepristone

0

Y

N

PR

 6

Mifepristone

0

Y

Y

SDc

 7

Placebo

0

Y

N

CR

 8

Placebo

3

Y

N

PR

 9

Mifepristone

3

Y

N

PD

  1. PR partial response, PD progressive disease, CR complete response, SD stable disease, MBC metastatic breast cancer, Txs treatments, n/a not available, Y yes, N no
  2. aIn the adjuvant setting, with exception of patient 4 who received taxane in both adjuvant and metastatic disease setting
  3. bDefined as recurrence or progression within 6 months of taxane exposure
  4. cUnconfirmed response, all other responses confirmed
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