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Table 1 Summary of randomized trials testing new drugs in Her2-overexpressing breast cancers

From: Strategies to overcome trastuzumab resistance in HER2-overexpressing breast cancers: focus on new data from clinical trials

Drugs

Targets

Study

Identifier number

Phase

Setting

Primary endpoint

Therapy

Results

 

Pertuzumab

HER2/3

CLEOPATRA

NCT00567190

Phase III

MBC/locally recurent/unresectable

PFS

Trastuzumab + docetaxel + pertuzumab

18.7 months

HR 0.69; 95% CI 0.58-0.81; P <0.001

     

in first line

 

trastuzumab + docetaxel + placebo

12.4 months

 
  

NEOSPHERE

NCT00545688

Phase II

Neo adjuvant

pCR

Trastuzumab + docetaxel

29.0%

 
       

Trastuzumab + pertuzumab + docetaxel

45.8%

P = 0.0141

       

Pertuzumab + docetaxel

24.0%

 
       

Trastuzumab + pertuzumab

16.8%

 

T-DM1

HER2

EMILIA

NCT00829166

Phase III

MBC

PFS

T-DM1

9.6 months

HR 0.65; 95% CI 0.55-0.77; P <0.001

Lapatinib + Capecitabine

6.4 months

 
  

TH3RESA

NCT01419197

Phase III

MBC (in third line)

 

T-DM1

6.2 months

HR 0.528; 95% CI 0.422-0.661; P <0.0001

Physician’s choice treatment

3.3 months

 

Lapatinib

HER1/HER2

EGF104900

NCT00320385

Phase III

MBC trastuzumab resistant

PFS

Lapatinib + trastuzumab Lapatinib

11.1 months

HR 0.74; 95% CI 0.58-0.94; P = 0.011

8.1 months

 
  

NSABP B-41

NCT00486668

Phase III

Neo adjuvant

pCR

Paclitaxel + Trastuzumab

53.5%

 
       

Paclitaxel + Lapatinb

52.5%

 
       

Paclitaxel + Lapatinib + Trastuzumab

62.0%

 
  

NeoALTTO

NCT00553358

Phase III

Neo adjuvant

pCR

Paclitaxel + Trastuzumab

29.5%

 
       

Paclitaxel + Lapatinb

24.7%

 
       

Paclitaxel + Lapatinib + Trastuzumab

51.3%

difference 21.1%; 95% CI 9.1-34.2; P = 0.0001).

  

ALLTO

NCT00490139

Phase III

Adjuvant

DFS

Trastuzumab

86.0%

 
       

Trastuzumab + Lapatinib

88.0%

 

Sequential Trastuzumab/Lapatinib

  

Geyer and al.

NCT00078572

Phase III

Locally advanced/MBC

TTP

Capecitabine + Lapatinib Capecitabine

8.4 months

HR 0.57; 95% CI 0.44-0.77; P <0.001

4.4 month

 
  

GeparQuinto

NCT00567554

Phase III

Neo adjuvant

pCR

Chemotherapy + Trastuzumab

30.3%

OR 0 . 68; 95% CI 0.47-0.97; P = 0 . 04

       

Chemotherapy + Lapatinib

22.7%

 

Bevacizumab

VEGFA

AVEREL

 

Phase III

Locally recurrent/MBC

PFS

Docetaxel + Trastuzumab + Bevacizumab Docetaxel + Trastuzumab

16.8 months

 

13.9 months

  

BETH

NCT00625898

Phase III

Adjuvant

DFS

Chemotherapy + Trastuzumab + Bevacizumab Chemotherapy + Trastuzumab

 

HR 1.00; 95% CI 0.79-1.26

Everolimus

m TOR

BOLERO-3

NCT01007942

Phase III

Locally advanced/MBC

PFS

Trastuzumab + Vinorelbine + Everolimus Trastuzumab + Vinorelbine

30.4 weeks

HR 0.78; 95% CI 0.65-0.96; P = 0.0067

25.1 weeks

 
  1. CI, confidence interval; DFS, disease free survival; HR, hazard ratio; MBC, metastatic breast cancer; mTOR, mammalian target of rapamycin; OR, odds ratio; pCR, pathological complete response; PFS, progression free survival; TTP, time to progression; VEGFA, vascular endothelial growth factor A.