Wildiers, et al. [10]

Zhang, et al. [9]

Type of study

RCT

RCT

Setting

Open-label, phase 2, single-centre

Open-label, phase 2, multi-centered across 30 centers in Europe

Number of participants

n = 80 (41 intervention, 39 comparator)

n = 66 (35 intervention, 31 comparator)

Patient characteristics

Median age:

Intervention- 77.3 years

Comparator- 76.2 years

Age (Mean ± SD):

Intervention: 52.3 ± 5.6 years

Comparator: 53.6 ± 4.3 years

Intervention

Metronomic oral cyclophosphamide 50 mg per day plus trastuzumab and pertuzumab,

Metronomic oral cyclophosphamide 50 mg per day plus docetaxel 75mg/m2, d1 plus

Comparator

Transtuzumab and pertuzumab

Docetaxel alone

Outcome of interest for this review

Overall response rate (complete response + partial response)

Overall response rate (complete response + partial response)

Method used for outcome measurement

RECIST version 1.1

RECIST version 1.1

 Median follow up

 20.7 months

 40 months

 Results

 Source of funding

 Study drugs and financial support provided by F Hoffmann-La Roche

 Supported by Shanghai Municipal Science and Technology Commission Guidance Project, P.R. China

Clinical trial registration number

NCT01597414

NCT01526499