Neoadjuvant chemotherapy with docetaxel and anthracycline based chemotherapy in patients with advanced breast cancer: Evaluation of biological, clinical and imaging markers of tumour response.

Conditions

None listed

Brief summary

This study is evaluating the effect of neoadjuvant chemotherapy with docetaxel and anthracycline in patients with advanced breast cancer. Who is it for? You may be eligible to join this study if you are a female aged 18 years or above who has a diagnosis of locally advanced breast cancer. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will undergo 4 cycles of chemotherapy with docetaxel followed by 4 cycles of chemotherapy with anthracycline. Participants in the other group will receive the same treatments in reverse order. The overall duration of treatment in each group is 24 weeks. All participants will be monitored for up to 5 years in order to evaluate clinical response and to identify markers that correlate with tumour response to chemotherapy. Assessments required include clinical examinations, mammogram, PET scan, MRI scan, blood tests and biopsy. We believe this study may help us in individualising cancer treatment.

Muhammad Alamgeer, Vinod Ganju, Beena Kumar, Jane Fox, Stewart Hart et al. (11 authors)

Breast Cancer Research2014-04-2457 citations

10.1186/bcr3648

Papers published before 2002-11-01 may not appear yet. Historical indexing is in progress.

Interventions

Treatment A= FEC100 Epirubicin iv over 15-30 minutes 100 mg/m2 once every 21 days, 4 cyles plus Fluorouracil iv bolus 500mg/m2 once every 21 days for 4 cycles plus Cyclophosphamide iv over 60 minutes 500mg/m2 once every 21 days for 4 cycles Treatment B Docetaxel iv over 60 minutes 100 mg/m2 once every 21 days for 4 cycles Trastuzumab Iv over 15-30 min 8 mg/m2 as loading dose, subsequent dose 6mg/m2 once evewry 21 days (after completion of anthracycline) (after completion of anthracycline)

Treatment A= FEC100 Epirubicin iv over 15-30 minutes 100 mg/m2 once every 21 days, 4 cyles plus Fluorouracil iv bolus 500mg/m2 once every 21 days for 4 cycles plus Cyclophosphamide iv over 60 minutes 500mg/m2 once every 21 days for 4 cycles Treatment B Docetaxel iv over 60 minutes 100 mg/m2 once every 21 days for 4 cycles Trastuzumab Iv over 15-30 min 8 mg/m2 as loading dose, subsequent dose 6mg/m2 once evewry 21 days (after completion of anthracycline) (after completion of anthracycline) Subjects will receive treatment A followed by Treatment B with no wash out period Subjects will only recieve the Trastuzumab if they are HER2 positive

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

No

Inclusion criteria

locally advanced breast cancer

Exclusion criteria

metastatic disease (Stage 4)

Outcome results