An interventional study of Trastuzumab and Weekly Paclitaxel in Breast Cancer and HER-2 Positive Breast Cancer, sponsored by Instituto do Cancer do Estado de São Paulo. Withdrawn at 1 site in Brazil. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2016-08-31.
Sponsored by Instituto do Cancer do Estado de São Paulo · Not applicable, Interventional, and Treatment
There is major concern regarding chemotherapy related toxicity in the group of women older than 65 years old diagnosed with human epidermal growth factor receptor 2 (HER2) positive breast cancer (BC). Nevertheless, these patients are at a particularly high risk of breast cancer recurrence and death. Of note, older patients may experience higher risk for Trastuzumabe related cardiotoxicity, especially when this agent is combined with an anthracycline.
Recent studies have shown extremely favourable outcomes in early HER2+ BC patients treated with a combination of paclitaxel and trastuzumab, omitting anthracyclines from treatment.
Investigators sought to investigate safety and outcome data on a cohort of elderly patients treated with weekly paclitaxel combined with carboplatin and trastuzumab.
Breast cancer is the most common female cancer and the second most common cause of cancer death in women. BC incidence is markedly increased with aging.
Amplification or overexpression of HER2 oncogene is present in approximately 18 to 20% of primary invasive BC. In the absence of HER2 target therapy combined with adjuvant or neoadjuvant chemotherapy, HER2 overexpression or amplification is associated with high rates of disease recurrence and death.
There is major concern regarding chemotherapy related toxicity in the group of women older than 65 years old diagnosed with HER2 positive breast cancer. Nevertheless, these patients are at a particularly high risk of breast cancer recurrence and death. Of note, older patients may experience higher risk for Trastuzumabe related cardiotoxicity, especially when this agent is combined with an anthracycline.
Recent studies have shown extremely favourable outcomes in early HER2+ BC patients treated with a combination of paclitaxel and trastuzumab, omitting anthracyclines from treatment.
Investigators sought to investigate safety and outcome data on a cohort of elderly patients treated with weekly paclitaxel combined with carboplatin and trastuzumab.
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Treatment schedule Weekly paclitaxel and Carboplatin at 80mg/m2 and Area under the curve (AUC) of 2, respectively. Weekly trastuzumab will be combined with chemotherapy (at a loading dose of 4mg/kg and a maintenance dose of 2mg/kg). Chemotherapy will be given at D1, D8 and D15 in a 28-day cycle, for a total of 4 treatment cycles. After completion of four chemotherapy cycles, Trastuzumab will be given at a dose of 6mg/kg every 21 days, for a total 14 cycles.
Drug: Trastuzumab · Drug: Weekly Paclitaxel · Drug: Carboplatin
Trastuzumab (at a loading dose of 4mg/kg and a maintenance dose of 2mg/kg) will be given concomitantly with chemotherapy. After completion of four chemotherapy cycles, Trastuzumab will be given at a dose of 6mg/kg every 21 days, for a total 14 cycles.
Also known as: Other names, Herceptin
Weekly paclitaxel at 80mg/m2 at D1, D8 and D15 in a 28-day cycle, for a total of 4 treatment cycles.
Also known as: Taxol
Carboplatin at an Area Under the Curve (AUC) of 2 at D1, D8 and D15 in a 28-day cycle, for a total of 4 treatment cycles.
Also known as: Other names, Paraplatin
Disease Free Survival (DFS)
Disease Free Survival was defined as the time from randomization until first relapse (local, regional, or distant), contralateral breast cancer, or death from any cause.
Time frame: 3 years
survival (OS)
Secondary end points are overall survival (OS), defined from the time from randomization until death from any cause, and safety.
Time frame: 2 years
Plan to share: No — no data avalilable
No publications or documents are linked to this record.
This study is withdrawn, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Instituto do Cancer do Estado de São Paulo