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PERSEPHONE
Trastuzumab in Treating Women With HER2-Positive Early Breast Cancer
Research summary
The incidence of breast cancer continues to rise in Western Europe and the US with breast cancer remaining a major health problem despite considerable improvements in treatment of the disease both in the adjuvant and in the metastatic setting. Trastuzumab (Herceptin®) treatment in patients with early stage HER2 positive breast cancer, has proved a major advance and has demonstrated the enormous value of HER2-targeted therapy in the adjuvant setting for HER2 positive breast cancer in particular. However, the use of 12 months trastuzumab in the majority of studies is not based on evidence.
It is reasonable to consider that since the beneficial effect of adjuvant trastuzumab is detected early in follow-up (median 1 year), that the majority of the adjuvant benefit results from the first 6 months of therapy. This hypothesis is supported by evidence from the FinHer study which, with only 9 weeks trastuzumab demonstrates a similar-sized benefit to 12 months treatment, when given concurrently with chemotherapy. The recent publication of the HERA results after 8 years follow-up, demonstrates that 24 months trastuzumab is not superior to 12 months. This result was predicted by our group in the development of the PERSEPHONE trial. PERSEPHONE will compare 6 months (9 cycles) treatment with 12 months (18 cycles), in terms of safety and efficacy.
PERSEPHONE is a phase III, prospective, randomised trial of trastuzumab duration (6 months versus 12 months) in the adjuvant and neo-adjuvant setting for patients with early stage HER2 positive breast cancer. Detailed data on resource use and quality of life will be collected in an early cohort of PERSEPHONE patients (300-500 patients) for Health Economic Analysis. Quality of life data will be collected on all patients (EuroQoL). Assessment of cardiac function will be made with reference to methods used for assessment and age and other co-morbidities as risk factors. Cardiac function will be routinely assessed by LVEF measurements for all trial patients beginning with the one taken prior to the first trastuzumab dose and then throughout trastuzumab treatment done according to standard practice (minimum of 4 monthly).
Main inclusion criteria
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Histological diagnosis of invasive breast cancer
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No evidence of metastatic disease
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Known hormone receptor status
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Overexpression of HER2 receptor
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Bilateral breast cancers are eligible provided that one of the tumours is overexpressing the HER2 receptor.
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Clear indication for neo-adjuvant or adjuvant chemotherapy based on clinical and histopathological features.
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Patient fit to receive neo-adjuvant or adjuvant chemotherapy and trastuzumab in the opinion of the responsible physician.
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No previous diagnosis of malignancy unless:
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managed by surgical treatment only, and disease-free for 10 years.
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previous basal cell carcinoma, cervical carcinoma in situ or ductal carcinoma in situ of the breast.
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Non-pregnant and non-lactating, with no intention of pregnancy during chemotherapy, and agrees to adopt adequate contraceptive measures if pre-menopausal and sexually active.
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No concomitant medical or psychiatric problems that might prevent completion of treatment or follow-up.
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Patients 18 years or older.
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Written informed consent for the study given at any time before the 10th cycle of trastuzumab.
Main exclusion criteria
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No significant concomitant cardiac disease or significant concomitant co-morbidity in the opinion of the responsible physician adding to the risks associated with trastuzumab or cytotoxic chemotherapy.
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Inability to comply with protocol requirements.
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Patient having received more than 9 cycles of trastuzumab.
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Any other condition, which in the local investigator’s opinion would make the patient unsuitable for participating in the trial.
