Persephone : Duration of Trastuzumab with Chemotherapy in patients with early breast cancer : Six months versus twelve

• Conditions: HER2 positive early breast cancer

• Registration Number: EUCTR2006-007018-39-GB
• Lead Sponsor: Cambridge Hospitals NHS Foundation Trust and Cambridge University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-15
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Histological diagnosis of invasive breast cancer.
•No evidence of metastatic disease.
•Known hormone receptor status.
•Overexpression of HER2 receptor.
•Clear indication for neo-adjuvant or adjuvant chemotherapy based on clinical and histopathological features.
•Patient fit to receive neo-adjuvant or adjuvant chemotherapy and trastuzumab in the opinion of the responsible physician.
•No previous diagnosis of malignancy unless:
-managed by surgical treatment only, and disease-free for 10 years.
-previous basal cell carcinoma, cervical carcinoma in situ or ductal carcinoma in situ of the breast.
•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.
•No concomitant medical or psychiatric problems that might prevent completion of treatment or follow-up.
•Women or men 18 years or older.
•Written informed consent for the study given at any time before the 10th cycle of trastuzumab.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Clinically significant cardiac disease including or significant co-morbidity in the opinion of the responsible physician adding to the risks associated with trastuzumab or cytotoxic chemotherapy.
•Inability to comply with protocol requirements.
•Patient having received more than 9 cycles of trastuzumab.
•Any other condition, which in the local investigator’s opinion would make the patient unsuitable for participating in the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified