BP22572, trastuzumab-MCC-DM1 (T-DM1) study in HER2+ mBC patients

• Research type

  Research Study

• Full title

  An open-label, multi-center study of the safety and tolerability of the combination of Trastuzumab-MCC-DM1 (T-DM1) with docetaxel, and potentially pertuzumab, for treatment for patients with advanced breast cancer.

• IRAS ID

  20655

• Contact name

  John Dewar

• Eudract number

  2009-010000-28

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The primary objective of this study is to determine the safety and tolerability of T-DM1 (trastuzumab-MCC-DM1), a new chemotherapy based agent linked to trastuzumab dosed in combination with docetaxel (a taxane). This combination will be administered in patients who have metastatic breast cancer that is HER2/neu positive. Treatment with a taxane and trastuzamab is a recommended treatment option. Patients will receive docetaxel plus T-DM1 for a minimum of 6 3-weekly cycles, followed by T-DM1 alone, unless modified by toxicity with either drug. In this case patients will then remain on a single regimen of T-DM1 until disease progression. There are two parts to the study. Part 1: Patients will receive 75mg/m2 of docetaxel with 2.4mg/kg of T-DM1. If it is safe and patients tolerate these doses well then another group of patients will receive docetaxel at 75mg/m2 with 3.6mg/kg T-DM1. Between 6 and 18 patients will be recruited for Part 1. Part 2A: Using the dose determined to be safe and tolerable from Part 1, patients will be administered the selected doses every 3 weeks until disease progression. Part 2B: A group of first line patients (those having not received any previous treatment for metastatic breast cancer) will be recruited to receive docetaxel at 100mg/m2 and T-DM1 at 3.6mg/kg from the second cycle onwards. Part 2 involves approximately 20 patients. Safety assessments will be performed on a regular basis in both parts of the study and includes haematology, biochemistry, cardiac assessments and adverse event assessment.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  09/H0606/69

• Date of REC Opinion

  24 Aug 2009

• REC opinion

  Further Information Favourable Opinion