WO40324 - FDC of pertuzumab + trastuzumab + chemo in Her 2+ EBC
Research type
Research Study
Full title
A PHASE III, RANDOMIZED, MULTICENTER, OPEN-LABEL, TWO-ARM STUDY TO EVALUATE THE PHARMACOKINETICS, EFFICACY, AND SAFETY OF SUBCUTANEOUS ADMINISTRATION OF THE FIXED-DOSE COMBINATION OF PERTUZUMAB AND TRASTUZUMAB & CHEMOTHERAPY IN PATIENTS WITH HER2 POSITIVE EARLY BREAST CANCER
IRAS ID
242937
Contact name
Mark Verrill
Contact email
Sponsor organisation
Roche Products Limited
Eudract number
2017-004897-32
Duration of Study in the UK
6 years, 8 months, 2 days
Research summary
The purpose of this study is to compare the effects, good or bad, of a fixed dose combination of trastuzumab and pertuzumab when administered subcutaneously (under the skin) with the effects of Perjeta and Herceptin when both are administered intravenously (into a vein) in patients with HER2-positive early breast cancer.
Tumors that have high levels of the HER2 protein (this is a receptor called “human epidermal growth factor receptor 2” (usually just called “HER2-positive breast cancer”) have been shown to respond to Perjeta® (pertuzumab) and Herceptin® (trastuzumab), because these drugs act by targeting this receptor.
Both Perjeta® and Herceptin® are approved for treatment of patients with HER2-positive early and advanced breast cancer.Roche has developed a new product combining pertuzumab and trastuzumab in one fixed-dose combination for subcutaneous injection (injection into fatty tissue just under your skin) that will be compared to Herceptin and perjeta administered intravenously (into a vein).
Patients will be randomly allocated into 1 of 2 groups after some initial tests to ensure they are suitable to participate.
Patients will receive 8 cycles of chemotherapy including 4 cycles of either the fixed dose combination or Herceptin and perjeta in to a vein as prescribed by the clinician, then may undergo breast-conserving surgery or mastectomy in accordance with routine clinical practice. Thereafter, patients will receive an additional 14 cycles of either the fixed dose combination or Herceptin and perjeta in to a vein for a total of 18 cycles.
Arm A- Perjeta + Herceptin will be given into a vein
Arm B - Pertuzumab + trastuzumab will be given under the skin (subcutaneously) as the fixed dose combination
All patients will receive approximately 12 months of treatment and will then be followed until approximately 3 years after the last patient’s last treatment, even if their assigned treatment is discontinued early. For this reason, some patients will be followed for more than 5 years (because of the 12-month projected recruitment period).
There will be approximately 500 patients globally with 44 patients recruited at 8 UK sites
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
18/NE/0132
Date of REC Opinion
29 May 2018
REC opinion
Further Information Favourable Opinion