Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments bevacizumab [avastin], docetaxel, trastuzumab [herceptin]
Phase phase 2
Sponsor Hoffmann-La Roche
Start date May 2010
End date November 2017
Trial size 152 participants
Trial identifier NCT01142778, 2009-013410-26, ML22229

Summary

This randomized, open-label study will assess the effect of adding Avastin (bevacizumab) to Herceptin (trastuzumab) plus docetaxel in neoadjuvant therapy in patients with early stage HER2-positive breast cancer. After 2 cycles of Herceptin and docetaxel once every 3 weeks, patients with a response of <70% on Positron Emission Tomography will be randomized 2:1 to receive cycles 3 to 6 of Herceptin (6mg/kg iv) and docetaxel (100mg/m2 iv) with or without Avastin (15mg/kg iv). Patients with a response of >/=70% will receive Herceptin plus docetaxel for cycles 3 to 6. After surgery, all patients will receive a further 12 cycles of Herceptin plus standard of care treatment and will be followed for up to 5 years. Anticipated time on study treatment is 18 weeks.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
bevacizumab [avastin]
15mg/kg iv, cycles 3-6
docetaxel
100mg/m2 iv, cycles 1-6
trastuzumab [herceptin]
8mg/kg iv cycle 1, 6mg/kg iv cycles 2-6; plus an additional 12 cycles post surgery
(Active Comparator)
docetaxel
100mg/m2 iv, cycles 1-6
trastuzumab [herceptin]
8mg/kg iv cycle 1, 6mg/kg iv cycles 2-6; plus an additional 12 cycles post surgery

Primary Outcomes

Measure
Pathological complete response (according to Chevalier criteria, reviewed by independent committee)
time frame: after 6 cycles (18 weeks) of neoadjuvant therapy

Secondary Outcomes

Measure
Ultrasound response rate (according to RECIST criteria)
time frame: after 6 cycles (18 weeks) of neoadjuvant treatment
Rate of conservative surgery
time frame: after 6 cycles (18 weeks) of neoadjuvant treatment
Relapse/disease-free survival
time frame: from baseline to occurrence of relapse/disease or death of any cause (up to 5 years)
Overall survival
time frame: from baseline to death of any cause (up to 5 years)
Safety: Adverse events
time frame: throughout study (up to 5 years)

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - female patients, >/=18 years of age - early stage HER2-positive breast cancer - scheduled to receive neoadjuvant therapy with the objective of conservative surgery - ECOG performance status 0, 1 or 2 Exclusion Criteria: - partially or totally lobular carcinoma - inflammatory breast cancer - bifocal and/or bilateral tumour - metastases - previous treatment with chemotherapy, radiation therapy or hormone therapy for breast cancer - previous history of cancer (other than curatively treated basal and squamous cell carcinoma of the skin and/or in situ carcinoma of the cervix) relapsing within the 5 years before study entry or in situ contralateral breast carcinoma

Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.