NCT01142778|CompletedPhase 2

A Study of Bevacizumab Added to Trastuzumab Plus Docetaxel in the Neoadjuvant Setting in Participants With Early Stage HER2-Positive Breast Cancer

AVATAXHER

An Open-Label, Randomized, Multicenter, Phase II, Non Comparative, Exploratory Study on Neoadjuvant Treatment With Trastuzumab Plus Docetaxel Plus Bevacizumab According to Positon Emission Tomography (PET) Value Modification in Patients With Early Stage HER2 Positive Breast Cancer

Hoffmann-La Roche ClinicalTrials.gov

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2 other identifiers

ML222292009-013410-26

Study Type

interventional

Target

152

Locations

1 country

Sites

Timeline

RegisteredJun 2010

StartedMay 2010

CompletionDec 2017

Brief Summary

This randomized study will assess the effect of adding bevacizumab to trastuzumab plus docetaxel in neoadjuvant therapy in participants with early stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer. After 2 cycles of trastuzumab and docetaxel once every 3 weeks, participants with a response (change in standard uptake value \[SUV\]) of less than (\<) 70 percent (%) on Positron Emission Tomography (PET) will be randomized in a 2:1 ratio to receive Cycles 3 to 6 of trastuzumab (6 milligrams per kilogram \[mg/kg\]) and docetaxel (100 milligrams per square meter \[mg/m\^2\]) with or without bevacizumab (15 mg/kg). Participants with a response of greater than or equal to (\>/=) 70% will receive trastuzumab plus docetaxel in Cycles 3 to 6. All participants will receive trastuzumab alone in Cycle 7, and will undergo surgery (as per investigator's discretion) after Cycle 7 and between 4 and 6 weeks after the treatment perfusion of Cycle 6. After surgery, all participants will receive a further 11 cycles of trastuzumab plus radiotherapy (starting from 4-8 weeks after surgery during 4-6 weeks, according to site's standard practice) with or without hormonal therapy (mandatory if positive hormone receptors). Participants will be followed for up to 5 years from start of neoadjuvant treatment.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

152

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline

Completed

Started May 2010

Longer than P75 for phase_2 breast-cancer

Geographic Reach

1 country

28 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.6 years study duration

Study Start

First participant enrolled

May 19, 2010

Completed

22 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2010

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2010

Completed

7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2017

Completed

Last Updated

March 16, 2018

Status Verified

March 1, 2018

Enrollment Period

7.6 years

First QC Date

June 10, 2010

Last Update Submit

March 15, 2018

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With Pathological Complete Response as per Chevallier's Classification as Reviewed by an Independent Committee
After 6 cycles (18 weeks) of neoadjuvant therapy (cycle length=21 days)

Secondary Outcomes (9)

Percentage of Participants With Pathological Complete Response According to Chevallier's Classification as per Local Procedures
After 6 cycles (18 weeks) of neoadjuvant therapy (cycle length=21 days)
Percentage of Participants With Pathological Complete Response According to Sataloff's Classification as Reviewed by an Independent Committee
After 6 cycles (18 weeks) of neoadjuvant therapy (cycle length=21 days)
Percentage of Participants With Ultrasound Response According to Modified Response Evaluation Criteria in Solid Tumors (RECIST)
Neodajuvant treatment period (21 weeks)
Percentage of Participants With Conservative Surgery Post Neoadjuvant Treatment
Week 20 (between Day 28 and Day 35 after the Cycle 6, cycle length=21 days)
Local Relapse-Free Interval (LRFI) According to Modified RECIST Criteria
From baseline to occurrence of relapse/disease or death of any cause (up to 5 years)
+4 more secondary outcomes

Study Arms (3)

Trastuzumab, Docetaxel, and Bevacizumab

EXPERIMENTAL

Participants will receive 2 cycles of trastuzumab and docetaxel once every 3 weeks. Then, participants with a response of \<70% will receive trastuzumab and docetaxel along with bevacizumab in Cycles 3 to 6. All participants will receive trastuzumab alone in Cycle 7, and will undergo surgery after Cycle 7 and between 4 and 6 weeks after the bevacizumab infusion in Cycle 6. After surgery, all participants will receive a further 11 cycles of trastuzumab plus radiotherapy with or without hormonal therapy as per site's standard practice, and will be followed for up to 5 years from start of neoadjuvant treatment.

Drug: BevacizumabDrug: DocetaxelDrug: TrastuzumabProcedure: SurgeryRadiation: RadiotherapyDrug: Hormonal Therapy

Trastuzumab and Docetaxel

ACTIVE COMPARATOR

Participants will receive 2 cycles of trastuzumab and docetaxel once every 3 weeks. Then, participants with a response of \<70% will receive trastuzumab and docetaxel in Cycles 3 to 6. All participants will receive trastuzumab alone in Cycle 7, and will undergo surgery after Cycle 7 and between 4 and 6 weeks after the study treatment perfusion in Cycle 6. After surgery, all participants will receive a further 11 cycles of trastuzumab plus radiotherapy with or without hormonal therapy as per site's standard practice, and will be followed for up to 5 years from start of neoadjuvant treatment.

Drug: DocetaxelDrug: TrastuzumabProcedure: SurgeryRadiation: RadiotherapyDrug: Hormonal Therapy

Trastuzumab and Docetaxel (Standard Regimen)

ACTIVE COMPARATOR

Participants will receive 2 cycles of trastuzumab and docetaxel once every 3 weeks. Then, participants with a response of \>/=70% will receive trastuzumab and docetaxel in Cycles 3 to 6. All participants will receive trastuzumab alone in Cycle 7, and will undergo surgery after Cycle 7 and between 4 and 6 weeks after the study treatment perfusion in Cycle 6. After surgery, all participants will receive a further 11 cycles of trastuzumab plus radiotherapy with or without hormonal therapy as per site's standard practice, and will be followed for up to 5 years from start of neoadjuvant treatment.

Drug: DocetaxelDrug: TrastuzumabProcedure: SurgeryRadiation: RadiotherapyDrug: Hormonal Therapy

Interventions

BevacizumabDRUG

Bevacizumab at a dose of 15 mg/kg will be administered as IV infusion over 90 minutes from Cycles 3-6 (1 Cycle=21 days).

Also known as: Avastin

Trastuzumab, Docetaxel, and Bevacizumab

DocetaxelDRUG

Docetaxel at a dose of 100 mg/m\^2 will be administered as IV infusion from Cycles 1-6 (1 Cycle=21 days).

Also known as: Taxotere