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8 Continuous vs 8 Intermittent Cycles in First and Second Line in HER2/Neu Neg Metastatic Breast Cancer

NCT01935492 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2020-01-18

No results posted yet for this study

Summary

An open randomized phase III study to compare 8 continuous cycles of chemotherapy with 8 cycles of intermittent (2 times 4 cycles) chemotherapy in first line treatment, in combination with bevacizumab, and second line treatment of patients with HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer.

Conditions

Interventions

DRUG

Paclitaxel, Bevacizumab, liposomal doxorubicin, Capecitabine

1. st line: * Paclitaxel and bevacizumab: 8 cycles, unless PD or unacceptable toxicity occurs earlier. * Bevacizumab until PD or unacceptable toxicity * At PD patients will go to the 2nd treatment line. 2. nd line: * Non-pegylated liposomal doxorubicin (Myocet®) (or capecitabine): 8 cycles, unless PD or unacceptable toxicity occurs earlier. * At PD patients will go to the 3rd treatment line. If possible, it is advised to cross-over from 2nd line non-pegylated liposomal doxorubicin to 3rd line capecitabine.

DRUG

Paclitaxel, Bevacizumab, liposomal doxorubicin, Capecitabine

Arm B 1. st line * Paclitaxel and bevacizumab: 4 cycles, unless PD or unacceptable toxicity * Bevacizumab until PD or unacceptable toxicity * At PD \< 3 months after last paclitaxel start 2nd treatment line. * At PD ≥ 3 months after last paclitaxel, start another 4 cycles * Bevacizumab until the next PD or unacceptable toxicity * At the next PD start the 2nd treatment line. 2. nd line: * Myocet® or capecitabine: 4 cycles, unless PD or unacceptable toxicity * At PD \< 3 months start the 3rd treatment line. If possible, advised to cross-over from 2nd line Myocet® to 3rd line capecitabine. * At PD ≥ 3 months after last administration of Myocet® or capecitabine, start another 4 cycles of Myocet® or capecitabine * At the next PD start 3rd treatment line.

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Teva Pharma

    collaborator INDUSTRY

  • Borstkanker Onderzoek Groep

    lead NETWORK

Principal Investigators

  • F.L.G. Erdkamp, PhD · Orbis Medical Centre

  • M.M.E.M. Bos, PhD · RdGG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2019-04-01
Completion
2019-04-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01935492 on ClinicalTrials.gov