NCT01935492

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

8 Continuous vs 8 Intermittent Cycles in First and Second Line Treatment of Patients With HER2/Neu Negative, Incurable, Metastatic or Unresectable Locally Advanced Breast Cancer.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: Borstkanker Onderzoek Groep · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary goal of this non-inferiority trial is to determine if the results obtained with a intermittent chemotherapy regimen (2 x 4 cycles of paclitaxel) are not inferior to the results of a continuous chemotherapy regimen (8 cycles of paclitaxel), both combined with bevacizumab in first line treatment of patients with HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer.

Conditions

• Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
• Metastatic Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-11-01
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2013-09-05
• Last updated: 2020-01-18

Locations

1 site across 1 country: Netherlands