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

Sponsor
Borstkanker Onderzoek Groep
Study ID
NCT01935492
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel, Bevacizumab, liposomal doxorubicin, Capecitabine — DRUG
    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.
  • Paclitaxel, Bevacizumab, liposomal doxorubicin, Capecitabine — DRUG
    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.

Study Details

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.

Key Dates

First listed
Sep 5, 2013
Start date
Nov 30, 2010
Status verified
Jan 2020
Primary completion
Apr 1, 2019
Completion
Apr 1, 2019

Study Design

Enrollment
420 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 8 cycles of Paclitaxel & bevacizumab
    8 cycles of Paclitaxel: 90 mg/m2 IV on days 1, 8 and 15 every 28 days \& Bevacizumab: 10 mg/kg IV on days 1 and 15 every 28 days
  • Active Comparator: 2 x 4 cycles of Paclitaxel & bevacizumab
    intermittent 2x4 cycles of Paclitaxel: 90 mg/m2 IV on days 1, 8 and 15 every 28 days \& Bevacizumab: 10 mg/kg IV on days 1 and 15 every 28 days

Primary Outcome Measure

Progression free survival [ Time Frame: 1 year ]

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