8 Continuous vs 8 Intermittent Cycles in First and Second Line in HER2/Neu Neg Metastatic Breast Cancer
Stop&Go
2 other identifiers
interventional
420
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2010
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 26, 2010
CompletedFirst Posted
Study publicly available on registry
September 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedJanuary 18, 2020
January 1, 2020
8.4 years
November 26, 2010
January 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival
PFS is defined as the time from start of treatment to the documented progression that requires the patient to switch to the next treatment line or to death due to any cause.
1 year
Secondary Outcomes (7)
Progression free survival second line treatment
1 year
Objective overall response rate
1 year
Duration of objective response
1 year
Overall survival
1 year
Safety and tolerability. The total number of grade 3 and 4 adverse events will be analyzed.
1 year
- +2 more secondary outcomes
Study Arms (2)
8 cycles of Paclitaxel & bevacizumab
ACTIVE COMPARATOR8 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
2 x 4 cycles of Paclitaxel & bevacizumab
ACTIVE COMPARATORintermittent 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- Female patients ≥ 18 years old.
- Patients with HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer, who are candidates for chemotherapy.
- Patients with measurable or evaluable-only (RECIST 1.1)
- Documented Estrogen Receptor (ER) / Progesteron Receptor (PR) status.
- HER2/neu-negative disease
- Patients with an ECOG Performance Status ≤ 2.
- Life expectancy of \> 12 weeks.
- Signature of Informed Consent Form
You may not qualify if:
- Previous chemotherapy for HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer.
- Prior hormonal therapy for HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer that has not been discontinued 1 week before start of study treatment.
- Prior adjuvant/neo-adjuvant chemotherapy within 6 months prior to first study treatment. However, if the prior adjuvant/neo-adjuvant chemotherapy was taxane based, patients are excluded if they received their last chemotherapy within12 months prior to first study treatment.
- Prior radiotherapy covering more than 30% of marrow-bearing bone.
- Patients that have received recent radiation therapy that are not recovered from any significant (Grade ≥ 3) acute toxicity prior to study treatment.
- Prior therapy with bevacizumab, sorafenib, sunitinib, or other VEGF pathway-targeted therapy.
- Chronic daily treatment with aspirin
- Chronic daily treatment with corticosteroids, with the exception of inhaled steroids.
- Current or recent treatment with another investigational drug or participation in another investigational study.
- Inadequate bone marrow, liver, renal function
- INR \> 1.5 or an aPTT \> 1.5 x ULN within 7 days prior to first study treatment.
- Known CNS disease, except for treated brain metastases.
- Patients with concurrent active malignancy
- Pregnant or lactating
- Women of childbearing potential not using effective, non-hormonal means of contraception
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Borstkanker Onderzoek Groeplead
- Roche Pharma AGcollaborator
- Teva Pharmacollaborator
Study Sites (1)
BOOG Study Center
Amsterdam, 1006 AE, Netherlands
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
F.L.G. Erdkamp, PhD
Orbis Medical Centre
- PRINCIPAL INVESTIGATOR
M.M.E.M. Bos, PhD
RdGG
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2010
First Posted
September 5, 2013
Study Start
November 1, 2010
Primary Completion
April 1, 2019
Study Completion
April 1, 2019
Last Updated
January 18, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share