NCT01303679

Brief Summary

In first-line metastatic breast cancer, the bevacizumab-taxane to progression or toxicity, is currently the standard treatment. In patients expressing hormone receptors, it was shown that hormone therapy administered in maintenance after induction chemotherapy, could have a benefit regarding the progression-free survival. The investigators make the hypothesis that there would be interest to discontinue treatment with taxane after 4 months, and to begin hormone therapy while continuing maintenance bevacizumab. Exemestane was chosen because it has been shown potentially active in patients who progressed after letrozole, anastrozole or tamoxifen.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
117

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2010

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

June 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

4 years

First QC Date

February 23, 2011

Last Update Submit

September 5, 2023

Conditions

First Line Metastatic Breast Cancer

Keywords

First line metastatic breast cancerPositive estrogen receptorsNegative HER2 receptorsAt least stable disease after 4 months of paclitaxel-bevcizumab induction chemotheray

Outcome Measures

Primary Outcomes (1)

  • Primary free survival

    24 months for recruitment and 18 months for follow up

Study Arms (2)

paclitaxel-bevacizumab

ACTIVE COMPARATOR

Paclitaxel, 80mg/m² at d1, d8, d15 bevacizumab, 10 mg/kg at d1, d15

Drug: PaclitaxelDrug: Bevacizumab

exemestane-bevacizumab

EXPERIMENTAL

exemestane, 25 mg daily dose bevacizumab, 15mg/kg every 3 weeks

Drug: BevacizumabDrug: Exemestane

Interventions

PaclitaxelDRUG

IV, 80mg/m² at d1, d8, d15

paclitaxel-bevacizumab
BevacizumabDRUG

IV, 10 mg/kg at d1, d15 or IV, 15 mg/kg every 3 weeks

exemestane-bevacizumabpaclitaxel-bevacizumab
ExemestaneDRUG

daily 25 mg (1 pill) oral intake

exemestane-bevacizumab

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 ans.
  • Metastatic breast cancer or locally advanced
  • RE+, HER2-
  • Patient receiving paclitaxel-bevacizumab first line chemotherapy

You may not qualify if:

  • Previous treatment by exemestane (both in adjuvant or metastatic treatment).
  • st line of chemotherapy different thaan paclitaxel-bevacizumab.
  • Treatment by paclitaxel-bevacizumab \> 18 weeks.
  • HER2 positifs et/ou récepteurs aux oestrogènes négatifs.
  • Previous significant surgery within the 28 days before treatment start
  • Previuous coagulopathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BACHELOT

Lyon, 69000, France

Location

Related Publications (1)

  • Tredan O, Follana P, Moullet I, Cropet C, Trager-Maury S, Dauba J, Lavau-Denes S, Dieras V, Beal-Ardisson D, Gouttebel M, Orfeuvre H, Stefani L, Jouannaud C, Burki F, Petit T, Guardiola E, Becuwe C, Blot E, Pujade-Lauraine E, Bachelot T. A phase III trial of exemestane plus bevacizumab maintenance therapy in patients with metastatic breast cancer after first-line taxane and bevacizumab: a GINECO group study. Ann Oncol. 2016 Jun;27(6):1020-1029. doi: 10.1093/annonc/mdw077. Epub 2016 Feb 24.

    PMID: 26916095DERIVED

MeSH Terms

Interventions

PaclitaxelBevacizumabexemestane

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Thomas BACHELOT, Md

    GINECO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2011

First Posted

February 25, 2011

Study Start

June 1, 2010

Primary Completion

June 1, 2014

Study Completion

May 1, 2018

Last Updated

September 6, 2023

Record last verified: 2023-09

Locations

FR(1)