NCT03577743

Brief Summary

Evaluating efficacy and safety of bevacizumab when combined with chemotherapy (carboplatin and Paclitaxel ) in treatment of patient with metastatic triple negative breast cancer

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 24, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 5, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

1.7 years

First QC Date

June 24, 2018

Last Update Submit

March 7, 2021

Conditions

Metastatic Triple Negative Breast CancerSafety IssuesEfficacy

Keywords

antiangiogenesistaxanes and carboplatinmetastatic TNBC

Outcome Measures

Primary Outcomes (1)

  • - progression free survival

    the length of time during and after the treatment that a patient lives with the disease but it does not get worse

    after six month from last enrollment

Secondary Outcomes (2)

  • - Response rate (R.R) :

    after 1 year from enrollment

  • - Over all survival.

    after 3 years

Study Arms (1)

experimental arm

EXPERIMENTAL

bevacizumab and chemotherapy given every 21 day untill disease progression or unacceptable toxicity

Drug: Bevacizumab

Interventions

BevacizumabDRUG

-bevacizumab 15m.g/ kg + carboplatin 450m.g + paclitaxel 175m.g/m2 D1 /21 Day until disease progression or un acceptable toxicity .

Also known as: avastin
experimental arm

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patient firstly diagnosed with metastatic TNBC or after adjuvant treatment OF TNBC by immune histochemistry and biopsy
  • Age \>18 Y
  • Performance status (PS ) 0-2
  • Did not have any bleeding disorders.
  • Receive only one line of chemotherapy in adjuvant ttt

You may not qualify if:

  • Male patient
  • PS \>2
  • Uncontrolled HPTN
  • Have history of bleeding disorders
  • Receive \> one line of chemotherapy
  • Have other type of malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Oncology Departement Assuit University Hospital

Asyut, Assuit, Egypt

Location

Related Publications (4)

  • Brufsky A, Valero V, Tiangco B, Dakhil S, Brize A, Rugo HS, Rivera R, Duenne A, Bousfoul N, Yardley DA. Second-line bevacizumab-containing therapy in patients with triple-negative breast cancer: subgroup analysis of the RIBBON-2 trial. Breast Cancer Res Treat. 2012 Jun;133(3):1067-75. doi: 10.1007/s10549-012-2008-6. Epub 2012 Mar 14.

    PMID: 22415477RESULT

  • Zielinski C, Lang I, Inbar M, Kahan Z, Greil R, Beslija S, Stemmer SM, Zvirbule Z, Steger GG, Melichar B, Pienkowski T, Sirbu D, Petruzelka L, Eniu A, Nisenbaum B, Dank M, Anghel R, Messinger D, Brodowicz T; TURANDOT investigators. Bevacizumab plus paclitaxel versus bevacizumab plus capecitabine as first-line treatment for HER2-negative metastatic breast cancer (TURANDOT): primary endpoint results of a randomised, open-label, non-inferiority, phase 3 trial. Lancet Oncol. 2016 Sep;17(9):1230-9. doi: 10.1016/S1470-2045(16)30154-1. Epub 2016 Aug 5.

    PMID: 27501767RESULT

  • Robert NJ, Dieras V, Glaspy J, Brufsky AM, Bondarenko I, Lipatov ON, Perez EA, Yardley DA, Chan SY, Zhou X, Phan SC, O'Shaughnessy J. RIBBON-1: randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab for first-line treatment of human epidermal growth factor receptor 2-negative, locally recurrent or metastatic breast cancer. J Clin Oncol. 2011 Apr 1;29(10):1252-60. doi: 10.1200/JCO.2010.28.0982. Epub 2011 Mar 7.

    PMID: 21383283RESULT

  • Mohamed RF, Bakri HM, Abdelfattah ON, Eid S. Does bevacizumab carry a hope for metastatic triple-negative breast cancer in the era of immunotherapy? Anticancer Drugs. 2022 Jan 1;33(1):e604-e609. doi: 10.1097/CAD.0000000000001192.

    PMID: 34407054DERIVED

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • assuit university

    Assiut University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant lecturer

Study Record Dates

First Submitted

June 24, 2018

First Posted

July 5, 2018

Study Start

July 1, 2018

Primary Completion

March 15, 2020

Study Completion

February 15, 2021

Last Updated

March 9, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol (BMTN)Access

Locations

EG(1)