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Effect of Bevacizumab in Metastatic Triple Negative Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03577743
Recruitment Status : Recruiting
First Posted : July 5, 2018
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Hebat-Allah Mahmoud Bakri Ahmed, Assiut University

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

Condition or disease Intervention/treatment Phase
Metastatic Triple Negative Breast Cancer Safety Issues Efficacy Drug: Bevacizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study to Evaluate the Effect of Bevacizumab in Metastatic Triple Negative Breast Cancer
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: experimental arm
bevacizumab and chemotherapy given every 21 day untill disease progression or unacceptable toxicity
Drug: Bevacizumab
-bevacizumab 15m.g/ kg + carboplatin 450m.g + paclitaxel 175m.g/m2 D1 /21 Day until disease progression or un acceptable toxicity .
Other Name: avastin




Primary Outcome Measures :
  1. - progression free survival [ Time Frame: after six month from last enrollment ]
    the length of time during and after the treatment that a patient lives with the disease but it does not get worse


Secondary Outcome Measures :
  1. - Response rate (R.R) : [ Time Frame: after 1 year from enrollment ]
    length of time from the date of diagnosis to the time of death or lost follow up.

  2. - Over all survival. [ Time Frame: after 3 years ]
    the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Male patient
  2. PS >2
  3. Uncontrolled HPTN
  4. Have history of bleeding disorders
  5. Receive > one line of chemotherapy
  6. Have other type of malignancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03577743


Contacts
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Contact: Hebat-Allah M BAKRI, myself 01007272760 hebam.bakri@gmail.com
Contact: SAMIR S EID, professor 01222302375 samir_eid@hotmail.com

Locations
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Egypt
Clinical Oncology Departement Assuit University Hospital Recruiting
Assiut, Assuit, Egypt
Contact: Ola N abd elfatah, assistant professorr    01023080090    olanabih1988@gmail.com   
Contact: rehab F mohammed, assisstant professor    01004435644    faroukrehab@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
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Study Director: assuit university Assiut University
Publications of Results:
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Responsible Party: Hebat-Allah Mahmoud Bakri Ahmed, assisstant lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03577743    
Other Study ID Numbers: BMTN
First Posted: July 5, 2018    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hebat-Allah Mahmoud Bakri Ahmed, Assiut University:
antiangiogenesis
taxanes and carboplatin
metastatic TNBC
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors