Biweekly Avastin and Docetaxel as the First Line Treatment for Patients With Metastatic Breast Cancer (AINO)

March 27, 2019 updated by: Pirkko-Liisa Kellokumpu-Lehtinen, Tampere University Hospital

Single Arm Study of the Combination of Biweekly Avastin and Docetaxel as the First Line Treatment for Patients With Metastatic Breast Cancer

The purpose of this study is to evaluate the efficacy and safety of the combination of biweekly docetaxel and bevacizumab in the first line treatment of metastatic breast cancer by using Response Evaluation Criteria In Solid Tumors (RECIST criteria) and NCI Common Terminology Criteria for Adverse Events (NCI CTC-AE) version 3. In addition several biochemical makers are tested as possible predictive factors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients with histologically or cytologically proven measurable or nonmeasurable metastatic breast cancer are treated with a combination of biweekly docetaxel and bevacizumab as the first line treatment in multicenter phase II trial. The outcome measures would be PFS, Response rate (RECIST), duration of response, safety (NCI CTC-AE version 3) and survival. In addition several biochemical makers are tested as possible predictive factors. Treatment would be continued until PD, patient's refusal or treatment discontinuation due to side-effects or patients death. In responding patients bevacizumab would be continued either alone or in hormone receptor positive patients combined with hormone treatment until progression.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland
        • Tampere Unviersity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • written informed concent
  • age > or equal 18 years
  • able to comply with the protocol
  • histologically or cytologically confirmed, Her-2 negative, adenocarcinoma of the breast with measurable or nonmeasurable metastatic disease, chemotherapy indicated
  • ECOG 0-2, life expectancy of over or qual to 12 wks
  • prior neo/adjuvant chemotherapy allowed
  • prior adjuvant taxane therapy is allowed, DFS> or equal 6 months
  • previous hormonal therapy allowed
  • prior RT is allowed as adjuvant setting or to relief of metastatic bone pain, no more than 30% of marrow-bearing bone irradiated
  • Adequate haematological function
  • adequate liver function total bilirubin <1.5 x upper limit of normal and AST,ALT <2.5 x ULN in patients without liver metastases; <5 x ULN in patients with liver metastases
  • adequate renal function serum creatinine <or equal 1,5x ULN or calculated creatinine clearance > or equal 50mL/min and urine dipstick for proteinuria <2+. Patients discovered to have or equal proteinuria or dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate < or equal 1 g of protein in 24 hours
  • INR<or equal 1.5 and PTT< or equal 1.5 x ULN within 7 days prior to enrolment. Anticoagulation treatment not allowed
  • if female, should not be pregnant or breast-feeding. Women with an intact uterus must have a negative serum pregnancy test within 28 days prior to inclusion into the study

Exclusion Criteria:

  • previous chemotherapy for mBC
  • radiation therapy for the treatment of metastatic disease within 28 days
  • evidence of CNS metastases. If symptomatic, the patient should be scanned within 28 days to enrolment to rule out CNS metastases
  • pre-existing peripheral neuropathy NCI CTC-AE grade > 2 at enrolment
  • major surgery, significant traumatic injury within 28 days prior to enrolment or anticipation of the need for major surgery during study treatment
  • Minor surgery, including insertion off an indwelling catheter, within 24 hours prior to the first line bevacizumab infusion
  • Current or recent(within 10 daÿs of first dose of bevacizumab) use of aspirin (>325mg/day)
  • current or recent (within 10 days of first dose of bevacizumab) use of oral or parenteral anticoagulants or thrombolytic agents.
  • history of evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
  • uncontrolled hypertension (systolic >150mmHg and/or diastolic>100mmHg)
  • Clinically significant cardiovascular disease for example CVA, myocardial infarction, unstable angina, congestive heart failure NYHA Class > or equal II, serious cardiac arrhythmia requiring medication during the study, which might interfere with regularity of the study treatment, or not controlled by medication
  • non- healing wound, active peptic ulcer or bone fracture
  • history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment
  • past of current history (within the last 5 years) of other malignancies except curatively treated basal and squamous cell carcinoma of the skin or in-situ carcinoma of the cervix
  • treatment with any other investigational agent, or participation in another clinical drug trial within 28 days prior to enrolment
  • evidence of any other disease, neurological, psychiatric or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications
  • history of thrombotic disorders within last six months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: chemoterapy
docetaxel/paclitaxel + bevacizumab
Drug: Docetaxel
Other Names:
  • bevacizumab

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
progression free survival
Time Frame: 1-3 months
increase of cancer burden
1-3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
efficacy, changes in metastacic lesions
Time Frame: every 2 months
response rate
every 2 months
overall survival
Time Frame: 2- 3 months
alive
2- 3 months
time to response
Time Frame: 2 months
decrease of cancer burden
2 months
duration of response
Time Frame: 2 months
gain
2 months
progression free survival from first relapse
Time Frame: 2 months
second increase of cancer burden
2 months
safety, occurence of side-effects
Time Frame: 1 month
side effects according to NCICTC-AE version 3.0
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tampere University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Turku University Hospital
Oulu University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pirkko-Liisa I Kellokumpu-Lehtinen, MD, Tampere University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EudraCT 2008-003527-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Clinical Study Report

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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