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NeoplasmsPhase 2AINONCT00979641

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

A Phase 2 study testing Docetaxel in people with Neoplasms, run by Tampere University Hospital at 1 site in Finland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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)… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Neoplasms
What is being tested?
Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteFinland
Study dates
Jan 2009to Dec 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • Tampere Unviersity Hospital

    Tampere

Other trials in Finland

About this study

Official title: 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.

Read the 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.

Conditions
Neoplasms
Being tested
Docetaxel
Keywords
breast cancer, metastatic, chemotherapy, bevacizumab, docetaxel, Phase II, first line chemotherapy, metastatic breast cancer patients
Medical subject headings
Neoplasms, Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00979641
Study groupRoleWhat they receive
chemoterapyExperimentaldocetaxel/paclitaxel + bevacizumab
Receives: Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression free survival

    increase of cancer burden

    Measured: 1-3 months

Secondary outcomes (6)

  1. efficacy, changes in metastacic lesions

    response rate

    Measured: every 2 months

  2. overall survival

    alive

    Measured: 2- 3 months

  3. time to response

    decrease of cancer burden

    Measured: 2 months

  4. duration of response

    gain

    Measured: 2 months

  5. progression free survival from first relapse

    second increase of cancer burden

    Measured: 2 months

  6. safety, occurence of side-effects

    side effects according to NCICTC-AE version 3.0

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2009 (estimated)
  2. Study startJan 2009
  3. Primary completionDec 2014
  4. Study completionDec 2014

Why it stopped: Participants are no longer being examined. The results are published 2016 Anticancer Research 36: 6431-6438

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00979641
Sponsor's protocol ID
EudraCT 2008-003527-24
Acronym
AINO
Status last verified
Mar 2019
First submitted
19 Dec 2008
Last updated
28 Mar 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Maenpaa N, Tiainen L, Hamalainen M, Luukkaala T, Tanner M, Lahdenpera O, Vihinen P, Karihtala P, Kellokumpu-Lehtinen PL, Moilanen E, Jukkola A. Neuropilin-1 and placental growth factor as prognostic factors in metastatic breast cancer. BMC Cancer. 2024 Mar 11;24(1):331. doi: 10.1186/s12885-024-12070-7.

    PubMed 38468231

  • Tiainen L, Korhonen EA, Leppanen VM, Luukkaala T, Hamalainen M, Tanner M, Lahdenpera O, Vihinen P, Jukkola A, Karihtala P, Aho S, Moilanen E, Alitalo K, Kellokumpu-Lehtinen PL. High baseline Tie1 level predicts poor survival in metastatic breast cancer. BMC Cancer. 2019 Jul 24;19(1):732. doi: 10.1186/s12885-019-5959-8.

    PubMed 31340773

  • Tiainen L, Tanner M, Lahdenpera O, Vihinen P, Jukkola A, Karihtala P, Paunu N, Huttunen T, Kellokumpu-Lehtinen PL. Bevacizumab Combined with Docetaxel or Paclitaxel as First-line Treatment of HER2-negative Metastatic Breast Cancer. Anticancer Res. 2016 Dec;36(12):6431-6438. doi: 10.21873/anticanres.11241.

    PubMed 27919965

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel in people with Neoplasms, run by Tampere University Hospital at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Participants are no longer being examined. The results are published 2016 Anticancer Research 36: 6431-6438). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression free survival (time frame: 1-3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00979641, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2019.

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