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

NCT00979641 | Terminated Phase 2 DMC

• 1 other identifier: EudraCT 2008-003527-24
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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) version 3. In addition several biochemical makers are tested as possible predictive factors.

Conditions

Neoplasms

Keywords

breast cancer; metastatic; chemotherapy; bevacizumab; docetaxel; Phase II; first line chemotherapy; metastatic breast cancer patients

Outcome Measures

Primary Outcomes (1)

• progression free survival

  increase of cancer burden

  1-3 months

Secondary Outcomes (6)

• efficacy, changes in metastacic lesions

  every 2 months

• overall survival

  2- 3 months

• time to response

  2 months

• duration of response

  2 months

• progression free survival from first relapse

  2 months

Study Arms (1)

chemoterapy

EXPERIMENTAL

docetaxel/paclitaxel + bevacizumab

Drug: Docetaxel

Interventions

Docetaxel DRUG

Also known as: bevacizumab

chemoterapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tampere University Hospital: lead
• Oulu University Hospital: collaborator
• Turku University Hospital: collaborator

Study Sites (1)

Tampere Unviersity Hospital

Tampere, Finland

Location

Related Publications (3)

• 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.

  PMID: 38468231 DERIVED

• 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.

  PMID: 31340773 DERIVED

• 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.

  PMID: 27919965 DERIVED

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Neoplasm Metastasis

Interventions

Docetaxel; Bevacizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Pirkko-Liisa I Kellokumpu-Lehtinen, MD

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

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: professor of oncology and radiotherapy

Study Record Dates

• First Submitted: December 19, 2008
• First Posted: September 18, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 28, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)