Clinical Trials /

Randomized Phase II Study of Preoperative Letrozole (Femara) in Combination With Avastin in Hormone Receptor Positive Breast Cancer

NCT00461773

Description:

The purpose of this study is to evaluate the objective response rate of a combination of letrozole (Femara) and bevacizumab (Avastin) given preoperatively to postmenopausal patients with hormone sensitive breast cancer.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Randomized Phase II Study of Preoperative Letrozole (Femara) in Combination With Avastin in Hormone Receptor Positive Breast Cancer
  • Official Title: Randomized Phase II Study of Preoperative Letrozole (Femara) in Combination With Avastin in Hormone Receptor Positive Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: 0609001793
  • NCT ID: NCT00461773

Conditions

  • Hormone-Sensitive Breast Cancer
  • Breast Cancer

Interventions

DrugSynonymsArms
LetrozoleFemara1
BevacizumabAvastin2

Purpose

The purpose of this study is to evaluate the objective response rate of a combination of letrozole (Femara) and bevacizumab (Avastin) given preoperatively to postmenopausal patients with hormone sensitive breast cancer.

Trial Arms

NameTypeDescriptionInterventions
1Active Comparatorbrief exposure bevacizumab
  • Letrozole
2Active Comparatorbrief exposure bevacizumab and letrozole
  • Bevacizumab

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed operable or potentially operable invasive breast
             adenocarcinoma that is clinically palpable and measurable

          -  Age ≥ 18 years

          -  Clinical Stage T2-4, N0-3, M0 (Stage II-III)

          -  Postmenopausal defined as Age ≥ 60 years and/or Age >45 years with amenorrhea 12
             months with an intact uterus and/or History of bilateral oophorectomy and/or FSH and
             estradiol levels in postmenopausal range

          -  ECOG PS 0, 1

          -  Unifocal disease

          -  ER and/or PR positive

          -  Adequate hematological, renal, and hepatic functions Absolute neutrophil count ≥
             1,500/µL Platelet count ≥ 100,000/µL creatinine ≤ 1.5 mg/dL Serum total bilirubin ≤
             1.5 mg/dL Alkaline phosphatase ≤ 3X the ULN for the reference lab SGOT/SGPT ≤ 3X the
             ULN for the reference lab

          -  Patients or their legal representatives must be able to read, understand and provide
             informed consent to participate in the trial

          -  Use of effective means of contraception (men and women) in subjects of child-bearing
             potential

        Exclusion Criteria:

          -  Prior history of and/or therapy for invasive breast cancer (includes chemotherapy,
             radiation, hormonal therapy including AIs, tamoxifen, raloxifene, fulvestrant or any
             other antiestrogen/SERM)

          -  Clinically significant cardiovascular disease, EF <50%

          -  Known CNS disease

          -  History of deep vein thrombosis or pulmonary embolism

          -  Proteinuria at screening as demonstrated by either Urine protein:creatinine (UPC)
             ratio ≥ 1.0 at screening OR Urine dipstick for proteinuria ≥ 2+ (patients discovered
             to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour
             urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).

          -  Presence of non-healing wound or fracture

          -  Current, recent (within 4 weeks of the first infusion of this study), or planned
             participation in an experimental drug study other than a Genentech-sponsored
             bevacizumab cancer study

          -  Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or
             diastolic blood pressure > 100 mmHg on antihypertensive medications)

          -  Any prior history of hypertensive crisis or hypertensive encephalopathy

          -  New York Heart Association (NYHA) Grade II or greater congestive heart failure (see
             Appendix E)

          -  History of myocardial infarction or unstable angina within 12 months prior to study
             enrollment

          -  Any history of stroke or transient ischemic attack at any time

          -  Significant vascular disease (e.g., aortic aneurysm, aortic dissection)

          -  Symptomatic peripheral vascular disease

          -  Evidence of bleeding diathesis or coagulopathy

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to Day 0

          -  Core biopsy or other minor surgical procedures such as fine needle aspirations or core
             biopsies within 7 days prior to Day 0

          -  Pregnant (positive pregnancy test) or lactating. Use of effective means of
             contraception (men and women) in subjects of child-bearing potential is mandatory

          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
             within 6 months prior to Day 0

          -  Known hypersensitivity to any component of bevacizumab or letrozole

          -  Inability to comply with study and/or follow-up procedures
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:To assess clinical objective tumor response with 14 weeks of neoadjuvant letrozole combined with bevacizumab
Time Frame:Upon completion of study
Safety Issue:
Description:

Secondary Outcome Measures

Measure:To assess breast conservation rates (actual surgery performed and baseline feasible surgery) of 14 weeks of neoadjuvant letrozole combined with bevacizumab
Time Frame:14 weeks
Safety Issue:
Description:
Measure:To assess radiographic tumor response (ultrasound, mammogram, MRI) after 14 weeks of neoadjuvant letrozole combined with bevacizumab
Time Frame:14 weeks
Safety Issue:
Description:
Measure:To assess pathologic complete response after 14 weeks of neoadjuvant letrozole combined with bevacizumab
Time Frame:14 weeks
Safety Issue:
Description:
Measure:To correlate response with biological correlates detected at baseline and after 1 cycle of treatment with either bevacizumab alone or bevacizumab combined with letrozole
Time Frame:2 weeks
Safety Issue:
Description:
Measure:To assess the tolerability of 14 weeks of neoadjuvant letrozole combined with bevacizumab
Time Frame:14 weeks
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Unknown status
Lead Sponsor:Yale University

Trial Keywords

  • Neoadjuvant treatment

Last Updated

June 5, 2009