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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Novartis
Genentech, Inc.
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00461773
First received: April 16, 2007
Last updated: June 5, 2009
Last verified: June 2009

April 16, 2007
June 5, 2009
March 2007
May 2010   (final data collection date for primary outcome measure)
To assess clinical objective tumor response with 14 weeks of neoadjuvant letrozole combined with bevacizumab [ Time Frame: Upon completion of study ] [ Designated as safety issue: No ]
To assess clinical objective tumor response with 14 weeks of neoadjuvant letrozole combined with bevacizumab
Complete list of historical versions of study NCT00461773 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • To assess radiographic tumor response (ultrasound, mammogram, MRI) after 14 weeks of neoadjuvant letrozole combined with bevacizumab [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • To assess pathologic complete response after 14 weeks of neoadjuvant letrozole combined with bevacizumab [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To assess the tolerability of 14 weeks of neoadjuvant letrozole combined with bevacizumab [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • To assess breast conservation rates (actual surgery performed and baseline feasible surgery) of 14 weeks of neoadjuvant letrozole combined with bevacizumab
  • To assess radiographic tumor response (ultrasound, mammogram, MRI) after 14 weeks of neoadjuvant letrozole combined with bevacizumab
  • To assess pathologic complete response after 14 weeks of neoadjuvant letrozole combined with bevacizumab
  • To correlate response with biological correlates detected at baseline and after 1 cycle of treatment with either bevacizumab alone or bevacizumab combined with letrozole
  • To assess the tolerability of 14 weeks of neoadjuvant letrozole combined with bevacizumab
Not Provided
Not Provided
 
Randomized Phase II Study of Preoperative Letrozole (Femara) in Combination With Avastin in Hormone Receptor Positive Breast Cancer
Randomized Phase II Study of Preoperative Letrozole (Femara) in Combination With Avastin in Hormone Receptor Positive Breast Cancer

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hormone-Sensitive Breast Cancer
  • Breast Cancer
  • Drug: Letrozole
    Letrozole 2.5 mg po qd
    Other Name: Femara
  • Drug: Bevacizumab
    bevacizumab 10 mg/kg IV
    Other Name: Avastin
  • Active Comparator: 1
    brief exposure bevacizumab
    Intervention: Drug: Letrozole
  • Active Comparator: 2
    brief exposure bevacizumab and letrozole
    Intervention: Drug: Bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Jeannie Kluytenaar, RN 203-785-6523 jeannie.kluytenaar@yale.edu
Contact: Michele Alguard 203-737-5908 Michele.alguard@yale.edu
United States
 
NCT00461773
0609001793
No
Gina Chung, M.D., Principal Investigator, Yale University School of Medicine
Yale University
  • Novartis
  • Genentech, Inc.
Principal Investigator: Gina Chung, M.D. Yale University
Yale University
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP