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

Information source: Yale University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hormone-Sensitive Breast Cancer; Breast Cancer

Intervention: Letrozole (Drug); Bevacizumab (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Yale University

Official(s) and/or principal investigator(s):
Gina Chung, M.D., Principal Investigator, Affiliation: Yale University

Overall contact:
Jeannie Kluytenaar, RN, Phone: 203-785-6523, Email: jeannie.kluytenaar@yale.edu

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To assess clinical objective tumor response with 14 weeks of neoadjuvant letrozole combined with bevacizumab

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

Jeannie Kluytenaar, RN, Phone: 203-785-6523, Email: jeannie.kluytenaar@yale.edu

Yale University, Yale Cancer Center, New Haven, Connecticut 06520, United States; Recruiting
Additional Information

Starting date: March 2007
Last updated: June 5, 2009

Page last updated: August 20, 2015

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