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Comparing Letrozole Given Alone to Letrozole Given With Avastin in Post-Menopausal Women Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Comparing Letrozole Given Alone to Letrozole Given With Avastin in Post-Menopausal Women Breast Cancer

A Phase II, Randomized, Open Label Trial of Pre-operative (Neoadjuvant)Letrozole (Femara) vs. Letrozole in Combination With Avastin in Post Menopausal Women With Newly Diagnosed Operable Breast Cancer

NCT00530868•University of Alabama at Birmingham

View on ClinicalTrials.gov

Summary

This purpose of this trial is to show that the combination of Avastin and hormone therapy should be more effective than hormone therapy alone for the treatment of breast cancer.

Detailed Description

Preclinical and clinical data have demonstrated that up-regulation of tumor cell VEGF is an important mechanism to subvert estrogen dependence in hormone responsive breast cancer resulting in reduced therapy response or tumor resistance to hormonal therapy; thus, it is hypothesized that the combination of an anti-VEGF agent (Avastin, an anti-VEGF monoclonal antibody) and hormonal therapy should be more effective than hormonal therapy alone for the treatment of breast cancer.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•All patients must meet the following criteria to be eligible for study entry:
•Pathologically confirmed invasive ductal carcinoma or invasive lobular carcinoma of the breast, T2-T3 / T4a-c / N0-2 / M0, with positive estrogen and/or progesterone receptors, and Her-2-neu negative. Patients with inflammatory breast cancer will not be included (T4d). Patients previously treated patients with no measurable disease or patients with metastatic disease will be excluded.
•Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
•Patients must be postmenopausal, defined as one of the following:
•* Patients \> 50 years of age with no spontaneous menses for at least 12 months,
•* Bilateral oophorectomy
•Be ambulatory (outpatient) and have an ECOG PS \<1.
•Patients must have measurable disease by mammogram and/or breast ultrasound (in special cases a dedicated breast MRI may be clinically indicated). The target lesion must not have been previously irradiated.
•No prior chemotherapy.
•Patients must have adequate organ and marrow function as defined as follows: absolute neutrophil count \> 1,500/mm3, hemoglobin \> 8.0 g/dl, platelets \> 75,000/mm3, total bilirubin \< 2 mg/dl, serum creatinine \< 2 mg/dl, Transaminases (AST, ALT) may be up to 2 x institutional upper limit of normal. In addition \< 1 gr of protein in 24 hr urine collection and urine protein/creatinine ratio \< 1.0.
+4 more criteria

Exclusion Criteria

•Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than this sponsor-investigator Bevacizumab cancer study.
•Uncontrolled high blood pressure (\>150/100 mmHg).
•Unstable angina
•New York Heart Association (NYHA) Grade III or greater congestive heart failure
•History of myocardial infarction or unstable angina within 12 months
•History of stroke or TIA within 12 months
•Clinically significant peripheral vascular disease
•History of a bleeding disorder
•Presence of central nervous system or brain metastases
•Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
+9 more criteria

Locations (7)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of California, San Francisco Comprehensive Cancer Center

San Francisco, California, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Georgia Cancer Specialists

Atlanta, Georgia, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Key Dates

Start Date

October 8, 2007

Primary Completion Date

March 1, 2022

Completion Date

March 31, 2022

Last Updated

October 21, 2022

Enrollment

ACTUAL participants

Conditions

Breast CancerCancer of the BreastBreast Neoplasm

Interventions

Letrozole (Femara)

OTHER

Letrozole; Avastin

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 21, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Comparing Letrozole Given Alone to Letrozole Given With Avastin in Post-Menopausal Women Breast Cancer

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

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Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer