Open Label Trial for Post-Menopausal Women With Newly Diagnosed Operable Breast Cancer
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ClinicalTrials.gov Identifier: NCT00161291 |
Recruitment Status :
Completed
First Posted : September 12, 2005
Last Update Posted : January 4, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Drug: Letrozole in combination with Bevacizumab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 28 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Open Label Trial of Pre-Operative (Neoadjuvant) Letrozole in Combination With Bevacizumab in Post-Menopausal Women With Newly Diagnosed Operable Breast Cancer |
Study Start Date : | June 2005 |
Actual Primary Completion Date : | November 2006 |
Actual Study Completion Date : | November 2006 |
- Drug: Letrozole in combination with Bevacizumab
Patients will be administered Letrozole at 2.5 mg PO a day and Avastin at 15 mg/kg IV every 3 weeks for 24 weeks. Patients will then undergo surgical treatment and receive adjuvant therapy according to the treating physician.Other Names:
- Letrozole (Femara)
- Bevacizumab (Avastin)
- The primary objective is to estimate the pathological complete response rate of neoadjuvant therapy in operable newly diagnosed ER+ breast cancer patients using the combination of Avastin and Letrozole. [ Time Frame: approximately 24 weeks ]
- A clinical response will be based upon the Response Evaluation Criteria in Solid Tumors (RECIST Criteria). [ Time Frame: approximately 24 weeks ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Pathologically confirmed invasive ductal carcinoma or invasive lobular carcinoma of the breast, T2-T4 / T4a-c / N0-2 / M0, with positive estrogen and/or progesterone receptors. Patients with inflammatory breast cancer will not be included (Stage IIIb). Patients previously treated patients with no measurable disease or patients with metastatic disease will be excluded.
- 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 (see Appendix B - consent form).
- Females 60 years of age (postmenopausal).
- Be ambulatory (outpatient) and have an ECOG PS <2 (Appendix F).
- Patients must have measurable disease by mammogram and/or breast ultrasound. 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 2.0 x institutional upper limit of normal. In addition < 1 gr of protein in 24 hr urine collection and urine protein/creatinine ratio < 1.0.
- No life threatening parenchymal disease or rapidly progressing disease warranting cytotoxic chemotherapy.
- Hypertension must be controlled (<150/100 mmHg).
- Ejection Fraction > 50%.
- No history of thrombosis during the previous year.
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 II or greater congestive heart failure see Appendix G)
- History of myocardial infarction within 6 months
- History of stroke within 6 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
- Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0
- Pregnant (positive pregnancy test) or lactating
- Urine protein: creatinine ratio 1.0 at screening. Patients demonstrating > 1 gr of protein in 24 hr urine collection within 4 weeks prior to study entry will not participate in the trial.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
- Serious, non-healing wound, ulcer, or bone fracture
- Unwilling or unable to comply with the protocol for the duration of the study.
- Psychiatric illness/social situations that would limit compliance with study requirements.
- History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix.
- Patients with metastatic disease.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161291
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 |
Principal Investigator: | Andres Forero-Torres, MD | University of Alabama at Birmingham |
Responsible Party: | Andres Forero, M.D., UAB |
ClinicalTrials.gov Identifier: | NCT00161291 |
Other Study ID Numbers: |
F041222006 UAB 0467 ( Other Identifier: Institutional protocol study number ) |
First Posted: | September 12, 2005 Key Record Dates |
Last Update Posted: | January 4, 2011 |
Last Verified: | December 2010 |
Carcinoma of the breast Breast cancer |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Bevacizumab Letrozole Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents |
Growth Substances Physiological Effects of Drugs Growth Inhibitors Aromatase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |