Breast CancerPhase 2NCT00530868

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

A Phase 2 study testing Letrozole (Femara) and Letrozole; Avastin in people with Breast Cancer and Cancer of the Breast, run by University of Alabama at Birmingham at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Breast Cancer, Cancer of the Breast, Breast Neoplasm
What is being tested?: Letrozole (Femara) and Letrozole; Avastin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: 7 sitesUnited States
Study dates: 8 Oct 2007to 31 Mar 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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.
No life threatening parenchymal disease or rapidly progressing disease warranting cytotoxic chemotherapy.
Hypertension must be controlled (<150/100 mmHg).
Ejection Fraction > 50% by echocardiogram. (LVEF greater than 75% at baseline should be reviewed and/or the test repeated as it may be falsely elevated).
No history of thrombosis during the previous 12 months.

Who cannot join

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

Show all 19Show fewer

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 (excluding fine needle aspirations or core biopsies) within 5 days prior to Day 0
Pregnant (positive pregnancy test) or lactating
Urine protein: creatinine ratio greater than or equal to 1.0 at screening or 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 non-melanoma skin cancer and carcinoma in-situ of uterine cervix.
Patients with metastatic disease.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Georgia Cancer Specialists
Atlanta, Georgia, 30341
University of Alabama at Birmingham
Birmingham, Alabama, 35294 - 0104
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
University of of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7600
University of Chicago Medical Center
Chicago, Illinois, 60637
University of California, San Francisco Comprehensive Cancer Center
San Francisco, California, 94115
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: 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

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.

Read the 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.

Conditions: Breast Cancer, Cancer of the Breast, Breast Neoplasm
Being tested: Letrozole (Femara), Letrozole; Avastin
Keywords: Hormonal and antibody therapy for breast cancer, Hormonal therapy for breast cancer, Antibody therapy for breast cancer
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Letrozole (Femara)Other
Letrozole 2.5 mg PO a day for 24 weeks
Letrozole; AvastinDrug
Also called Femara (Letrozole)
Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks

Study groups in NCT00530868
Study group	Role	What they receive
Letrozole + Avastin	Experimental	50 evaluable patients received the combination therapy of 2.5 gm daily oral Letrozole and Avastin 15 mg/kg IV every 3 weeks for 24 weeks. Receives: Drug: Letrozole; Avastin
Letrozole alone	Experimental	25 evaluable patients received daily oral 2.5 mg letrozole as a single agent Receives: Other: Letrozole (Femara)

What is being measured

The primary outcome is the main question the study is designed to answer.

The Percentage of Participants With Pathologic Complete Response
Pathological complete response is defined as the absence of residual invasive tumor in the breast or axillary lymph nodes or if only residual ductal carcinoma in-situ was seen on review of the surgical specimen.
Measured: 24 weeks

Secondary outcomes (1)

Letrozole +Avastin
Radiographic objective response to the therapy are reported. Radiographic response was assessed using RECIST criteria by ultrasound or breast MRI through the study and are reported as complete radiographic response below.
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Oct 200731 Mar 2022

First posted18 Sep 2007 (estimated)
Study start8 Oct 2007
Primary completion1 Mar 2022
Study completion31 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00530868
Sponsor's protocol ID: F061229006
Other IDs: UAB 0648
Status last verified: Sep 2022
First submitted: 14 Sep 2007
Last updated: 21 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00530868
Acronym / sponsor ID: F061229006
Conditions: Breast Cancer, Cancer of the Breast, Breast Neoplasm
Keywords: Hormonal and antibody therapy for breast cancer, Hormonal therapy for breast cancer, Antibody therapy for breast cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: University of Alabama at BirminghamUniversity, hospital or other
Collaborators: Genentech, Inc., Breast Cancer Research Foundation
Study start: 8 Oct 2007 (actual)
Primary completion: 1 Mar 2022 (actual)
Study completion: 31 Mar 2022 (actual)
First posted: 18 Sep 2007 (estimated)
Results: Posted 21 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Letrozole + Avastin	Experimental	Drug: Letrozole; Avastin50 evaluable patients received the combination therapy of 2.5 gm daily oral Letrozole and Avastin 15 mg/kg IV every 3 weeks for 24 weeks.
Letrozole alone	Experimental	Other: Letrozole (Femara)25 evaluable patients received daily oral 2.5 mg letrozole as a single agent

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

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:
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.

Key exclusion criteria (19 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Letrozole (Femara)Letrozole 2.5 mg PO a day for 24 weeks	Other	Letrozole alone
Letrozole; AvastinAlso: Femara (Letrozole)Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks	Drug	Letrozole + Avastin

Primary outcome

The Percentage of Participants With Pathologic Complete Response
Time frame: 24 weeks
Pathological complete response is defined as the absence of residual invasive tumor in the breast or axillary lymph nodes or if only residual ductal carcinoma in-situ was seen on review of the surgical specimen.

1 secondary outcome

Letrozole +Avastin
Time frame: 24 weeks

Results and safety

Results posted to the registry on 21 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Letrozole + Avastin	50	50
Letrozole Alone	25	25

Primary outcome: The Percentage of Participants With Pathologic Complete Response

Time frame: 24 weeks. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Letrozole + Avastin n = 50	Letrozole Alone n = 25
Value	11 (3.7 to 24.1)	0 (0 to 14.2)

Population analysed: Patients with postmenopausal hormone receptor positive breast cancer T2-4,N0-2 and M0 were randomized 2:1 to receive letrozole 2.5 mg PO daily and bevacizumab 15 mg/kg IV for 24 weeks or daily treatment with letrozole 2.5 mg PO alone (control arm). The duration of each cycle was 3 weeks for a total of 24 weeks. The pCR was defined as the absence of any residual invasive cancer in the resected breast specimen and lymph nodes. Data below is representative of the raw data.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 24 weeks of active treatment. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Letrozole + Avastin	2 of 50 (4%)	2 of 50 (4%)	0 of 50
Letrozole Alone	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Not yet recruitingObservational study
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Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lisle Nabell, M.D. principal investigator

University of Alabama at Birmingham

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Letrozole (Femara) and Letrozole; Avastin in people with Breast Cancer and Cancer of the Breast, run by University of Alabama at Birmingham at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Percentage of Participants With Pathologic Complete Response (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00530868.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.