Metastatic Breast CancerPhase 2NCT00240071
Study of Avastin (Bevacizumab) to Reverse Acquired Estrogen Independence in Previously Hormone Responsive Metastatic Breast Ca.
A Phase 2 study testing Avastin and Hormonal therapy in people with Metastatic Breast Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to determine if acquired hormone therapy resistance can be reversed by Avastin (Bevacizumab), as measured by time to disease progression and evaluate toxicity of the combination of hormone treatment plus Avastin (Bevacizumab). Read more about this study
- Who is it for?
- Ages 19 to 80 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Avastin and Hormonal therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Apr 2011
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have cytologically or histologically proven breast cancer which is estrogen receptor or progesterone receptor positive and is locally advanced and /or metastatic.
- 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 (Appendix E).
- Be female and greater than or equal to 19 years of age (age limit required by the State of Alabama). Women of childbearing potential must have a negative pregnancy test and must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Be ambulatory (outpatient) and have an Eastern Cooperative Oncology Group (ECOG) PS <2 (Appendix B).
- Previous treatment: Patients must have responded to first or second line hormonal therapy (Partial and complete response greater than 6 months using RECIST criteria. Patients with stable disease for more than 6 months will be eligible) and became resistant to the hormonal agent. They must remain on the current hormone therapy to which they initially responded but now are resistant.
- Clear documentation of acquired hormonal resistance.
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- Evaluable disease will be considered eligible, but measurable disease according to RECIST criteria will be preferable (Appendix C). The target lesion(s) must not have been previously irradiated (newly arising lesions in previously irradiated areas are acceptable).
- 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 2.5 x institutional upper limit of normal for patients with no liver metastases and up to 5 x institutional upper normal limit for patients with documented liver metastases. In addition < 1 gr of protein in 24 hr urine collection and urine protein/creatinine ratio < 1.0
- Prior chemotherapy does not exclude patients from study as long as the current therapy was hormonal therapy alone.
- Patients with de novo hormone therapy resistance will not be eligible.
- No life threatening parenchymal disease or rapidly progressing disease warranting cytotoxic chemotherapy.
- No history of brain metastases.
- No history of thrombosis during the previous year, including transient ischemic attack.
- Hypertension must be controlled (< 150/100 mmHg).
- Ejection Fraction > 50%.
Who cannot join
- Patients who are "de novo" resistant to hormone therapy.
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than this Genentech-sponsored bevacizumab cancer study.
- Blood pressure of >150/100 mmHg
- Unstable angina
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- History of myocardial infarction within 6 months
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- 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 greater than or equal to 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.
- Previously radiated area(s) must not be the only site of disease.
- History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: The Study of Avastin (Bevacizumab) to Reverse Acquired Estrogen Independence in Metastatic Breast Cancer Patients Previously Responsive to Hormonal Therapy: A Phase II Trial
The purpose of this study is to determine if acquired hormone therapy resistance can be reversed by Avastin (Bevacizumab), as measured by time to disease progression and evaluate toxicity of the combination of hormone treatment plus Avastin (Bevacizumab).
Read the detailed description
This is a single institution, open-label study designed to evaluate safety and efficacy of Avastin (Bevacizumab) combined with an endocrine agent in patients with estrogen and/or progesterone receptor positive metastatic breast carcinoma who have acquired resistance to at least one hormonal agent. Patients will be treated with the same hormonal agent that was used previously assuming that the patient had a partial or complete response (for at least 6 months) followed by a clear disease progression using the Response Evaluation Criteria in solid Tumors (RECIST Criteria). Patients with stable disease for a prolonged time (for at least 6 months) will be also eligible to enter in the trial. Patients who have not had interval studies to evaluate disease response will be considered eligible if they have remained clinically stable (i.e. stable performance status (PS), no increasing pain) and on the same hormone for at least 6 months, and now they have signs and symptoms of clinical progression (i.e. elevated tumor markers, increasing bone pain, worsening performance status). Patients must have histologically confirmed measurable and/or evaluable metastatic breast cancer with positive estrogen and/or progesterone receptors. Patients can have up to an 8-12 week break in therapy (discontinuation of hormonal therapy) and still remain eligible for the study as long as the documentation of disease progression is determined before the 8-12 week break in hormonal therapy.
The type and dose of the hormonal agent that will be used in this trial will be the same one that the patient used before progression. Hormonal therapy may include any estrogen deprivation reagent such as Tamoxifen, Anastrazole, Exemestane, Letrozole, or Fulvestrant. All patients will receive Avastin (Bevacizumab) 15 mg/kg IV every three weeks. Based on statistical evaluations, 30 patients will be enrolled. The first evaluation of efficacy will be done at week 6; patients with objective response or stable disease will continue therapy with re-staging every 6 weeks until evidence of disease progression. Patients with progression of disease will be taken off study (see appendix A). PET scan will be done at baseline and only in the first evaluation (6 weeks) to obtain early "metabolic response data" that will be correlated with objective response and time to disease progression (PET data on week 6 will not be used to evaluate response and to make therapeutic decisions). PET "metabolic response" will be defined as a >20% reduction in Standardized Uptake Value (SUV). Safety will be assessed by the recording of adverse events, serious adverse events, laboratory test results, and changes in vital signs. A positive response to Avastin (Bevacizumab) (reversal of hormonal resistance) will be defined as an objective response or stable disease of ≥ 3 months duration. All concomitant medication must be documented. Additionally, any diagnostic, therapeutic or surgical procedure performed during the study period, should be recorded including the date, indication, description of the procedure(s) and any clinical findings.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Avastin, Hormonal therapy
- Keywords
- Breast cancer, Metastatic breast cancer, Hormonal therapy, Bevacizumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvastinDrug
Also called Bevacizumab
All patients will received Avastin 15 mg/kg IV every three weeks. The first evaluation will be done at Week 6. Patients with objective response or stable disease will continue therapy with restaging every 6 weeks until evidence of disease progression. Patients with progression of disease will be taken off study.
Hormonal therapyDrug
Also called Femara (letrozole), Arimidex (anastrazole), Aromasin (exemestane), Nolvadex (tamoxifen)
aromatase inhibitor (letrozole 2.5mg/d PO, anastrazole 1mg/d PO, or exemestane 25mg/d PO)or Selective Estrogen Receptor Modulator (SERM) (tamoxifen 20mg/d PO)
| Study group | Role | What they receive |
|---|---|---|
| Avastin | Experimental | The patient will continue the same hormonal therapy used prior to study enrollment but will combine it with Avastin. Receives: Drug: Avastin; Drug: Hormonal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Progression free survival is defined as time from date of registration until the date of first documented disease progression or date of death from any cause, whichever occurs first.
Measured: From date of registration until disease progression or death, whichever occurs first
Secondary outcomes (1)
Objective Response Rate (Defined as the Rate of Complete and Partial Responses).
Measured: From date of registration until disease progression or death, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionMar 2009
- Study completionApr 2011
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 Metastatic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Carla Falkson, MD, University of Alabama at Birmingham
- Investigators
- Carla Falkson, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240071
- Sponsor's protocol ID
- F050103001
- Other IDs
- UAB 0461
- Status last verified
- Oct 2019
- First submitted
- 13 Oct 2005
- Last updated
- 30 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Avastin (Bevacizumab) to Reverse Acquired Estrogen Independence in Metastatic Breast Cancer Patients Previously Responsive to Hormonal Therapy: A Phase II Trial
- ClinicalTrials.gov ID
- NCT00240071
- Acronym / sponsor ID
- F050103001
- Conditions
- Metastatic Breast Cancer
- Keywords
- Breast cancer, Metastatic breast cancer, Hormonal therapy, Bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Oct 2005
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 17 Oct 2005 (estimated)
- Results
- Posted 27 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if acquired hormone therapy resistance can be reversed by Avastin (Bevacizumab), as measured by time to disease progression and evaluate toxicity of the combination of hormone treatment plus Avastin (Bevacizumab).
Detailed description
This is a single institution, open-label study designed to evaluate safety and efficacy of Avastin (Bevacizumab) combined with an endocrine agent in patients with estrogen and/or progesterone receptor positive metastatic breast carcinoma who have acquired resistance to at least one hormonal agent. Patients will be treated with the same hormonal agent that was used previously assuming that the patient had a partial or complete response (for at least 6 months) followed by a clear disease progression using the Response Evaluation Criteria in solid Tumors (RECIST Criteria). Patients with stable disease for a prolonged time (for at least 6 months) will be also eligible to enter in the trial. Patients who have not had interval studies to evaluate disease response will be considered eligible if they have remained clinically stable (i.e. stable performance status (PS), no increasing pain) and on the same hormone for at least 6 months, and now they have signs and symptoms of clinical progression (i.e. elevated tumor markers, increasing bone pain, worsening performance status). Patients must have histologically confirmed measurable and/or evaluable metastatic breast cancer with positive estrogen and/or progesterone receptors. Patients can have up to an 8-12 week break in therapy (discontinuation of hormonal therapy) and still remain eligible for the study as long as the documentation of disease progression is determined before the 8-12 week break in hormonal therapy.
The type and dose of the hormonal agent that will be used in this trial will be the same one that the patient used before progression. Hormonal therapy may include any estrogen deprivation reagent such as Tamoxifen, Anastrazole, Exemestane, Letrozole, or Fulvestrant. All patients will receive Avastin (Bevacizumab) 15 mg/kg IV every three weeks. Based on statistical evaluations, 30 patients will be enrolled. The first evaluation of efficacy will be done at week 6; patients with objective response or stable disease will continue therapy with re-staging every 6 weeks until evidence of disease progression. Patients with progression of disease will be taken off study (see appendix A). PET scan will be done at baseline and only in the first evaluation (6 weeks) to obtain early "metabolic response data" that will be correlated with objective response and time to disease progression (PET data on week 6 will not be used to evaluate response and to make therapeutic decisions). PET "metabolic response" will be defined as a >20% reduction in Standardized Uptake Value (SUV). Safety will be assessed by the recording of adverse events, serious adverse events, laboratory test results, and changes in vital signs. A positive response to Avastin (Bevacizumab) (reversal of hormonal resistance) will be defined as an objective response or stable disease of ≥ 3 months duration. All concomitant medication must be documented. Additionally, any diagnostic, therapeutic or surgical procedure performed during the study period, should be recorded including the date, indication, description of the procedure(s) and any clinical findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avastin | Experimental | Drug: Avastin, Drug: Hormonal therapyThe patient will continue the same hormonal therapy used prior to study enrollment but will combine it with Avastin. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must have cytologically or histologically proven breast cancer which is estrogen receptor or progesterone receptor positive and is locally advanced and /or metastatic.
- 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 (Appendix E).
- Be female and greater than or equal to 19 years of age (age limit required by the State of Alabama). Women of childbearing potential must have a negative pregnancy test and must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Be ambulatory (outpatient) and have an Eastern Cooperative Oncology Group (ECOG) PS <2 (Appendix B).
- Previous treatment: Patients must have responded to first or second line hormonal therapy (Partial and complete response greater than 6 months using RECIST criteria. Patients with stable disease for more than 6 months will be eligible) and became resistant to the hormonal agent. They must remain on the current hormone therapy to which they initially responded but now are resistant.
Key exclusion criteria (20 listed)
- Patients who are "de novo" resistant to hormone therapy.
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than this Genentech-sponsored bevacizumab cancer study.
- Blood pressure of >150/100 mmHg
- Unstable angina
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
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 |
|---|---|---|
| AvastinAlso: BevacizumabAll patients will received Avastin 15 mg/kg IV every three weeks. The first evaluation will be done at Week 6. Patients with objective response or stable disease will continue therapy with restaging every 6 weeks until evidence of disease progression. Patients with progression of disease will be taken off study. | Drug | Avastin |
| Hormonal therapyAlso: Femara (letrozole), Arimidex (anastrazole), Aromasin (exemestane), Nolvadex (tamoxifen)aromatase inhibitor (letrozole 2.5mg/d PO, anastrazole 1mg/d PO, or exemestane 25mg/d PO)or Selective Estrogen Receptor Modulator (SERM) (tamoxifen 20mg/d PO) | Drug | Avastin |
Primary outcome
Progression Free Survival (PFS)
Time frame: From date of registration until disease progression or death, whichever occurs first
Progression free survival is defined as time from date of registration until the date of first documented disease progression or date of death from any cause, whichever occurs first.
1 secondary outcome
Objective Response Rate (Defined as the Rate of Complete and Partial Responses).
Time frame: From date of registration until disease progression or death, whichever occurs first
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Carla Falkson, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avastin and Hormonal therapy in people with Metastatic Breast Cancer, run by University of Alabama at Birmingham at 1 site 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 15 inclusion and 20 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 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 27 Sep 2011). 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?
Progression Free Survival (PFS) (time frame: From date of registration until disease progression or death, whichever occurs first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2019.