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Hormone Therapy
Hormone Therapy + Immunotherapy for Advanced Breast Cancer
Phase 3
Waitlist Available
Led By Hope S Rugo
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologic confirmation of invasive cancer of the female breast in either the primary or metastatic setting
Tumors must express estrogen receptor (ER) and/or progesterone receptor (PgR) in >= 1% of cells
Must not have
Currently active second malignancy other than non-melanoma skin cancers
Anticipation of need for major surgical procedure during the course of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial is testing tamoxifen citrate or letrozole with or without bevacizumab to treat stage IIIB or IV breast cancer. Estrogen fuels breast cancer cell growth, so hormone therapy with tamoxifen or letrozole can block estrogen and stop tumor growth. Bevacizumab is an immunotherapy that may help the body's immune system fight the cancer. Researchers want to see if it is more effective with or without bevacizumab.
Who is the study for?
This trial is for postmenopausal women or premenopausal women on ovarian suppression with stage IIIB or IV breast cancer that responds to hormones. Participants should not have had major surgery recently, no history of significant bleeding, fistulas, or abdominal abscesses, and no severe cardiovascular issues. They must have a life expectancy of at least 12 weeks and be in good physical condition (ECOG <=1).
What is being tested?
The study is testing the effectiveness of hormone therapies tamoxifen citrate or letrozole alone versus combined with the monoclonal antibody bevacizumab in advanced breast cancer. The goal is to see if adding bevacizumab improves outcomes by altering the immune system's response to tumor cells.
What are the potential side effects?
Bevacizumab can cause high blood pressure, increased risk of bleeding and blood clots, headaches, mouth sores, and proteinuria (excess protein in urine). Tamoxifen may lead to hot flashes, vaginal discharge or bleeding, and an increased risk of blood clots. Letrozole side effects include bone pain, cholesterol changes, fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer has been confirmed by tissue analysis.
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My tumor is positive for estrogen or progesterone receptors.
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I am a woman who has gone through menopause or am premenopausal with ovarian suppression.
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I don't expect to need any major surgery while in the study.
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I haven't had any major abdominal issues or bleeding recently.
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I have no allergies to AI or tamoxifen medications.
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I can carry out all my self-care but cannot do heavy physical work.
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I do not have any serious wounds, ulcers, or broken bones that are not healing.
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My kidney function test shows less than 1g of protein in my urine over 24 hours.
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I have never had a stroke, transient ischemic attack, or cancer spread to my brain.
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My cancer is at stage IV or inoperable stage IIIB.
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I do not have any major heart problems.
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I am not pregnant.
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My blood clotting time is normal or I'm on warfarin.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have another active cancer besides non-melanoma skin cancer.
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I expect to need a major surgery during the study.
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I am allergic to certain drugs used in AI or tamoxifen treatment.
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I need some help with my daily activities.
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I had a biopsy or minor surgery within the last week.
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I have not had serious abdominal issues or significant bleeding recently.
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I have a serious heart condition.
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I have had a stroke, a transient ischemic attack, or cancer that has spread to my brain.
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I am not postmenopausal and not undergoing ovarian suppression.
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I have been treated with anti-VEGF or VEGFR inhibitors before.
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I have a serious wound or fracture that is not healing.
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My INR is over 1.6 and I am not on full dose warfarin.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-free Survival
Secondary study objectives
12 Month Progression Free Survival Rate
6 Month Progression-Free Survival Rate
Duration of Tumor Response
+4 moreSide effects data
From 2018 Phase 4 trial • 79 Patients • NCT0213753810%
Fracture
8%
Acne
5%
Scoliosis
3%
Hair loss
3%
Sacroiliitis
3%
Neuro event
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anastrozole
Letrozole
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (endocrine therapy with monoclonal antibody)Experimental Treatment5 Interventions
Patients receive endocrine therapy\* (tamoxifen citrate\* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (endocrine therapy)Active Control4 Interventions
Patients receive endocrine therapy\* (tamoxifen citrate\* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5540
Tamoxifen Citrate
2011
Completed Phase 3
~3780
Letrozole
2002
Completed Phase 4
~3590
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,606 Total Patients Enrolled
945 Trials studying Breast Cancer
1,543,964 Patients Enrolled for Breast Cancer
Hope S RugoPrincipal InvestigatorAlliance for Clinical Trials in Oncology
1 Previous Clinical Trials
799 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your platelet count is less than 100,000 per microliter.Your creatinine level is higher than 2.0 mg/dL.My kidney function test shows less than 1g of protein in my urine over 24 hours.My breast cancer has been confirmed by tissue analysis.The amount of protein in your urine is low.I have another active cancer besides non-melanoma skin cancer.I haven't had major surgery or a serious injury recently.I expect to need a major surgery during the study.I am allergic to certain drugs used in AI or tamoxifen treatment.I need some help with my daily activities.My tumor is positive for estrogen or progesterone receptors.I finished chemotherapy at least a year ago.I don't expect to need any major surgery while in the study.I haven't had any major abdominal issues or bleeding recently.I have no allergies to AI or tamoxifen medications.I am a woman who has gone through menopause or am premenopausal with ovarian suppression.I can carry out all my self-care but cannot do heavy physical work.I do not have any serious wounds, ulcers, or broken bones that are not healing.My bilirubin levels are normal or slightly elevated due to Gilbert's syndrome.I had a biopsy or minor surgery within the last week.I have not had serious abdominal issues or significant bleeding recently.I have not had hormone therapy for my condition.I finished my radiotherapy at least two weeks ago.I haven't had major surgery or a serious injury in the last 28 days.I have never had a stroke, transient ischemic attack, or cancer spread to my brain.Your liver enzymes (ALT, AST) are not more than 2.5 times the normal level.I have a serious heart condition.I have had a stroke, a transient ischemic attack, or cancer that has spread to my brain.I am not postmenopausal and not undergoing ovarian suppression.I have not had hormone therapy for cancer that has spread, unless under certain conditions.I have been treated with anti-VEGF or VEGFR inhibitors before.I have a serious wound or fracture that is not healing.You are expected to live for less than 12 weeks.You have a low number of granulocytes in your blood.My bilirubin levels are high, but not because of Gilbert's syndrome.Your liver enzymes (ALT, AST) are more than 2.5 times the normal level.My INR is over 1.6 and I am not on full dose warfarin.There is a high level of protein in your urine.My cancer is at stage IV or inoperable stage IIIB.I do not have any major heart problems.My cancer can be measured by scans taken within the last 28 days.You are expected to live for at least 12 more weeks.I am not pregnant.You have a sufficient number of a type of white blood cells called granulocytes in your blood.Your platelet count is at least 100,000 per microliter.Your creatinine level in the blood is less than or equal to 2.0 milligrams per deciliter.My blood clotting time is normal or I'm on warfarin.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (endocrine therapy with monoclonal antibody)
- Group 2: Arm II (endocrine therapy)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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